Back to resultsSafety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (RESERVOIR)
Primary Purpose
Covid19
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Niclosamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring SARS-CoV-2, Covid, Covid19 Diarrhea, Covid19 GI Infection
Eligibility 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.
Sites / Locations
- Central Alabama Research
- Midland Florida Clinical Research Center, LLC
- New Generation Medical Research
- LCC Medical Reserach Institute, LLC
- Westchester General Hospital
- Miami Clinical Research
- P & S Research, LLC
- University of South Florida
- IACT Health - Roswell
- Snake River Research, PLLC
- Homestead Associates in Research
- SMS Clinical Research LLC
- Tranquil Research
- Yashoda Hospital
- SSG Hospital and Medical Institute
- GMERS Medical College and Hospital
- Noble Hospital Private Limited
- Sir Ganga Ram Hospital
- Maharaja Agrasen Superspeciality Hospital, Jaipur
- Malla Reddy Narayana Multispecialty Hospital
- Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"
- Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
- Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
- Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council
- Private Enterprise Private Manufacturing Company Acinus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Niclosamide
Placebo
Arm Description
Niclosamide tablets 400 mg 3 times daily for 14 days
Matching placebo tablets 3 times daily for 14 days
Outcomes
Primary Outcome Measures
SAEs
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
TEAE
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.
Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes
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
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
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
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).
Full Information
NCT ID
NCT04858425
First Posted
April 21, 2021
Last Updated
April 5, 2023
Sponsor
First Wave BioPharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04858425
Brief Title
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Acronym
RESERVOIR
Official Title
A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
June 4, 2022 (Actual)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Wave BioPharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, Covid, Covid19 Diarrhea, Covid19 GI Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niclosamide
Arm Type
Experimental
Arm Description
Niclosamide tablets 400 mg 3 times daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets 3 times daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
Niclosamide tablets 400 mg 3 times daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo tablets 400 mg 3 times daily for 14 days
Primary Outcome Measure Information:
Title
SAEs
Description
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
Time Frame
Day 1 to 6 weeks
Title
TEAE
Description
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.
Time Frame
Day 1 to 6 weeks
Title
Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes
Description
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.
Time Frame
Day 1 to Day 43
Title
Fecal RNA virus Clearance
Description
Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.
Time Frame
Day 1 to 6 weeks
Secondary Outcome Measure Information:
Title
Clinical Severity Score
Description
Proportion of patients with each clinical severity score as recommended by the World Health Organization (WHO) for COVID-19 studies by study visit;
Time Frame
Day 1 to 6 weeks
Title
Time to Resolution of Diarrhea
Description
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).
Time Frame
Day 1 to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0920
Country
United States
Facility Name
New Generation Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1895
Country
United States
Facility Name
LCC Medical Reserach Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Westchester General Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-2805
Country
United States
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
P & S Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175-2912
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
IACT Health - Roswell
City
Columbus
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Homestead Associates in Research
City
Homestead Meadows
State/Province
Texas
ZIP/Postal Code
33032-8225
Country
United States
Facility Name
SMS Clinical Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Tranquil Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Yashoda Hospital
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
50003
Country
India
Facility Name
SSG Hospital and Medical Institute
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
GMERS Medical College and Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Facility Name
Noble Hospital Private Limited
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
Sir Ganga Ram Hospital
City
Nagar
State/Province
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Maharaja Agrasen Superspeciality Hospital, Jaipur
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302039
Country
India
Facility Name
Malla Reddy Narayana Multispecialty Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500055
Country
India
Facility Name
Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"
City
Kremenchug
State/Province
Poltava
ZIP/Postal Code
39600
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
41102
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council
City
Ivano-Frankivsk
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company Acinus
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
We'll reach out to this number within 24 hrs