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

Covid19 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04858425
• Other study ID #: AZ-NICL-COV-1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 30, 2021
• Est. completion date: May 2023

Study information

• Verified date: April 2023
• Source: First Wave BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: May 2023
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Infections

Intervention

Drug:
• Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
• Placebo
Matched placebo tablets 400 mg 3 times daily for 14 days

Locations

Country	Name	City	State
India	Malla Reddy Narayana Multispecialty Hospital	Hyderabad	Telangana
India	Maharaja Agrasen Superspeciality Hospital, Jaipur	Jaipur	Rajasthan
India	Sir Ganga Ram Hospital	Nagar	New Delhi
India	Noble Hospital Private Limited	Pune	Maharashtra
India	Yashoda Hospital	Secunderabad	Andhra Pradesh
India	GMERS Medical College and Hospital	Vadodara	Gujarat
India	SSG Hospital and Medical Institute	Vadodara	Gujarat
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	Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"	Kremenchug	Poltava
Ukraine	Private Enterprise Private Manufacturing Company Acinus	Kropyvnytskyi
United States	Central Alabama Research	Birmingham	Alabama
United States	IACT Health - Roswell	Columbus	Georgia
United States	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	New Generation Medical Research	Hialeah	Florida
United States	Homestead Associates in Research	Homestead Meadows	Texas
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	SMS Clinical Research LLC	Mesquite	Texas
United States	LCC Medical Reserach Institute, LLC	Miami	Florida
United States	Miami Clinical Research	Miami	Florida
United States	P & S Research, LLC	Miami	Florida
United States	Westchester General Hospital	Miami	Florida
United States	University of South Florida	Tampa	Florida
United States	Tranquil Research	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
First Wave BioPharma, Inc.

Countries where clinical trial is conducted

United States,  India,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAEs	Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).	Day 1 to 6 weeks
Primary	TEAE	Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.	Day 1 to 6 weeks
Primary	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.	Day 1 to Day 43
Primary	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.	Day 1 to 6 weeks
Secondary	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;	Day 1 to 6 weeks
Secondary	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).	Day 1 to 6 weeks