Niclosamide In Moderate COVID-19

COVID Clinical Trial

Official title:

Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04436458
• Other study ID #: FW-COV-002
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 20, 2022
• Est. completion date: January 20, 2022

Study information

• Verified date: February 2021
• Source: First Wave Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• Niclosamide Oral Tablet
Continued SOC therapy together with niclosamide TID for 14 days
• Placebo
Continued SOC therapy together with placebo tablets matching niclosamide for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Wave Bio, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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