RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Study Details
Study Description
Brief Summary
This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Niclosamide Niclosamide tablets 400 mg 3 times daily for 14 days |
Drug: Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo Comparator: Placebo Matching placebo tablets 3 times daily for 14 days |
Drug: Placebo
Matched placebo tablets 400 mg 3 times daily for 14 days
|
Outcome Measures
Primary Outcome Measures
- SAEs [Day 1 to 6 weeks]
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
- TEAE [Day 1 to 6 weeks]
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.
- Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes [Day 1 to Day 43]
Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
- Fecal RNA virus Clearance [Day 1 to 6 weeks]
Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.
Secondary Outcome Measures
- Clinical Severity Score [Day 1 to 6 weeks]
Proportion of patients with each clinical severity score as recommended by the World Health Organization (WHO) for COVID-19 studies by study visit;
- Time to Resolution of Diarrhea [Day 1 to 6 weeks]
Time from the first dose of study treatment to the last loose or watery stool in patients with loose or watery stool (Bristol Stool Scale Types 5-7).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Part 1 only, patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures.
-
Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.
Exclusion Criteria:
-
At the time of randomization, patients who require intensive care unit (ICU) admission or patients with severe respiratory insufficiency who require mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
-
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.
-
Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Central Alabama Research | Birmingham | Alabama | United States | 35209 |
2 | Midland Florida Clinical Research Center, LLC | DeLand | Florida | United States | 32720-0920 |
3 | New Generation Medical Research | Hialeah | Florida | United States | 33016-1895 |
4 | LCC Medical Reserach Institute, LLC | Miami | Florida | United States | 33126 |
5 | Westchester General Hospital | Miami | Florida | United States | 33155-2805 |
6 | Miami Clinical Research | Miami | Florida | United States | 33155 |
7 | P & S Research, LLC | Miami | Florida | United States | 33175-2912 |
8 | University of South Florida | Tampa | Florida | United States | 33606 |
9 | IACT Health - Roswell | Columbus | Georgia | United States | 30076 |
10 | Snake River Research, PLLC | Idaho Falls | Idaho | United States | 83404 |
11 | Homestead Associates in Research | Homestead Meadows | Texas | United States | 33032-8225 |
12 | SMS Clinical Research LLC | Mesquite | Texas | United States | 75149 |
13 | Tranquil Research | Webster | Texas | United States | 77598 |
14 | Yashoda Hospital | Secunderabad | Andhra Pradesh | India | 50003 |
15 | SSG Hospital and Medical Institute | Vadodara | Gujarat | India | 390001 |
16 | GMERS Medical College and Hospital | Vadodara | Gujarat | India | 390021 |
17 | Noble Hospital Private Limited | Pune | Maharashtra | India | 411013 |
18 | Sir Ganga Ram Hospital | Nagar | New Delhi | India | 110060 |
19 | Maharaja Agrasen Superspeciality Hospital, Jaipur | Jaipur | Rajasthan | India | 302039 |
20 | Malla Reddy Narayana Multispecialty Hospital | Hyderabad | Telangana | India | 500055 |
21 | Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska" | Kremenchug | Poltava | Ukraine | 39600 |
22 | Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council | Dnipro | Ukraine | 41102 | |
23 | Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council | Ivano-Frankivsk | Ukraine | 76025 | |
24 | Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council | Kharkiv | Ukraine | 61124 | |
25 | Private Enterprise Private Manufacturing Company Acinus | Kropyvnytskyi | Ukraine | 25006 |
Sponsors and Collaborators
- First Wave Bio, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AZ-NICL-COV-1