RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

Sponsor
First Wave Bio, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04858425
Collaborator
(none)
166
25
2
14
6.6
0.5

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

Study Type:
Interventional
Actual Enrollment :
166 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 30, 2021
Actual Primary Completion Date :
Jan 6, 2022
Anticipated Study Completion Date :
Jul 1, 2022

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

  1. 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).

  2. TEAE [Day 1 to 6 weeks]

    Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.

  3. 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.

  4. 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

  1. 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;

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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.

  2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

Exclusion Criteria:
  1. 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.

  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.

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.
Responsible Party:
First Wave Bio, Inc.
ClinicalTrials.gov Identifier:
NCT04858425
Other Study ID Numbers:
  • AZ-NICL-COV-1
First Posted:
Apr 26, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by First Wave Bio, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022