Niclosamide In Moderate COVID-19
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04436458 |
Recruitment Status :
Withdrawn
(Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.)
First Posted : June 18, 2020
Last Update Posted : February 21, 2022
|
Sponsor:
First Wave Bio, Inc.
Information provided by (Responsible Party):
First Wave Bio, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Type : | Interventional (Clinical Trial) |
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 : | January 20, 2022 |
Actual Primary Completion Date : | January 20, 2022 |
Actual Study Completion Date : | January 20, 2022 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
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 |
Primary Outcome Measures :
- 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 ]
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.
No Contacts or Locations Provided
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 21, 2022 |
Last Verified: | February 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 Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics |
Antiparasitic Agents Anti-Infective Agents Antinematodal Agents |