Niclosamide in COVID-19

Covid19 Clinical Trial

Official title:

A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04542434
• Other study ID #: FW-COV-003
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 20, 2022
• Est. completion date: January 20, 2022

Study information

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

Clinical Trial Summary

This is a two-part, 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• Status: Withdrawn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:

• Part 1 only: Patients hospitalized with a primary diagnosis 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. Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.
• Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
• SARS-CoV-2 RNA presence 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-19
• Covid19

Intervention

Drug:
• Niclosamide Oral Tablet
Niclosamide tablets 400 mg 3 times daily for 14 days
• Placebo
Matching placebo tablets 3 times daily 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	Mortality	All-cause mortality	From Day 1 to 6 weeks
Primary	TEAE	Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation	From Day 1 to 6 weeks
Primary	SAEs	Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)	From Day 1 to end of study
Primary	Safety laboratory	Change in safety laboratory tests 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	From Day 1 to 6 weeks
Primary	Blood pressure	Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
Primary	fecal RNA virus clearance	time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)	From Day 1 to 6 weeks
Primary	Body temperature	Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
Primary	Heart rate	Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
Primary	SaO2	Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables	From Day 1 to 6 weeks
Primary	ECG	Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks	From Day 1 to 6 weeks