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Niclosamide In Moderate COVID-19

Sponsor
First Wave Bio, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04436458
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

Study Description

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
  • Drug: Niclosamide Oral Tablet
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Actual Study Start Date :
Jan 20, 2022
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jan 20, 2022

Arms and Interventions

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

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 [From Day 1 to 42]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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:
NCT04436458
Other Study ID Numbers:
  • FW-COV-002
First Posted:
Jun 18, 2020
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2021
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:
Niclosamide

Study Results

No Results Posted as of Feb 21, 2022