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

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ClinicalTrials.gov Identifier: NCT04858425
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
AzurRx BioPharma, Inc.

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
Covid19 Drug: Niclosamide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 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 : April 30, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

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




Primary Outcome Measures :
  1. SAEs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858425


Contacts
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Contact: Ansy Mathews 430-268-4344 amathews@firstwavebio.com

Locations
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Sponsors and Collaborators
AzurRx BioPharma, Inc.
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Responsible Party: AzurRx BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT04858425    
Other Study ID Numbers: AZ-NICL-COV-1
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AzurRx BioPharma, Inc.:
SARS-CoV-2
Covid
Covid19 Diarrhea
Covid19 GI Infection
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents