Other substances

Nitazoxanide

A synthetic benzamide antiparasitic drug.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

7
 Supporting references
0
 Contradictory references
32
 AI-suggested references
31
 Clinical trials

General information

Nitazoxanide is a synthetic benzamide antiprotozoal (NCIt). It has been also studied for antiviral properties (DrugBank).

Nitazoxanide on PubChem
Nitazoxanide on Wikipedia


Marketed as

ALINIA; ALPEX NIZOX; ANNITA; AZOXANID; CELECTAN; COLUFASE; COLUQUIM; DAXON; DIANIDE; DIAR; FAMIDOX; KASIDE; KAZIDE; LARVISOL; LUMBRIS; MIXEL; NIAZID; NITAX; NITAXIDE; NITAZET; NITAZOFIN; NODIK; OMNIPARAX

 

Structure image - Nitazoxanide

CC(=O)OC1=CC=CC=C1C(=O)NC2=NC=C(S2)[N+](=O)[O-]

Supporting references

Link Tested on Impact factor Notes Publication date
Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro
VERO E6 cell cultures

High concentrations were required to reduce the viral infection

 Feb/04/2020
Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis
Preprint 		in silico

The model predicted optimal doses of 1200 mg QID, 1600 mg TID, 2900 mg BID in the fasted state and 700 mg QID, 900 mg TID and 1400 mg BID when given with food

 May/06/2020
Discovery of Synergistic and Antagonistic Drug Combinations against SARS-CoV-2 In Vitro
Preprint In silico 		VERO E6 cell cultures

synergistic effect in combination with amodiaquine, remdesivir, arbidol, emetine dihydrochloride hydrate or NCGC00411883-01, but antagonistic effect in combination with cathepsin inhibitor 1

 Jul/01/2020
FDA-Approved Drugs with Potent In Vitro Antiviral Activity against Severe Acute Respiratory Syndrome Coronavirus 2
Spike protein 3CLpro Small molecule In vitro In silico 		in silico; Vero E6 cells; SARS-CoV-2 strain hCoV-19/Egypt/NRC-03/2020 4.29

Inhibited SARS-CoV-2 infection in Vero E6 cells at low-micromolar concentrations (IC50).

 Dec/04/2020
Repurposing of some anti‐infective drugs for COVID‐19 treatment: a surveillance study supported by an in silico investigation
Small molecule Randomized controlled open trial In silico 		in silico; patients 2.44

Administration of the drug in combination with azithromycin or doxycyclin resulted in significant clinical improvement in mild to moderate COVID-19 patients. Moreover, nitazoxanide was computationally predicted to bind ADPRP and AAK1, which are host factors with possible involvement in COVID-19 outcomes. Sample size: 20 (nitazoxanide + doxycycline)+ 20 (nitazoxanide + azithromycin) + 20 (doxycycline) + 20 (azithromycin). Dosage: 600 mg twice daily for 5 days.


 Dec/09/2020
Effect of a combination of Nitazoxanide, Ribavirin and Ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID‐19
Small molecule Non-randomized controlled open trial Phase I clinical trial Mild severity 		Mild COVID-19 patients 2.02

In combination with ribavirin, ivermectin, and zinc supplementation. Observed improvement in SARS-CoV-2 nasopharyngeal viral clearance at days 7 and 15 compared to control. Sample size: 62 + 51 control. Dosage: 500 mg (rapid release) every 6 hours. 


 Feb/16/2021
Development of a High-Throughput Screening Assay to Identify Inhibitors of the SARS-CoV-2 Guanine-N7-Methyltransferase Using RapidFire Mass Spectrometry
nsp14 Small molecule Enzyme assay In vitro 		in vitro enzyme assay 2.20

Inhibited SARS-CoV-2 methyltransferase nsp14 with an IC50 of 9.7 μM (modestly) in vitro.

 Mar/16/2021

AI-suggested references

Link Publication date
Thiazole-based SARS-CoV-2 protease (COV Mpro ) inhibitors: Design, synthesis, enzyme inhibition, and molecular modeling simulations.
Jan/20/2021
Nitazoxanide against COVID-19 in three explorative scenarios.
Aug/13/2021
In Vitro Data of Current Therapies for SARS-CoV-2.
Jun/24/2020
An Open Label, Adaptive, Phase 1 Trial of High-Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS-CoV-2
Oct/12/2020
Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial.
Jun/27/2021
On a knife's edge of a COVID-19 pandemic: is containment still possible?
Mar/09/2020
GRL-0920, an Indole Chloropyridinyl Ester, Completely Blocks SARS-CoV-2 Infection
Sep/11/2020
Drug repurposing of nitazoxanide: can it be an effective therapy for COVID-19?
Jul/28/2020
Effect of a combination of nitazoxanide, ribavirin, and ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-19
Jun/30/2021
Current status and strategic possibilities on potential use of combinational drug therapy against COVID-19 caused by SARS-CoV-2.
Jun/03/2020
Nitazoxanide in Patients Hospitalized With COVID-19 Pneumonia: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Apr/13/2022
Synthesis and antiplasmodial assessment of nitazoxanide and analogs as new antimalarial candidates
Sep/23/2021
Discovery of Potential Therapeutic Drugs for COVID-19 Through Logistic Matrix Factorization With Kernel Diffusion
Feb/28/2022
Early Antiandrogen Therapy With Dutasteride Reduces Viral Shedding, Inflammatory Responses, and Time-to-Remission in Males With COVID-19: A Randomized, Double-Blind, Placebo-Controlled Interventional Trial (EAT-DUTA AndroCoV Trial - Biochemical)
Jan/27/2021
A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19
Feb/28/2022
Synergistic and Antagonistic Drug Combinations against SARS-CoV-2
May/05/2021
Repurposing of some anti-infective drugs for COVID-19 treatment: A surveillance study supported by an in silico investigation
Dec/17/2020
Gastrointestinal and hepatic side effects of potential treatment for COVID-19 and vaccination in patients with chronic liver diseases
Nov/05/2021
Drug repurposing against SARS-CoV-1, SARS-CoV-2 and MERS-CoV
Apr/30/2021
Early COVID-19 therapy with azithromycin plus nitazoxanide, ivermectin or hydroxychloroquine in outpatient settings significantly improved COVID-19 outcomes compared to known outcomes in untreated patients.
Jul/07/2021
NSAIDs/nitazoxanide/azithromycin repurposed for COVID-19: potential mitigation of the cytokine storm interleukin-6 amplifier via immunomodulatory effects
Jun/15/2021
Prioritisation of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics
Jun/14/2020
Impairment of SARS-CoV-2 spike glycoprotein maturation and fusion activity by nitazoxanide: an effect independent of spike variants emergence
Apr/07/2022
Antiviral treatment of COVID-19
Jul/12/2021
Broad-spectrum therapeutics: A new antimicrobial class.
Dec/11/2020
Evolution of COVID-19 Pregnancies Treated With Nitazoxanide in a Third-Level Hospital.
May/13/2021
Pharmacogenomics and COVID-19: clinical implications of human genome interactions with repurposed drugs
Mar/23/2022
From hydroxychloroquine to ivermectin: what are the anti-viral properties of anti-parasitic drugs to combat SARS-CoV-2?
Jan/03/2022
Repurposing old drugs as antiviral agents for coronaviruses
May/23/2020
Therapeutic Potential of Nitazoxanide: An Appropriate Choice for Repurposing versus SARS-CoV-2?
Dec/22/2020
Blocking the interactions between human ACE2 and coronavirus spike glycoprotein by selected drugs: a computational perspective
Apr/01/2022
SARS-CoV-2 virus infection: Targets and antiviral pharmacological strategies
Nov/19/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT05157243 Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness Not yet recruiting Phase 3 Jan/01/2022 May/01/2022
  • Alternative id - RM08-3010
  • Interventions - Drug: Nitazoxanide|Dietary Supplement: Vitamin Super-B Complex|Drug: Placebo|Other: Standard of Care
  • 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 - 2000
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Proportion of participants progressing to severe COVID-19 or death from any cause
NCT04348409 Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19 Recruiting Not Applicable May/25/2020 Jul/31/2020
  • Alternative id - NITFQM0320OR
  • Interventions - Drug: Nitazoxanide Tablets|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Vera Cruz, Campinas, São Paulo, Brazil|Centro de Genomas, São Paulo, Brazil|Hospital Emílio Ribas, São Paulo, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 50
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Viral load|Evolution of acute respiratory syndrome|Change in Clinical Condition|Hospital discharge|Rate of mortality within 21-days|Need of mechanical ventilation
NCT04341493 Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19 Terminated Phase 4 Apr/06/2020 Dec/30/2020
  • Alternative id - 2020-03-681
  • Interventions - Drug: Nitazoxanide 500 MG|Drug: Hydroxychloroquine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Materno-Perinatal Hospital "Mónica Pretelini", Toluca, Mexico
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 44
  • Age - 5 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Mechanical ventilation requirement
NCT05157269 Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness Not yet recruiting Phase 3 Jan/01/2022 Apr/01/2022
  • Alternative id - RM08-3011
  • Interventions - Drug: Nitazoxanide|Drug: Placebo|Dietary Supplement: Vitamin Super-B Complex
  • 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 - 600
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - Time to sustained COVID-19 Recovery
NCT04561063 COVID-19 Prophylaxis South Africa (COVER HCW) Recruiting Phase 2 Dec/08/2020 Feb/28/2022
  • Alternative id - EZ-SS-025
  • Interventions - Drug: Nitazoxanide|Drug: Sofosbuvir/Daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, Gauteng, South Africa|Sunnyside Office Park, Johannesburg, Gauteng, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 1950
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Number of SARS-CoV-2 infections|Duration of symptoms|Maximum score on WHO Ordinal Scale|Time to onset of SARS-CoV-2 infection|Number of symptomatic SARS-CoV-2 infections|Number of asymptomatic SARS-CoV-2 infections|Peak score on modified Flu PRO
NCT04441398 Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients Not yet recruiting Phase 2|Phase 3 Jul/01/2020 Sep/01/2020
  • Alternative id - NITFQM0720OR
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • 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 - 300
  • Age - 50 Years and older   (Adult, Older Adult)
  • Outcome measures - Change in signs and symptoms scale|Incidence of Treatment-Emergent Adverse Events|The proportion of subjects hospitalized after start of treatment and before the end of the study|The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study|Duration of symptoms|Rate of mortality within 21-days
NCT04498936 Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19 Completed Phase 4 Jul/15/2020 Oct/30/2020
  • Alternative id - COVID-19 treatment
  • Interventions - Drug: Sofosbuvir and Ledipasvir|Drug: Nitazoxanide
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - 15th May Hospital, Helwan, Cairo, Egypt|Assiut University Hospital, Assiut, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 240
  • Age - 12 Years to 65 Years   (Child, Adult, Older Adult)
  • Outcome measures - Change of PCR from positive to negative|Clinical improvement|Adverse events
NCT04459286 The Nitazoxanide Plus Atazanavir for COVID-19 Study Terminated Phase 2 Oct/09/2020 May/02/2021
  • Alternative id - NACOVID
  • Interventions - Drug: Nitazoxanide and atazanavir/ritonavir|Other: Standard of Care
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria|Infectious Disease Hospital, Olodo, Ibadan, Oyo State, Nigeria
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 57
  • Age - 18 Years to 75 Years   (Adult, Older Adult)
  • Outcome measures - Time to clinical improvement|Time to SARS-CoV-2 negativity|Difference in SARS-CoV-2 AUC|Time to symptoms resolution|Clinical status as assessed with the seven-category ordinal scale on days 7 and 14|Duration of hospitalization in survivors|Day 28 mortality|Time from treatment initiation to death|Proportion with viral RNA detection over time
NCT04605588 A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19 Terminated Phase 2 Dec/02/2020 Feb/04/2021
  • Alternative id - Pro2020001862
  • Interventions - Drug: Nitazoxanide|Drug: Placebo Nitazoxanide|Drug: Ribavirin|Drug: Placebo Ribavirin|Drug: Hydroxychloroquine|Drug: Placebo Hydroxychloroquine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Robert Wood Johnson Medical School, 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 - 7
  • Age - 21 Years and older   (Adult, Older Adult)
  • Outcome measures - Rate of decline in viral load over the 10 days after randomization
NCT04463264 Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19) Recruiting Phase 2|Phase 3 Jun/26/2020 Dec/26/2020
  • Alternative id - NTZ-COVID ARG1
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Universitario Austral, Presidente Derqui, Buenos Aires, Argentina, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 135
  • Age - 18 Years to 59 Years   (Adult)
  • Outcome measures - Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th.|Comparative decrease of the viral load|Clinical improvement|Pneumonia patients meeting severity criteria.|Number of days with fever
NCT04486313 Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 Completed Phase 3 Aug/13/2020 Feb/08/2021
  • Alternative id - RM08-3008
  • Interventions - Drug: Nitazoxanide|Drug: Placebo|Dietary Supplement: Vitamin Super B-Complex
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Invesclinic US LLC, Fort Lauderdale, Florida, United States|RH Medical Urgent Care, Bronx, New York, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 1092
  • Age - 12 Years to 120 Years   (Child, Adult, Older Adult)
  • Outcome measures - Reducing the Time to Sustained Response|Reducing the Rate of Progression
NCT04959786 MANS-NRIZ Trial for COVID-19 Treatment : Extension Study Recruiting Phase 2|Phase 3 Apr/01/2021 Dec/01/2022
  • Alternative id - mu-med-2020-26
  • Interventions - Drug: Ivermectin,ribavirin ,nitazoxanide and zinc
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Mansoura University Hospital, Mansoura, Select A State Or Province, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Stabilization of oxygen|In-hospital and 28-day mortality|Negative conversion of SARS-CoV- 2 by Day 28|Time to clinical improvement
NCT04523090 Catalysing the Containment of COVID-19 Recruiting Phase 2|Phase 3 Aug/27/2020 Feb/01/2022
  • Alternative id - C3-RCT
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - The Aurum Institute, Tembisa, Gauteng, South Africa|University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa|Perinatal HIV Research Unit, Klerksdorp, North West, South Africa|University of Cape Town, Cape Town, Western Cape, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 440
  • Age - 18 Years to 120 Years   (Adult, Older Adult)
  • Outcome measures - Time specific disease severity|Progression to severe disease|Need for respiratory support (high flow nasal oxygen, non-invasive ventilation, or intubation) in those admitted to hospital because of disease progression.|In-hospital and 30- and 60-day all-cause mortality.|Time-specific viral load as measured by RT-PCR using NP swabs and sputum (where available).|Cough aerosol sampling positivity|Duration and severity of symptoms.|Time-specific antibody titres (IgG and IgM).|COVID-19 incidence rates in contacts.|Adverse events
NCT04561219 Nitazoxanide Therapy for Patients With COVID-19 Pneumonia Completed Phase 2 Apr/19/2020 Oct/02/2020
  • Alternative id - SARITA-1|RBR-88bs9x|30662420.0.1001.0008
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Universidade Federal do Rio de Janeiro, Rio De Janeiro, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
  • Enrollment - 500
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Orotracheal intubation rate|Hospitalisation days|ICU days|Intranasal oxygen support days|Mortality rate|Days with fever|Days with cough|Days with dyspnea|Radiologic findings|Cardiologic findings|C-reactive protein - absolute number|C-reactive protein serum levels|Lactate dehydrogenase (LDH) serum levels|Troponin serum levels|Electrolytes serum levels|Glucose serum levels|Renal function|Coagulogram|Liver function panel|Ferritin|D-dimer|Blood cell count|Inflammatory mediators
NCT04363606 Chronic Fatigue Etiology and Recovery in Covid-19 Patients: the Role of Fatigability Recruiting Not Applicable May/27/2020 Dec/01/2022
  • Alternative id - 20CH085|2020-A00982-37
  • Interventions - Other: Questionnaires|Biological: blood test|Other: Maximal effort test|Device: actigraphy|Device: Neuromuscular evaluation|Other: stool analysis|Other: food diary
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - CHU de Grenoble, Grenoble, France|Clinique de la Sauvegarde - Lyon, Lyon, France|Hôpital Croix Rousse - HCL, Lyon, France|Centre Hospitalier de Lyon Sud, Pierre-benite, France|Chu Saint-Etienne, Saint Etienne, France|Clinique Mutualiste Saint Etienne, Saint Etienne, France|Hôpital Henry Gabrielle, Saint-Genis-Laval, France|Hôpital privé de la Loire, Saint-Étienne, France
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Diagnostic
  • Enrollment - 102
  • Age - 35 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - voluntary maximum force reduction|Neuromuscular function : cortical activity|Neuromuscular function : Peripheral function|Maximal oxygen uptake (VO2max)|quality of sleep|muscle volume|metabolic fatigue|microbiote intestinal
NCT04359680 Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection Active, not recruiting Phase 3 May/13/2020 Mar/29/2021
  • Alternative id - RM08-3007
  • Interventions - Drug: Nitazoxanide|Drug: Placebo|Dietary Supplement: Vitamin Super B-Complex
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - HealthStar Research LLC, Hot Springs, Arkansas, United States|So Cal Clinical Research, Huntington Beach, California, United States|Long Beach Clinical Trials, LLC, Long Beach, California, United States|Meris Clinical Research, Brandon, Florida, United States|Invesclinica US LLC, Fort Lauderdale, Florida, United States|The Chappel Group Research, Kissimmee, Florida, United States|New Horizon Research Center, Miami, Florida, United States|Clinical Neuroscience Solutions, Inc., Orlando, Florida, United States|DMI Research, Pinellas Park, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Chicago Clinical Research Institute, Inc., Chicago, Illinois, United States|Chicago Medical Research Institute, Inc., Chicago, Illinois, United States|Quad Clinical Research, Chicago, Illinois, United States|Chicago Medical Research, LLC, Hazel Crest, Illinois, United States|Centex Studies, Inc., Lake Charles, Louisiana, United States|Vida Clinical Studies, Dearborn, Michigan, United States|Beacom Family Health Connection, Fremont, Nebraska, United States|North Jersey Community Research Initiative, Newark, New Jersey, United States|RH Medical Urgent Care Professional PLLC, Bronx, New York, United States|Integrative Clinical Trials LLC, Brooklyn, New York, United States|The New York Center for Travel and Tropical Medicine, New York, New York, United States|Centex Studies, Inc., Houston, Texas, United States|SMS Clinical Research LLC, Mesquite, Texas, United States|LinQ Research LLC, Pearland, Texas, United States|Rio Grande Valley Clinical Research Institute, Pharr, Texas, United States|BFHC Research, San Antonio, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 1407
  • Age - 18 Years to 120 Years   (Adult, Older Adult)
  • Outcome measures - The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.|The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.
NCT04382846 Novel Regimens in COVID-19 Treatment Recruiting Phase 3 May/08/2020 Dec/01/2030
  • Alternative id - tanta covid treatment
  • Interventions - Drug: Nitazoxanide
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Tanta University, Assiut University, Tanta, Egypt|Sherief Abd-Elsalam, Tanta, Egypt
  • 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 - Number of patients with virological cure
NCT04406246 Prevention of Coronavirus Disease (COVID-19) Outbreaks With Nitazoxanide Completed Phase 4 May/21/2020 Dec/31/2020
  • Alternative id - 2020-04-682
  • Interventions - Drug: Nitazoxanide 500Mg Oral Tablet
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Materno-Perinatal Hospital "Mónica Pretelini", Toluca, Mexico
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 150
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Health workers that require hospitalization
NCT04532931 COVID-19 Treatment in South Africa Completed Phase 2 Sep/03/2020 Aug/23/2021
  • Alternative id - SP-PA-COV-202
  • Interventions - Other: Standard of care (Paracetamol)|Drug: Artesunate-amodiaquine|Drug: Pyronaridine-artesunate|Drug: Favipiravir plus Nitazoxanide|Drug: Sofosbuvir/daclatasvir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand, Johannesburg, South Africa
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 192
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Incidence of SARS-CoV-2 clearance|Time to clearance of nasal SARS-CoV-2|Median quantity of SARS-CoV-2|Proportion of days with fever after randomization|Proportion of days with respiratory symptoms after randomization|FLU-PRO© Plus|Serious adverse events|Adverse events resulting in treatment discontinuation|Adverse events considered related to the investigational products|LRTI|Maximum score on WHO Ordinal Scale for Clinical Improvement during study participation|Cumulative incidence of hospitalization|Days of hospitalization|Cumulative incidence of mortality
NCT04918927 Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19 Recruiting Phase 2 Oct/12/2021 Mar/01/2022
  • Alternative id - 2021-785-018
  • Interventions - Drug: Favipiravir|Drug: Nitazoxanide|Other: Nitazoxanide Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital de Infectología "Daniel Méndez Hernández" del Centro Médico Nacional La Raza, Ciudad de Mexico, Azcapotzalco, Mexico
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 120
  • Age - 18 Years to 70 Years   (Adult, Older Adult)
  • Outcome measures - Upper respiratory tract viral load at Day 5.|Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy|Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation.|Rate of decrease in upper respiratory tract viral load during 7 days of therapy.|Duration of fever following commencement of medication|Proportion of participants with hepatotoxicity after 7day of therapy and 14 days post-randomisation.|Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation.|Proportion of participants admitted to hospital with COVID-19 related illness.|Proportion of participants admitted to ICU with COVID-19 related illness.|Proportion of participants who have died with COVID-19 related illness|Pharmacokinetic analysis of favipiravir and tizoxanide: Clearance (CL)|Pharmacokinetic analysis of favipiravir and tizoxanide: Volume of distribution (V)|Pharmacokinetic analysis of favipiravir and tizoxanide: Absorption rate constant (Ka)|Pharmacokinetic analysis of favipiravir and tizoxanide: Maximum concentration (Cmax)|Pharmacokinetic analysis of favipiravir and tizoxanide: Time to maximum concentration (Tmax)|Pharmacokinetic analysis of favipiravir and tizoxanide: Elimination rate constant (Ke)|Pharmacokinetic analysis of favipiravir and tizoxanide: Area Under the Curve extrapolated to infinity (AUC 80-inf).|Pharmacodynamic analysis of favipiravir and tizoxanide: Rate of viral load decline (delta)|Pharmacodynamic analysis of favipiravir and tizoxanide: Maximum increase in viral load under drug treatment (Emax).|Pharmacodynamic analysis of favipiravir and tizoxanide: Concentration to achieve half the maximum possible effects (EC50)|Exploratory: proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2.
NCT04360356 Ivermectin and Nitazoxanide Combination Therapy for COVID-19 Not yet recruiting Phase 2|Phase 3 May/01/2020 Dec/01/2020
  • Alternative id - IVR/NTZ
  • Interventions - Combination Product: Ivermectin plus Nitazoxanide|Other: Standard Care
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Number of Patients with COVID-19-negative PCR|Number of patients with improved respiratory rate|Number of patients with improved PaO2|Number of patients with normalized Serum IL6|Number of patients with normalized Serum TNFα|Number of patients with normalized Serum iron|Number of patients with normalized Serum ferritin|Number of patients with normalized International normalized ratio "INR" for prothrombin time|Number of patients with normalized complete blood count "CBC"|The Mortality rate among treated patients
NCT04920838 Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection Recruiting Phase 2|Phase 3 Apr/12/2021 Dec/01/2021
  • Alternative id - ANRS COV33 COVERAGE-Africa
  • Interventions - Drug: Nitazoxanide and Ciclésonide|Drug: Telmisartan 20Mg Oral Tablet|Drug: Paracetamol
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Centre Muraz/INSP, Bobo-Dioulasso, Burkina Faso|Centre de traitement des maladies à tendance épidémique de Gbessia, Conakry, Guinea
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 600
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - SpO2 ≤ 93% within 14 days|Death within 14 days|Death within 28 days|Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days|Number of hospitalizations due to severe progression
NCT04392427 New Antiviral Drugs for Treatment of COVID-19 Not yet recruiting Phase 3 Oct/01/2020 May/01/2022
  • Alternative id - 20.05.69
  • Interventions - Drug: Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days :
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Mansoura University, Mansoura, Select A State Or Province, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - 12 Years and older   (Child, Adult, Older Adult)
  • Outcome measures - negative test result for COVID-19
NCT04435314 Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 Not yet recruiting Phase 2 Jun/01/2020 Aug/01/2020
  • Alternative id - NITFQM0620OR
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • 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: Prevention
  • Enrollment - 200
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study|Incidence of Treatment-Emergent Adverse Events|The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study|The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study|Treatment adherence|Disease complication|Incidence of subjects that underwent unscheduled visit
NCT04423861 Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19 Not yet recruiting Phase 3 Dec/01/2020 May/01/2021
  • Alternative id - NITFQM0920OR-III
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • 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 - 380
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Need of mechanical ventilation|Change in the pulmonary condition|Change in Clinical Condition|Change in tomographic pulmonary condition|Rate of mortality within 14-days|Change in inflammatory markers
NCT04343248 Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF) Active, not recruiting Phase 3 May/12/2020 Jun/30/2021
  • Alternative id - RM08-3006
  • Interventions - Drug: Nitazoxanide|Drug: Placebo|Dietary Supplement: Vitamin Super B-Complex
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - The Chappel Group Research, Kissimmee, Florida, United States|Clinical Trial Specialists, Inc., Acworth, Georgia, United States|Centex Studies, Inc., Lake Charles, Louisiana, United States|Centex Studies, Inc., Houston, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
  • Enrollment - 800
  • Age - 55 Years to 120 Years   (Adult, Older Adult)
  • Outcome measures - Symptomatic laboratory-confirmed COVID-19|Symptomatic laboratory-confirmed VRI
NCT04746183 AGILE (Early Phase Platform Trial for COVID-19) Recruiting Phase 1|Phase 2 Jul/03/2020 Apr/30/2022
  • Alternative id - UoL001542
  • Interventions - Drug: CST-2: EIDD-2801|Drug: CST-2: Placebo|Drug: Nitazoxanide|Drug: VIR-7832|Drug: VIR-7831|Drug: CST-5: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Desmond Tutu Health Foundation, Cape Town, South Africa|Ezintsha, Johannesburg, South Africa|Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom|Kings College Hospital NHS Foundation Trust, London, United Kingdom|Manchester University NHS Foundation Trust, Manchester, United Kingdom|University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 600
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Master Protocol: Dose-finding/Phase I|Master Protocol: Efficacy evaluation/Phase II - Severe patients (Group A)|Master Protocol: Efficacy evaluation/Phase II - Mild to moderate patients (Group B)|CST-2 Phase I: To determine the safety and tolerability of multiple ascending doses of EIDD-2801 to recommend dose for phase II.|CST-2 Phase II: To determine the ability of EIDD-2801 to reduce serious complications of COVID-19 including hospitalization, reduction in SAO2<92%, or death.|Master Protocol: Safety assessed by rate of adverse events|Master Protocol: To evaluate clinical improvement|Master Protocol: To evaluate clinical improvement using WHO clinical progression scale|Master Protocol: To evaluate clinical improvement using SpO2/FiO2|Master Protocol: To evaluate discharge|Master Protocol: To evaluate admission to ICU|Master Protocol: To evaluate safety further (WCC)|Master Protocol: To evaluate safety further (Hg)|Master Protocol: To evaluate safety further (platelets)|Master Protocol: To evaluate safety further (creatinine)|Master Protocol: To evaluate safety further (ALT)|Master Protocol: To evaluate overall mortality|Master Protocol: To evaluate the number of oxygen-free days|Master Protocol: To evaluate ventilator-free days|Master Protocol: To evaluate incidence of new mechanical ventilation use|Master Protocol: To evaluate National Early Warning Score (NEWS)2/qSOFA|Master Protocol: To evaluate translational outcomes (Viral Load)|Master Protocol: To evaluate translational outcomes (Baseline SARS-COV-2)|CST-2 Additional: Pharmacokinetic Objective: To define PK of EIDD-2801 and EIDD-1931 in plasma following multiple doses administered to patients with COVID-19.|CST-2 Additional: Virologic Objective: To assess the difference in viral clearance (time to negative PCR) between EIDD-2801 and control.|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (FLU-PRO)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (WHO Scale).|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (NEWS2)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (mortality)|CST-2 Additional: Clinical Objective: To determine the ability of EIDD-2801 to reduce the duration of signs and symptoms of COVID-19 in patients (death)
NCT04552483 Effects of Early Use of Nitazoxanide in Patients With COVID-19 Completed Phase 2 Jun/08/2020 Sep/05/2020
  • Alternative id - SARITA-2|RBR-4nr86m|32258920.0.1001.5257
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Universidade Federal do Rio de Janeiro, Rio De Janeiro, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
  • Enrollment - 392
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Days with fever|Days with cough|Days with asthenia|SARS-COV-2 viral load - absolute number|SARS-COV-2 viral load - percentage|Hospital admission rate - absolute number|Hospital admission rate - percentage|Serum Interleukin-6|Serum Interleukin-1-beta|Serum Interleukin-8|Serum tumor necrosis factor (TNF)-alfa|Serum interferon-gamma|Serum monocyte chemoattractant protein (MCP)-1|Complete blood count|C-reactive protein - absolute number|C-reactive protein - percentage
NCT04361318 Hydroxychloroquine and Nitazoxanide Combination Therapy for COVID-19 Not yet recruiting Phase 2|Phase 3 May/01/2020 Dec/01/2020
  • Alternative id - HCQ/NTZ
  • Interventions - Combination Product: Hydroxychloroquine plus Nitazoxanide|Other: Standard care
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
  • Enrollment - 100
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Number of patients with COVID-19-negative PCR|Number of patients with improved respiratory rate|Number of patients with improved PaO2|Number of patients with normalized Serum IL6|Number of patients with normalized Serum TNFα|Number of patients with normalized Serum iron|Number of patients with normalized Serum ferritin|Number of patients with normalized International normalized ratio "INR" for prothrombin time|Number of patients with normalized complete blood count "CBC"|The Mortality rate among treated patients
NCT04788407 Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts Recruiting Phase 4 Dec/01/2020 Apr/30/2022
  • Alternative id - FH-53
  • Interventions - Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Fundación Huésped., Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 456
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study|Proportion of adverse events (AE) and serious AE (SAE) related to research product.|Incidence of all causes of study drug withdrawal or discontinuation.
NCT04729491 EAT-DUTA AndroCoV Trial Completed Phase 2|Phase 3 Jun/30/2020 Oct/07/2020
  • Alternative id - CORPO-AB-DRUG-SARS-004B
  • Interventions - Drug: Dutasteride 0.5 mg|Drug: Azithromycin|Drug: Nitazoxanide|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Corpometria Institute, Brasília, DF, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 138
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis)|World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death]|World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death]|Time-to-recovery|SARS-CoV-2 viral load|Duration of fatigue|Duration of anosmia|Overall duration of clinical manifestations|Proportion of subjects needing additional drugs or interventions|Proportion of subjects needing oxygen use|Proportion of subjects needing high-flow oxygen therapy or non-invasive ventilation|Proportion of hospitalizations|Proportion of mechanical ventilation use|Proportion of vasopressors use|Proportion of deaths|Duration of new oxygen use|Duration of hospitalization|Duration of mechanical ventilation|Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)|Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))|Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))|Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)|Variation in oxygen saturation compared to baseline (Day 0)|Disease duration|Change in viral load from baseline to Day 5|Proportion of post-COVID mental symptoms|Proportion of post-COVID physical symptoms|Proportion of post-COVID overall symptoms
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