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NCT04753619
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Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management |
Recruiting |
Phase 2 |
Jan/03/2021 |
Dec/03/2021 |
- Alternative id - PRO2021070003
- Interventions - Drug: Niclosamide Oral Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Ahmed S. Abdulamir, Baghdad, Baghdada, Iraq
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of Cure of the patient|Time to recovery|The percentage of Progressive patients|Rate of mortality|Side effects
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NCT04644705
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Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat |
Completed |
Phase 1 |
Nov/02/2020 |
May/03/2021 |
- Alternative id - 201767
- Interventions - Drug: Niclosamide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Charité Research Organisation GmbH, Berlin, Germany
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 28
- Age - 18 Years to 45 Years (Adult)
- Outcome measures - Treatment emergent number of Adverse Events|Maximum plasma concentration of niclosamide (µg/ml)|Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide(AUC0-last) of niclosamide [µg/ml*h]|Food effect on maximum plasma concentration of niclosamide (µg/ml)|Food effect on Area Under the Plasma Concentration Time Curve from predose until last detectable concentration of niclosamide (AUC0-last) [µg/ml*h]|Maximum plasma concentration of niclosamide (µg/ml) at steady state after multiple dosing|Area Under the Plasma Concentration Time Curve between two dosing intervals (AUC tau ss) of niclosamide [µg/ml*h] at steady state after multiple dosing
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NCT04750759
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Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat |
Terminated |
Phase 2 |
Feb/03/2021 |
Oct/29/2021 |
- Alternative id - 201741
- Interventions - Drug: Niclosamide + Camostat|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Charité Research Organisation GmbH, Berlin, Germany
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 4
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Treatment emergent number of Adverse Events
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NCT04749173
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To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers. |
Completed |
Phase 1 |
Nov/21/2020 |
Jun/18/2021 |
- Alternative id - DW_DWJ1516101
- Interventions - Drug: DWRX2003, 96mg|Drug: DWRX2003, 432mg|Drug: DWRX2003, 144mg
- Study type - Interventional
- Study results - No Results Available
- Locations - Chungnam National university hospital, Daejeon, Korea, Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 19 Years to 55 Years (Adult)
- Outcome measures - Incidence of Treatment-Emergent Adverse Events
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NCT04870333
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PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V |
Recruiting |
Phase 2|Phase 3 |
Feb/19/2021 |
Oct/01/2024 |
- Alternative id - CCTU0307|2020-004144-28
- Interventions - Drug: Niclosamide|Drug: Placebo|Drug: Ciclesonide|Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom|Betsi Cadwaladr University Health Board, Bodelwyddan, United Kingdom|Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom|North Bristol NHS Trust, Bristol, United Kingdom|East Kent Hospitals University NHS Foundation Trust, Canterbury, United Kingdom|Cardiff & Vale University Health Board, Cardiff, United Kingdom|Epsom and St Helier University Hospitals NHS Trust, Carshalton, United Kingdom|Ayrshire & Arran NHS Trust, Crosshouse, United Kingdom|Dartford and Gravesham NHS Trust, Dartford, United Kingdom|University Hospitals of Derby and Burton NHS Trust, Derby, United Kingdom|Dorset County Hospital NHS Foundation Trust, Dorchester, United Kingdom|NHS Tayside, Dundee, United Kingdom|The Royal Devon and Exeter NHS Foundation Trust, Exeter, United Kingdom|James Paget University Hospital NHS Foundation Trust, Great Yarmouth, United Kingdom|Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom|Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust, King's Lynn, United Kingdom|University Hospitals of Leicester NHS Trust, Leicester, United Kingdom|Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, United Kingdom|Barts Health NHS Trust, London, United Kingdom|Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom|Imperial College Healthcare NHS Trust, London, United Kingdom|King's College Hospital NHS Foundation Trust, London, United Kingdom|Royal Free NHS Foundation Trust, London, United Kingdom|St George's University Hospitals NHS Foundation Trust, London, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom|Royal Berkshire NHS Foundation, Reading, United Kingdom|Salford Royal NHS Foundation, Salford, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom|East and North Hertfordshire NHS Trust, Stevenage, United Kingdom|South Tyneside and Sunderland NHS Foundation Trust, Sunderland, United Kingdom|Wirral University Teaching Hospital NHS Foundation Trust, Wirral, United Kingdom|The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom|York Teaching Hospital NHS Foundation Trust, York, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 5000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Confirmed symptomatic COVID-19 infection during treatment|Time to confirmed SARS-Cov-2 infection from the date of randomisation including asymptomatic cases|Safety|All-cause mortality|Severity of COVID-19 disease
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NCT04399356
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Niclosamide for Mild to Moderate COVID-19 |
Completed |
Phase 2 |
Oct/01/2020 |
Aug/19/2021 |
- Alternative id - STUDY00000605
- Interventions - Drug: Niclosamide|Drug: Placebo|Other: Telehealth monitoring
- Study type - Interventional
- Study results - No Results Available
- Locations - Tufts Medical Center, Boston, Massachusetts, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 73
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change in respiratory viral clearance (by PCR)|Fecal viral clearance (by PCR)|Reduction (change) in respiratory viral shedding (by PCR)|Reduction (change) in GI viral shedding (by PCR)|Progression to severe COVID-19 Disease|Time to resolution of a fever
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NCT04436458
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Niclosamide In Moderate COVID-19 |
Withdrawn |
Phase 2 |
Jan/20/2022 |
Jan/20/2022 |
- Alternative id - FW-COV-002
- Interventions - Drug: Niclosamide Oral Tablet|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 - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group
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NCT05087381
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Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community |
Recruiting |
Phase 4 |
Oct/01/2021 |
Apr/30/2022 |
- Alternative id - 64197
- Interventions - Drug: FluvoxaMINE Maleate 50 MG|Combination Product: Fluvoxamine, Bromhexine|Combination Product: Fluvoxamine, Cyproheptadine|Drug: Niclosamide Pill|Combination Product: Niclosamide, Bromhexine
- Study type - Interventional
- Study results - No Results Available
- Locations - Rajvithi Hospital, Ratchathewi, Bangkok, Thailand|Chiangmai Neurological Hospital, Chiangmai, Thailand
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1800
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Hospital admission or mortality related to COVID-19|Time taken to self- report recovery|Progression to severe COVID-19 Disease|Reduction (change) in GI viral shedding (by PCR)|Change in respiratory viral clearance (by PCR)|Time to resolution of a fever|Negative effects on well being
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NCT04603924
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Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients |
Recruiting |
Phase 2|Phase 3 |
Oct/07/2020 |
Jun/01/2022 |
- Alternative id - ANA001-001
- Interventions - Drug: Niclosamide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Helen Keller Hospital, Sheffield, Alabama, United States|Baptist Health Research Institute, Jacksonville, Florida, United States|AdventHealth Tampa, Tampa, Florida, United States|University of Missouri Health Care, Columbia, Missouri, United States|Therapeutic Concepts, PA, Houston, Texas, United States|Memorial Hermann Memorial City Medical Center, Houston, Texas, United States|Memorial Hermann Southeast Hospital, Houston, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 436
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Safety and Tolerability of ANA001 as measured by the incidence of treatment emergent adverse events (TEAE's) (Part 1 and Part 2)|Efficacy as measured by median time to hospital discharge (Part 2)|Efficacy as measured by median time to hospital discharge (Part 1)|Pharmacokinetics (PK) of ANA001 as measured by plasma concentrations (Part 1)|Efficacy of ANA001 as measured by mean change from baseline in the National Early Warning Score (NEWS 2) (Part 2)|Efficacy of ANA001 as measured by mean number of days on rescue therapy (Part 2)
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NCT04542434
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Niclosamide in COVID-19 |
Withdrawn |
Phase 2 |
Jan/20/2022 |
Jan/20/2022 |
- Alternative id - FW-COV-003
- Interventions - Drug: Niclosamide Oral Tablet|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 - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Mortality|TEAE|SAEs|Safety laboratory|Blood pressure|fecal RNA virus clearance|Body temperature|Heart rate|SaO2|ECG
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NCT04858425
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Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection |
Active, not recruiting |
Phase 2 |
Apr/30/2021 |
Mar/01/2022 |
- Alternative id - AZ-NICL-COV-1
- Interventions - Drug: Niclosamide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Central Alabama Research, Birmingham, Alabama, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States|New Generation Medical Research, Hialeah, Florida, United States|LCC Medical Reserach Institute, LLC, Miami, Florida, United States|Westchester General Hospital, Miami, Florida, United States|Miami Clinical Research, Miami, Florida, United States|P & S Research, LLC, Miami, Florida, United States|University of South Florida, Tampa, Florida, United States|IACT Health - Roswell, Columbus, Georgia, United States|Snake River Research, PLLC, Idaho Falls, Idaho, United States|Homestead Associates in Research, Homestead Meadows, Texas, United States|SMS Clinical Research LLC, Mesquite, Texas, United States|Tranquil Research, Webster, Texas, United States|Yashoda Hospital, Secunderabad, Andhra Pradesh, India|SSG Hospital and Medical Institute, Vadodara, Gujarat, India|GMERS Medical College and Hospital, Vadodara, Gujarat, India|Noble Hospital Private Limited, Pune, Maharashtra, India|Sir Ganga Ram Hospital, Nagar, New Delhi, India|Maharaja Agrasen Superspeciality Hospital, Jaipur, Jaipur, Rajasthan, India|Malla Reddy Narayana Multispecialty Hospital, Hyderabad, Telangana, India|Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska", Kremenchug, Poltava, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council, Dnipro, Ukraine|Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Ukraine|Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council, Kharkiv, Ukraine|Private Enterprise Private Manufacturing Company Acinus, Kropyvnytskyi, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 166
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - SAEs|TEAE|Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes|Fecal RNA virus Clearance|Clinical Severity Score|Time to Resolution of Diarrhea
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NCT04558021
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A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19 |
Recruiting |
Phase 3 |
Oct/08/2020 |
Feb/14/2021 |
- Alternative id - NOV2020/01930
- Interventions - Drug: Niclosamide suspension|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Akdeniz Üniversitesi Tıp Fakültesi Hastanesi, Antalya, Turkey|Antalya Eğitim ve Araştırma Hastanesi, Antalya, Turkey|Gaziantep Üniversitesi Tıp Fakültesi Hastanesi, Gaziantep, Turkey|Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi, Istanbul, Turkey|Dokuz Eylül Üniversitesi Hastanesi, İzmir, Turkey|İzmir SBÜ Tepecik Eğitim ve Araştırma Hastanesi, İzmir, Turkey|SBÜ Dr. Suat Seren Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi, İzmir, Turkey|İzmir Katip Çelebi Üniversitesi Atatürk Eğitim ve Araştırma Hastanesi, İzmir, Turkey
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Physician's judgment on clinical recovery from the time of admission|Clinical improvement in NEWS2|Improvement in serum biomarkers|Requirement for indotracheal intubation|Occurrence of Macrophage Activation Syndrome(MAS)|Occurrence of Coagulopathy
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NCT04932915
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Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19 |
Terminated |
Phase 2 |
Sep/03/2021 |
Jan/10/2022 |
- Alternative id - UNI91103-201|2021-001036-25
- Interventions - Drug: Niclosamide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Klinische Forschung Berlin-Mitte GmbH, Berlin, Germany|Klinische Forschung Dresden GmbH, Dresden, Germany|Klinische Forschung Hamburg GmbH, Hamburg, Germany
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 4
- Age - 45 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Proportion of subjects with worsened symptoms any time from Day 3 to Day 10 compared with baseline|Proportion of subjects with worst intensity/grade up to Day 10 and up to Day 15 in any single symptoms in the 3 domains of the FDA COVID-19 questionnaire|Proportion of subjects reporting the following number of symptoms with worst intensity/severe grade: ≥ 1 symptom, ≥ 2 symptoms, ≥ 3 symptoms, etc.|Proportion of subjects with worsened symptoms at Day 15 compared with baseline.|Change from baseline in each single symptom score|Proportion of subjects who are asymptomatic on Day 10|Proportion of subjects requiring visits to urgent care (UC) or emergency department (ED) facilities, or hospitalization because of signs or symptoms of COVID-19|Proportion of subjects admitted to intensive care units (ICU) and/or died|Change from baseline in SARS-CoV-2 viral load at Day 5 and Day 10
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NCT04576312
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Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers |
Completed |
Phase 1 |
Jun/29/2020 |
Dec/04/2020 |
- Alternative id - UNI911-101|2020-002049-40
- Interventions - Drug: UNI911 inhalation 1% and intranasal spray 1%|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - DanTrials ApS, Copenhagen, Denmark
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Other
- Enrollment - 64
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency
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NCT04372082
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Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19 |
Withdrawn |
Phase 3 |
May/01/2020 |
May/01/2023 |
- Alternative id - 2020_40|2020-002188-72
- Interventions - Other: Standard of care (SOC)|Drug: Hydroxychloroquine|Drug: Association of diltiazem and niclosamide
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Investigator)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - death|clinical worsening (composite criteria)|Assisted-ventilation and/or hospitalization (composite criteria)|National Early Warning Score (NEWS)|cumulative incidence of hospitalizations|cumulative incidence of the use of oxygen therapy, non-invasive ventilation or invasive ventilation ( composite criteria)|Mortality|cumulative incidence of viral shedding on SARS-CoV-2 rt-PCR on nasopharyngeal swab;|adverse drug reactions
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