Hydroxychloroquine sulfate

Plasmodial heme polymerase inhibitor with anti-inflamatory properties.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

40
Supporting references
0
Contradictory references
9
AI-suggested references
28
Clinical trials

General information

Hydroxychloroquine (sulphate) has chemotherapeutic and antibacterial properties. It acts on parasites inviding erythrocytes through inhibition of plasmodial polymerase and through other unknown mechanisms. It was shown to have anti-inflamatory properties and is used for treatment of certain autoimmune diseases (NCIt).

Hydroxychloroquine might inhibit glycosylation of ACE2, which could impair SARS-CoV-2 entry into cells (DrugBank). Data of Ou et al. (2021) suggest that hydroxychloroquine blocks cathepsin L mediated viral entry in endosomes but does not impede TMPRSS2 mediated entry at the cell membrane.

On March 28, 2020, the FDA issued the Emergency Use Authorization for hydroxychloroquine sulfate for the treatment of COVID-19.

On May 23, 2020, the World Health Organization said it is temporarily halting its clinical trials that use hydroxychloroquine to treat COVID-19 patients over safety concerns. One of the key studies that lead to this conclusion was “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis", which reported the occurrence of arrhythmias associated with the use of hydroxychloroquine. This study was met with concerns regarding statistical analysis and data integrity. Following the critique, the study was retracted by three of their authors.

RECOVERY trial chief investigators stated that based on NO significant difference in 28-day mortality between hospitalized COVID-19 patients treated with hydroxychloroquine and those with usual care only, further patient recruitment was halted.

On June 15, 2020, the Emergency Use Authorization for hydroxychloroquine sulfate for the treatment of COVID-19 was REVOKED by the FDA

On July 4, 2020, WHO announced the hydroxychloroquine arm of the Solidarity Trial in hospitalized patients was discontinued. 

A living WHO guideline on drugs for covid-19 (as of March 4, 2022) strongly recommends AGAINST the use of hydroxychloroquine for the treatment of COVID-19.

Hydroxychloroquine sulfate on DrugBank
Hydroxychloroquine sulfate on PubChem
Hydroxychloroquine sulfate on Wikipedia






Marketed as

HYDROXYCHLOROQUINE SULFATE; DOLQUINE; HCQS; POLIRREUMIN; PLAQUENIL; QUENSYL

 

Structure image - Hydroxychloroquine sulfate

CCN(CCCC(C)NC1=C2C=CC(=CC2=NC=C1)Cl)CCO.OS(=O)(=O)O


Supporting references

Link Tested on Impact factor Notes Publication date
In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
VERO E6 cell cultures

More potent than chloroquine, a dose of 400 mg twice daily of hydroxychloroquine sulfate given orally, followed by a maintenance dose of 200 mg given twice daily for 4 days is recommended for SARS-CoV-2 infection

Mar/09/2020
Evaluation of Flavonoids as 2019-nCoV Cell Entry Inhibitor Through Molecular Docking and Pharmacological Analysis
Preprint In silico
in silico Apr/06/2020
Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial
Patients

better in combination with azithromycin

Mar/20/2020
National Consumption of Antimalarial Drugs and COVID-19 Deaths Dynamics : an Ecological Study
Patients Apr/24/2020
Pharmacokinetic bases of the hydroxychloroquine response in COVID-19: implications for therapy and prevention
in silico

the drug needs to be administered early enough (i.e. when viral loads range from 1 to 1,000 copies/mL)

Apr/28/2020
Experience with Hydroxychloroquine and Azithromycin in the COVID-19 Pandemic: Implications for QT Interval Monitoring
Preprint
Patients

12 % of patients treated with hydroxychloroquine plus azithromycin achieved a critical level of QTc interval prolongation

Apr/25/2020
Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro
VERO E6 cell cultures

more potent than chloroquine

Mar/18/2020
A pilot study of hydroxychloroquine in treatment of patients with common coronavirus disease-19 (COVID-19)
Patients Mar/06/2020
Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial
Patients Apr/10/2020
Hydroxychloroquine in patients with COVID-19: an open-label, randomized, controlled trial
Preprint Randomized controlled open trial
Patients

30 % of hydroxychloroquine recipients had adverse effects, most often diarrhea

Apr/14/2020
Hydroxychloroquine application is associated with a decreased mortality in critically ill patients with COVID-19
Preprint Critical severity
Patients May/01/2020
Zinc sulfate in combination with a zinc ionophore may improve outcomes in hospitalized COVID-19 patients
RdRpol Small molecule Cohort study
Patients 2.16

in combination with azithromycin alone or even better in combination with azithromycin plus zinc sulfate

Sep/15/2020
Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study.
Patients

in combination with azithromycin

Apr/11/2020
The SARS-CoV-2 cytopathic effect is blocked with autophagy modulators
Preprint
VERO E6 cell cultures May/21/2020
Doxycycline and Hydroxychloroquine as Treatment for High-Risk COVID-19 Patients: Experience from Case Series of 54 Patients in Long-Term Care Facilities
Preprint Case series
Patients

in combination with doxycycline

May/22/2020
A short therapeutic regimen based on hydroxychloroquine plus azithromycin for the treatment of COVID-19 in patients with non-severe disease. A strategy associated with a reduction in hospital admissions and complications.
Preprint
Patients

in combination with azithromycin

Jun/12/2020
Viral Dynamics Matter in COVID-19 Pneumonia: the success of early treatment with hydroxychloroquine and azithromycin in Lebanon.
Preprint
Patients

in combination with azithromycin

Jun/02/2020
Oral drug repositioning candidates and synergistic remdesivir combinations for the prophylaxis and treatment of COVID-19
Preprint In vitro Screening
HeLa-ACE2 cells Jun/16/2020
Chronic treatment with hydroxychloroquine and SARS-CoV-2 infection
Patients 2.02

chronic treatment with hydroxychloroquine confers protection against SARS-CoV-2 infection

Jun/29/2020
Identification of Potent and Safe Antiviral Therapeutic Candidates Against SARS-CoV-2
Small molecule In vitro Screening
Vero cells 5.09 Nov/25/2020
Enantiomers of Chloroquine and Hydroxychloroquine Exhibit Different Activities Against SARS-CoV-2 in vitro, Evidencing S-Hydroxychloroquine as a Potentially Superior Drug for COVID-19
Preprint
VERO E6 cell cultures

S-enantiomer is 60% more active against SARS-CoV-2 than R-enantiomer

May/27/2020
Broad anti-coronaviral activity of FDA approved drugs against SARS-CoV-2 in vitro and SARS-CoV in vivo
Small molecule Animal model
BALB/c mice; A549 lung adenocarcinoma cells expressing ACE2; Vero E6 cells; SARS-CoV-2 strain MA15 4.32

Inhibits the production of infectious viral particles in vitro and decreases viral gene RNA levels.

Aug/19/2020
Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study
Preprint Randomized controlled open trial Moderate severity
Patients Jun/22/2020
Hydroxychloroquine with or without azithromycin and in-hospital mortality or discharge in patients hospitalized for COVID-19 infection: a cohort study of 4,642 in-patients in France
Preprint Cohort study
Patients

higher rates of discharge home

Jun/19/2020
New Anti SARS-Cov-2 Targets for Quinoline Derivatives Chloroquine and Hydroxychloroquine
Envelope protein Small molecule In silico
in silico 4.56

Predicted to have impact on the functionality of the SARS-CoV-2 envelope (E) protein and also to influence proofreading and capping of the viral RNA.

Aug/14/2020
A comprehensive strategy for the early treatment of COVID-19 with azithromycin/hydroxychloroquine and/or corticosteroids: Results of a retrospective observational study in the French overseas department of Réunion Island
Small molecule Cohort study
Patients 2.71

Treatment with hydroxychloroquine/azithromycin resulted in lower ICU admission rate in patients who developed hypoxaemic pneumonia. Sample size: 23. Dosage: 400 mg twice on day 1, 200 mg twice daily on days 2-10, in combination with azithromycin (500 mg on day 1, 250 mg daily on days 2-5).

Aug/20/2020
Inhibitory activity of hydroxychloroquine on COVID-19 main protease: An insight from MD-simulation studies
3CLpro Small molecule In silico
in silico 2.46

Predicted to inhibit the SARS-CoV-2 3C-like protease.

Jun/02/2020
Low-dose hydroxychloroquine therapy and mortality in hospitalised patients with COVID-19: a nationwide observational study of 8075 participants
Small molecule Cohort study
Patients 4.62

Decreased mortality irrespective of symptoms duration in patients treated with low dosage of HCQ. Sample size: 4542 + 3533 control. Dosage: 2400 mg over 5 days.


Aug/24/2020
Synergistic antiviral effect of hydroxychloroquine and azithromycin in combination against SARS-CoV-2: What molecular dynamics studies of virus-host interactions reveal
Spike protein Small molecule In silico
in silico 4.62

Predicted to bind to the host's gangliosides at the virus attachment sites and thereby act synergically with azithromycin to prevent the SARS-CoV-2 infection.

May/13/2020
Clinical improvement in a patient with severe coronavirus disease 2019 after administration of hydroxychloroquine and continuous hemodiafiltlation with nafamostat mesylate
Severe severity Small molecule Case report
Patient 1.72

Used in parallel to continuous hemodiafiltration with nafamostat mesylate. Clinical improvement in a severe COVID-19 patient not responding to the lopinavir/ritonavir therapy. Dosage: 400 mg.

Aug/06/2020
Antimalarial drugs inhibit the replication of SARS-CoV-2: An in vitro evaluation
Small molecule In vitro
Vero E6 cells; SARS-CoV-2 IHUMI-3 strain 4.59

The antimalarial drug inhibited SARS-CoV-2 in vitro at IC50 and IC90 similar to the concentrations reached during oral antimalarial treatment.

Sep/08/2020
Effect of combination therapy of hydroxychloroquine and azithromycin on mortality in COVID‐19 patients
Small molecule Cohort study
Patients 3.37

Administered together with azithromycin. Reduced in-hospital mortality in treated patients. Non-treated cohort patients were contraindicated for the treatment. Sample size: 297 + 63 control. Dosage: 200 mg twice daily for 10 days.


Sep/14/2020
Chloroquine and hydroxychloroquine as ACE2 blockers to inhibit viropexis of 2019-nCoV Spike pseudotyped virus
ACE2 Biophysical assay Small molecule In vitro
in silico; in vitro biophysical assay; ACE2 high-expressing HEK293T cells 4.27

Blocks SARS-CoV-2 pseudotyped virus entry into cells in vitro and binds ACE2 in vitro but is slightly more cytotoxic than chloroquine.

Sep/02/2020
Early Hydroxychloroquine Administration for Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Eradication
Patients

Early administration of HCQ ameliorates inflamatory cytokine secretion, shortens viral shedding duration and increases viral clearance rate at 30 days. It shortens temperature recovery duration but no significant improvement in radiologic recovery duration was observred. Sample size 99. Endpoints - viral clearance rates; clinical improvement (body temperature, radiologic findings).

Jul/16/2020
Assessment of COVID‐19 Treatment containing both Hydroxychloroquine and Azithromycin: A Natural Clinical Trial
Non-randomized non-controlled open trial Small molecule
Patients 2.44

In combination with azithromycin. Treatment was associated with significant reduction of COVID-19 symptoms and recovery in most patients. There was no control group within the study, however. Sample size: 161. Dosage: 400 mg twice daily on day 1; 200 mg twice daily on days 2-5 (-14 in pneumonia patients).

Nov/24/2020
Drug repurposing for COVID-19 using machine learning and mechanistic models of signal transduction circuits related to SARS-CoV-2 infection
Protein factor Small molecule Antibody In silico
in silico (machine learning) 13.49

Considered by the authors to be among the most relevant drugs identified in a machine-learning algorithm-based screening of compounds which considers causal protein-protein interactions, known drug targets, and specific signalling circuits in

Dec/11/2020
Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: a multi-center observational study
Small molecule Mild severity Cohort study
Mild COVID-19 outpatients 2.69

Hydroxychloroquine use in outpatients with mild COVID-19 was associated with lower hospitalization rate compared to control. Sample size: 97 + 1177 control. Endpoint: Need for hospitalization.


Jan/14/2021
Hydroxychloroquine-mediated inhibition of SARS-CoV-2 entry is attenuated by TMPRSS2
Spike protein TMPRSS2 Cathepsin L In vitro Mechanism
hACE2-HEK293T cells; hACE2-H1299 cells; hACE2-H1975 cells; Vero cells; Calu-3 cells; SARS-CoV-2 S pseudovirus 6.22

Acts synergistically with

Jan/19/2021
Chloroquine and Hydroxychloroquine Interact Differently with ACE2 Domains Reported to Bind with the Coronavirus Spike Protein: Mediation by ACE2 Polymorphism
ACE2 Small molecule In silico
in silico 3.27

Predicted (especially the S enantiomer) to interact with the host's ACE2 receptor to a degree which is influenced by the polymorphisms in the receptor.

Jan/28/2021
A Randomized, Double-Blind, Multicenter Clinical Study Comparing the Efficacy and Safety of a Drug Combination of Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, and Azithromycin-Hydroxychloroquine...
Small molecule Randomized controlled double-blind trial Moderate severity Mild severity
Mild to moderate COVID-19 patients 2.44

In combination with <a href=

Feb/09/2021

AI-suggested references

Clinical trials

ID Title Status Phase Start date Completion date
NCT04389359 PROphylaxis for paTiEnts at Risk of COVID-19 infecTion Withdrawn Phase 2|Phase 3 Sep/01/2020 Aug/01/2025
  • Alternative id - A095590
  • Interventions - Drug: Hydroxychloroquine Sulfate 200 MG
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time to confirmed diagnosis of COVID-19|All-cause mortality|Severity of COVID-19 disease|Incidence of COVID-19 complications
NCT04371926 Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk Withdrawn Not Applicable Jun/01/2020 Jul/01/2021
  • Alternative id - TCAI_PREVENT
  • Interventions - Drug: Hydroxychloroquine Sulfate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Prevention
  • Enrollment - 0
  • Age - 18 Months to 85 Years   (Child, Adult, Older Adult)
  • Outcome measures - Time to reach normal body temperature|Development of COVID-19 symptoms during HCQ preventive therapy in staff|COVID-19 test result at follow-up in patients|Worsening of symptoms in COVID-19 patients
NCT04329572 Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Hospitalized Patients With Moderate to Severe COVID-19 Suspended Early Phase 1 Apr/23/2020 Jun/30/2020
  • Alternative id - HIAPRE0320OR
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Azithromycin Tablets
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Prevent Senior Private Operadora de Saúde LTDA., São Paulo, Brazil
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 400
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability|Viral load|Change in Clinical Condition|Evolution of Acute Respiratory Syndrome|Hospital discharge|Rate of mortality within 28-days
NCT04354441 Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women Withdrawn Phase 2 May/01/2020 May/01/2020
  • Alternative id - 1, March 30, 2020
  • Interventions - Drug: hydroxychloroquine sulfate 200 MG|Drug: Placebo oral tablet
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years to 50 Years   (Adult)
  • Outcome measures - COVID-19-related hospital admissions|Symptoms related to COVID-19 infection|Adverse Events|Maternal outcomes|Newborn outcomes
NCT04384380 Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19 Completed Not Applicable Apr/01/2020 May/31/2020
  • Alternative id - TYGH109014
  • Interventions - Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan City, Taiwan
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 33
  • Age - 20 Years to 79 Years   (Adult, Older Adult)
  • Outcome measures - Time to negatively RT-PCR|Virologic assessment|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
NCT04380818 Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19 Recruiting Not Applicable Jun/05/2020 Nov/01/2021
  • Alternative id - IPACOVID
  • Interventions - Radiation: Low-dose radiotherapy|Drug: Hydroxychloroquine Sulfate|Drug: Ritonavir/lopinavir|Drug: Tocilizumab Injection [Actemra]|Drug: Azithromycin|Drug: Corticosteroid|Drug: Low molecular weight heparin|Device: Oxygen supply
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Sant Joan de Reus, Reus, Tarragona, Spain|Hospital Del Mar, Barcelona, Spain|Hospital Universitario Madrid Sanchinarro, Madrid, Spain
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
  • Enrollment - 106
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|Change of the radiological image|Overall mortality|Measure of pro-inflammatory interleukins|Measure of trasforming growth factor (TGF-b)|Measure of tumor necrosis factor alpha (TNF-a)|Determining overexpression of pro-inflammatory selectin|Determining cell adhesion molecules (CAMs)|Measure of marker of oxidative stress PON-1
NCT04359537 Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 Recruiting Phase 2 May/01/2020 Sep/25/2020
  • Alternative id - F.1-1/2015/ERB/SZABMU/549
  • Interventions - Drug: Hydroxychloroquine Sulfate 200 MG|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Shaheed Zulfiaqar Ali Bhutto Medical University, Islamabad, Federal Capital, Pakistan
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention
  • Enrollment - 200
  • Age - 18 Years to 60 Years   (Adult)
  • Outcome measures - COVID-19-free survival in experimental arms compared to placebo|Incidence of confirmed SARS-COV-2 detection|Incidence of possible COVID-19 symptoms|Incidence of all-cause study medicine discontinuation|Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end|Incidence of Hospitalization for COVID-19 or death|Incidence of study medication-related adverse events
NCT04326725 Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia Active, not recruiting Mar/20/2020 Sep/01/2020
  • Alternative id - 2020-2/1
  • Interventions - Drug: Plaquenil 200Mg Tablet
  • Study type - Observational
  • Study results - No Results Available
  • Locations - Istinye University Medical School, Istanbul, Turkey
  • Study designs - Observational Model: Case-Control|Time Perspective: Prospective
  • Enrollment - 80
  • Age - 20 Years to 90 Years   (Adult, Older Adult)
  • Outcome measures - Protection against COVID-19
NCT04346667 Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds Terminated Phase 4 Apr/14/2020 Aug/30/2020
  • Alternative id - NBC-COVID19-02
  • Interventions - Drug: Hydroxychloroquine Sulfate Regular dose|Drug: Hydroxychloroquine Sulfate Loading Dose|Drug: Chloroquine|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Expo Covid Center, Lahore, Punjab, Pakistan|Mayo Hospital, Lahore, Punjab, Pakistan|Pakistan Kidney and Liver Institute, Lahore, Punjab, Pakistan
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 125
  • Age - 20 Years to 50 Years   (Adult)
  • Outcome measures - RT-PCR negative status|Progression of symptoms|Development of Symptoms|Adverse events
NCT04340349 Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals Enrolling by invitation Early Phase 1 Feb/01/2021 Jun/30/2021
  • Alternative id - 25/20
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Bromhexine 8 MG
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - National Institute of Rehabilitation, Luis Guillermo Ibarra Ibarra, Mexico City, Cdmx, Mexico
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 214
  • Age - 18 Years to 59 Years   (Adult)
  • Outcome measures - Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2
NCT04361461 Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19) Withdrawn Phase 3 Apr/30/2020 Nov/04/2020
  • Alternative id - APS000/2020
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Hydroxychloroquine Sulfate + Azythromycin
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Apsen Farmacêutica S.A., São Paulo, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Individual response rate|All-cause mortality|Duration of mechanical ventilation|Proportion of patients which needed mechanical ventilation during study|World Health Organization (WHO) Ordinal scale|Duration of hospitalization|Rates of drug discontinuation
NCT04446104 A Preventive Treatment for Migrant Workers at High-risk of COVID-19 Completed Phase 3 May/13/2020 Aug/31/2020
  • Alternative id - 2020/00561
  • Interventions - Drug: Hydroxychloroquine Sulfate Tablets|Drug: Ivermectin 3mg Tab|Drug: Zinc|Drug: Povidone-Iodine|Dietary Supplement: Vitamin C
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Tuas South Dormitory, Singapore, Singapore
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 4257
  • Age - 21 Years to 60 Years   (Adult)
  • Outcome measures - Laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Acute respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Febrile respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Rate of hospitalization for COVID-19 and non-COVID-19 related indications in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Rate of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Duration of oxygen supplementation and mechanical ventilation in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Length of hospital stay in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Rate of laboratory-confirmed COVID-19 in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine)|Adverse events and serious adverse events in control arm (Vitamin C)|Drug discontinuation due to adverse events in control arm (Vitamin C)
NCT04342156 Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19 Withdrawn Phase 3 Apr/01/2020 Oct/01/2020
  • Alternative id - 2020/00402
  • Interventions - Drug: Hydroxychloroquine Sulfate 200 milligram (mg) Tab
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 0
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.|Positive serology at day 28.|Symptoms of COVID-19.
NCT04374552 Asymptomatic COVID-19 Trial Withdrawn Phase 2 May/05/2020 Apr/01/2021
  • Alternative id - Pro2020000872
  • Interventions - Drug: Hydroxychloroquine sulfate &Azithromycin|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 20 Years and older   (Adult, Older Adult)
  • Outcome measures - The primary outcome is the rate of decline in viral load over the 10 days after randomization
NCT04354428 Treatment for COVID-19 in High-Risk Adult Outpatients Active, not recruiting Phase 2|Phase 3 Apr/16/2020 Jan/01/2021
  • Alternative id - STUDY00009878|INV-017062
  • Interventions - Drug: Ascorbic Acid|Drug: Hydroxychloroquine Sulfate|Drug: Azithromycin|Drug: Folic Acid|Drug: Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ruth M. Rothstein CORE Center - Cook County Health, Chicago, Illinois, United States|Tulane University, New Orleans, Louisiana, United States|Boston University, Boston, Massachusetts, United States|SUNY Upstate Medical University, Syracuse, New York, United States|University of Washington Coordinating Center, Seattle, Washington, United States|UW Virology Research Clinic, Seattle, Washington, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
  • Enrollment - 300
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Lower respiratory tract infection (LRTI) rates|Incidence of hospitalization or mortality|Change in upper respiratory viral shedding|COVID-19 symptom resolution rates [Lopinavir-ritonavir arm only]|Rate of participant-reported adverse events|COVID-19-related hospitalization days|Rate of disease severity|Viral shedding rates|Individual lopinavir-ritonavir concentration profiles and exposure estimates [Lopinavir-ritonavir arm only]
NCT04345653 Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers Completed Phase 2 Apr/14/2020 May/10/2021
  • Alternative id - Pro2020-0356
  • Interventions - Drug: Hydroxychloroquine Sulfate (HCQ)
  • Study type - Interventional
  • Study results - Has Results
  • Locations - Hackensack Meridian Health - JFK Medical Center, Edison, New Jersey, United States
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 48
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Recruitment Feasibility|Resource Utilization|Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse Events|Early Feasibility as Reflected on the Number of Participants Contracting COVID-19 (10% or Less) in Comparison to the Expected 30% as Per CDC.
NCT04348474 Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19 Suspended Early Phase 1 Apr/20/2020 Jul/31/2020
  • Alternative id - HIAPRE0420OR
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Azithromycin Tablets
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Prevent Senior Private Operadora de Saúde LTDA., São Paulo, Brazil
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 200
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Change in Clinical Condition|Hospitalization|Rate of mortality within 28-days|Change in Clinical Condition related to comorbidity
NCT04329923 The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine) Terminated Phase 2 Apr/09/2020 Nov/13/2020
  • Alternative id - 842838
  • Interventions - Drug: Hydroxychloroquine Sulfate 400 mg twice a day|Drug: Hydroxychloroquine Sulfate 600 mg twice a day|Drug: Hydroxychloroquine Sulfate 600 mg once a day|Drug: Placebo oral tablet
  • Study type - Interventional
  • Study results - Has Results
  • Locations - University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 173
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time to Release From Quarantine Time|Time to Hospital Discharge|Number of Health Care Workers Who Developed SARS-COV-2 Infection|Rate of Housemate Infection|Rate of Hospitalization
NCT04336332 Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19 Active, not recruiting Phase 2 Apr/01/2020 Jun/30/2022
  • Alternative id - Pro2020000712|002011
  • Interventions - Combination Product: Hydroxychloroquine Sulfate + Azithromycin|Drug: Hydroxychloroquine Sulfate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Saint Barnabas Medical Center, Livingston, New Jersey, United States|Robert Wood Johnson University Hopsital, New Brunswick, New Jersey, United States|Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States|The University Hospital, Newark, New Jersey, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 160
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Changes in patients viral load|Second evaluation of changes in patients viral load|Symptom questionnaire|Fever assessment|Vital Signs - Body Temperature|Discharge|Recovery|Assessment of agent toxicity|Oropharynx swab sample collections|Blood Sample collections|Viral shedding assessment - nasopharyngeal secretions|Viral shedding assessment - serology|Cytokines in blood
NCT04341727 Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection Terminated Phase 3 Apr/04/2020 Apr/01/2021
  • Alternative id - 202003188
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Azithromycin|Drug: Chloroquine Sulfate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Washington University School of Medicine Infectious Disease Clinical Research Unit, Saint Louis, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 31
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Hours to recovery|Time fever resolution
NCT04342221 Hydroxychloroquine for COVID-19 Terminated Phase 3 Mar/29/2020 Feb/26/2021
  • Alternative id - COV-HCQ|2020-001224-33
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Zollernalb Klinikum Balingen, Balingen, Germany|Klinikum Darmstadt, Darmstadt, Germany|Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany|Johannes Wesling Klinikum Minden, Minden, Germany|Klinikum am Steinenberg, Reutlingen, Germany|RoMed Klinikum Rosenheim, Rosenheim, Germany|Robert-Bosch-Krankenhaus, Stuttgart, Germany|Institute for Tropical Medicine, Tübingen, Germany
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 30
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Effect of HCQ on in vivo viral clearance
NCT04307693 Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19) Terminated Phase 2 Mar/11/2020 Apr/30/2020
  • Alternative id - S2020-0472-0001
  • Interventions - Drug: Lopinavir/ritonavir|Drug: Hydroxychloroquine sulfate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 65
  • Age - 16 Years to 99 Years   (Child, Adult, Older Adult)
  • Outcome measures - Viral load|Viral load change|Time to clinical improvement (TTCI)|Percentage of progression to supplemental oxygen requirement by day 7|Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7|Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission|Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7|adverse effects|Concentration of Lopinavir/ritonavir and hydroxychloroquine
NCT04403100 Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" Recruiting Phase 3 Jun/03/2020 Feb/01/2021
  • Alternative id - COVID19_AMB_Brasil
  • Interventions - Drug: Hydroxychloroquine Sulfate Tablets|Drug: Lopinavir/ Ritonavir Oral Tablet|Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - CARDRESEARCH - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil|Pontificia Universidade Catolica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Fundo Municipal de Saúde de Betim, Betim, Minas Gerais, Brazil|Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 1968
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Proportion of participants who were hospitalized for progression of COVID-19 disease|Proportion of participants who died due to COVID-19 progression and/ or complications|Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization|Time to clinical improvement|Time to clinical failure|Hospitalization for any cause|Proportion of participants who died due to pulmonary complications|Proportion of participants who died due to cardiovascular complications|Proportion of participants who presented with adverse events|Time to improvement on respiratory scale symptoms|proportion of non-adherent participants to any of study drugs
NCT04392128 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE) Withdrawn Phase 2 Sep/02/2020 Sep/02/2020
  • Alternative id - 2020-005|2020-002002-45
  • Interventions - Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]|Drug: Azithromycin 250 MG Oral Capsule|Drug: Placebo oral tablet|Drug: Placebo oral capsule
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Institut de Cancérologie Strasbourg Europe, Strasbourg, France
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.|Clinical evolution|Proportion of patients progressing to a severe form|Mortality|Evaluation of viral load drop|Tolerance of study treatment|Evaluation of the seroconversion|NK immunological study|Hospitalisation duration|Impact of the study treatment on the treatment of the hematological disease|Monitoring of the QT space|Dosage of residual concentration of azithromycine and hydroxychloroquine.|T immunological study
NCT04351191 PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds Terminated Phase 4 Apr/15/2020 Aug/30/2020
  • Alternative id - NBC-COVID1902
  • Interventions - Drug: Hydroxychloroquine Sulfate Regular dose|Drug: Hydroxychloroquine Sulfate Loading Dose|Drug: Chloroquine|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Expo Covid Isolation Center / Mayo Hospital Field Hospital, Lahore, Punjab, Pakistan|Mayo Hospital / King Edward Medical University, Lahore, Punjab, Pakistan|Pakistan Kidney and Liver Institute, Lahore, Punjab, Pakistan|Services Hospital, Lahore, Punjab, Pakistan
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 137
  • Age - 20 Years to 50 Years   (Adult)
  • Outcome measures - RT-PCR result|Progression of symptoms|Mortality
NCT04316377 Norwegian Coronavirus Disease 2019 Study Active, not recruiting Phase 4 Mar/25/2020 Mar/03/2025
  • Alternative id - REC 121446
  • Interventions - Drug: Hydroxychloroquine Sulfate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Akershus University Hospital, Lørenskog, Norway
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 53
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Rate of decline in SARS-CoV-2 viral load|Change in National Early Warning Score score|Admission to intensive care unit|In-hospital mortality|Duration of hospital admission|Mortality at 30 and 90 days|Clinical status|Change in C-reactive protein concentrations|Change in alanine aminotransferase concentrations|Change in aspartate aminotransferase concentrations|Change in bilirubin concentrations|Change in estimated glomerular filtration rate|Change in cardiac troponin concentrations|Change in natriuretic peptide concentrations
NCT04328961 Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) Completed Phase 2|Phase 3 Mar/31/2020 Oct/08/2020
  • Alternative id - STUDY00009750|INV-016204
  • Interventions - Drug: Hydroxychloroquine Sulfate|Drug: Ascorbic Acid
  • Study type - Interventional
  • Study results - Has Results
  • Locations - University of California Los Angeles, Los Angeles, California, United States|Tulane, New Orleans, Louisiana, United States|University of Maryland, Baltimore, Baltimore, Maryland, United States|Boston University, Boston, Massachusetts, United States|NYU Langone Health, New York, New York, United States|SUNY Upstate Medical University, Syracuse, New York, United States|University of Washington, Coordinating Center, Seattle, Washington, United States|UW Virology Research Clinic, Seattle, Washington, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 943
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection|The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection|Rate of Participant-reported Adverse Events|Number of Participants Who Had COVID-19 Disease
NCT04461353 A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers Completed Phase 1 Jun/25/2020 Aug/17/2020
  • Alternative id - PUL-01
  • Interventions - Drug: Aerolized Hydroxychloroquine Sulfate|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - The Rockefeller University, New York, New York, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 12
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidences of treatment-emergent adverse events (TEAEs) as assessed by TGSHAAV (September 2007) or CTCAE version 5.0|Change from baseline in clinical laboratory test results for CBC with differential|Incidence of abnormal laboratory test results for CBC with differential at Screening|Incidence of abnormal laboratory test results for CBC with differential - Day 8|Changes from baseline for blood glucose|Incidence of abnormal laboratory test results for chemistry -Screening|Incidence of abnormal laboratory tests results for chemistry - Day 8|Incidence of abnormal laboratory tests results for urinalysis - Screening|Incidence of abnormal laboratory tests results for urinalysis- Day 8|Changes in vital signs from baseline (pre-dose) - respiratory rate|Changes in vital signs from baseline (pre-dose)- temperature|Changes in vital signs from baseline (pre-dose) - seated blood pressure|Changes in vital signs from baseline (pre-dose) - pulse|Changes in vital signs from baseline (pre-dose) - O2 saturation|Incidence of abnormal and physical examinations findings during Screening- general appearance|Incidence of abnormal and physical examinations findings on Day 1 - general appearance|Incidence of abnormal and physical examinations findings on Day 2- general appearance|Incidence of abnormal and physical examinations findings on Day 8- general appearance|Incidence of abnormal and physical examinations findings during Screening- neurological|Incidence of abnormal and physical examinations findings on Day 1- neurological|Incidence of abnormal and physical examinations findings on Day 2- neurological|Incidence of abnormal and physical examinations findings on Day 8- neurological|Incidence of abnormal and physical examinations findings during Screening - heart/cardiovascular|Incidence of abnormal and physical examinations findings on Day 1 - heart/cardiovascular|Incidence of abnormal and physical examinations findings on Day 2 - heart/cardiovascular|Incidence of abnormal and physical examinations findings on Day 8 - heart/cardiovascular|Incidence of abnormal and physical examinations findings during Screening - lungs|Incidence of abnormal and physical examinations findings on Day 1 - lungs|Incidence of abnormal and physical examinations findings on Day 2 - lungs|Incidence of abnormal and physical examinations findings on Day 8 - lungs|Incidence of abnormal and physical examinations findings during Screening- abdomen|Incidence of abnormal and physical examinations findings on Day 1 - abdomen|Incidence of abnormal and physical examinations findings on Day 2- abdomen|Incidence of abnormal and physical examinations findings on Day 8- abdomen|Incidence of abnormal and physical examinations findings during screening- endocrine|Incidence of abnormal and physical examinations findings on Day 1 - endocrine|Incidence of abnormal and physical examinations findings on Day 2- endocrine|Incidence of abnormal and physical examinations findings on Day 8- endocrine|Incidence of abnormal and physical examinations findings during Screening- extremities|Incidence of abnormal and physical examinations findings on Day 1- extremities|Incidence of abnormal and physical examinations findings on Day 2- extremities|Incidence of abnormal and physical examinations findings on Day 8- extremities|Incidence of abnormal and physical examinations findings during Screening- lymphatic|Incidence of abnormal and physical examinations findings on Day 1- lymphatic|Incidence of abnormal and physical examinations findings on Day 2 - lymphatic|Incidence of abnormal and physical examinations findings on Day 8- lymphatic|Incidence of abnormal and physical examinations findings during screening - skin|Incidence of abnormal and physical examinations findings on Day 1 - skin|Incidence of abnormal and physical examinations findings on Day 2 - skin|Incidence of abnormal and physical examinations findings on Day 8 - skin|Changes from baseline for pulmonary function tests (PFTs) - FEV1|Changes from baseline for pulmonary function tests (PFTs) - FVC|Changes from baseline for pulmonary function tests (PFTs) - FEV1/FVC|Changes from baseline for ECG readings - QT interval|Changes from baseline for ECG readings - QTcB Interval|Changes from baseline for ECG readings - QRS duration|Changes from baseline for ECG readings - PR interval|Changes from baseline for ECG readings - heart rate|Incidence of abnormal ECG - Screening|Incidence of abnormal ECG- Day 1|Incidence of abnormal ECG - Day 2|Incidence of abnormal ECG - Day 8|HCQ concentration in whole blood versus time profiles