Niclosamide for Mild to Moderate COVID-19

Phase 2

Completed

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

Detailed 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 & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Niclosamide	Telehealth monitoring	Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)
Control	Telehealth monitoring	Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)
Control	Placebo	Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)
Niclosamide	Niclosamide	Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)

Primary Outcome Measures

Name	Time	Method
Time to Respiratory Viral Clearance	Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.	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.

Secondary Outcome Measures

Name	Time	Method
Time to Fecal Viral Clearance	Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.	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.
Number of Participants With Progression to Severe COVID-19 Disease	Day 1- 30	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.
Number of Days to Resolution of a Fever	Day 1-30	Mean time to fever resolution (symptom no longer reported).