Niclosamide for Mild to Moderate COVID-19

COVID-19 Clinical Trial

Official title:

Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399356
• Other study ID #: STUDY00000605
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: August 19, 2021

Study information

• Verified date: April 2022
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).

Description:

Niclosamide, which has potent antiviral activity against single-stranded RNA viruses including coronaviruses, was proposed as an antiviral during the Severe Acute Respiratory Syndrome (SARS) outbreak in 2002 and has activity including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) where it was found to inhibit SARS coronavirus, SARS-CoV, in in vitro studies and similarly structured RNA viruses (both in vitro and in vivo). The investigators hypothesize that the antiviral activity of Niclosamide may be extended to COVID-19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 19, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive SARS-CoV-2 test by PCR

• No requirement of oxygen supplementation

• Ability to take oral medication

Exclusion Criteria:

• Known allergic reactions to any components of Niclosamide medication

• Participation in another trial or use of any experimental treatment for COVID-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir

• Hospitalization or requirement of hospitalization at the time of enrollment

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Niclosamide
Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.
• Placebo
The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.

Other:
• Telehealth monitoring
In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cairns DM, Dulko D, Griffiths JK, Golan Y, Cohen T, Trinquart L, Price LL, Beaulac KR, Selker HP. Efficacy of Niclosamide vs Placebo in SARS-CoV-2 Respiratory Viral Clearance, Viral Shedding, and Duration of Symptoms Among Patients With Mild to Moderate C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Respiratory Viral Clearance	Respiratory viral clearance is defined as the first day a participant's oropharyngeal (oral) sample result is negative, provided that none of the subsequent oral sample results are positive. We will calculate the time to clearance since Day 1.	Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
Secondary	Time to Fecal Viral Clearance	Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21. Fecal viral clearance is defined as the first day a participant's fecal sample result is negative, provided that none of the subsequent fecal sample results are positive; calculated as the time to clearance since Day 1.	Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
Secondary	Number of Participants With Progression to Severe COVID-19 Disease	Defined as 1) O2 saturation <92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death. 1) We will compare the proportion of participants who progressed to severe COVID disease between groups.	Day 1- 30
Secondary	Number of Days to Resolution of a Fever	Mean time to fever resolution (symptom no longer reported).	Day 1-30

External Links

•   JAMA open network PMID: 35138402