Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
NCT ID: NCT04858425
Last Updated: 2024-10-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
166 participants
INTERVENTIONAL
2021-04-30
2023-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
Placebo
Matching placebo tablets 3 times daily for 14 days
Placebo
Matched placebo tablets 400 mg 3 times daily for 14 days
Interventions
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Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
Placebo
Matched placebo tablets 400 mg 3 times daily for 14 days
Eligibility Criteria
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Inclusion Criteria
2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.
Exclusion Criteria
2. Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion.
3. Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.
18 Years
ALL
No
Sponsors
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Entero Therapeutics
INDUSTRY
Responsible Party
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Locations
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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"
Kremenchuk, Poltava Oblast, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AZ-NICL-COV-1
Identifier Type: -
Identifier Source: org_study_id
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