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Niclosamide In Moderate COVID-19

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ClinicalTrials.gov Identifier: NCT04436458
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
First Wave Bio, Inc.

Study Description
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Brief Summary:
This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.

Condition or disease Intervention/treatment Phase
COVID Drug: Niclosamide Oral Tablet Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Niclosamide
Continued SOC therapy together with Niclosamide tablets for 14 days
 Drug: Niclosamide Oral Tablet
Continued SOC therapy together with niclosamide TID for 14 days
Placebo Comparator: Placebo
Continued SOC therapy together with placebo tablets matching niclosamide
 Drug: Placebo
Continued SOC therapy together with placebo tablets matching niclosamide for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group [ Time Frame: From Day 1 to 42 ]

Eligibility Criteria
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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:

  • Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.
  • Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day.
  • SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
  • Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

  • At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring 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 which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
Contacts and Locations
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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): NCT04436458


Contacts
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Contact: Tony Opipari, M.D. 734-546-0228 tony@firstwavebio.com

Sponsors and Collaborators
First Wave Bio, Inc.
More Information
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Responsible Party: First Wave Bio, Inc.
ClinicalTrials.gov Identifier: NCT04436458    
Other Study ID Numbers: FW-COV-002
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
 Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents