Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Overview
- Phase
- Phase 2
- Intervention
- Niclosamide
- Conditions
- COVID-19
- Sponsor
- Tufts Medical Center
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Time to Respiratory Viral Clearance
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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)
Intervention: 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)
Intervention: Telehealth monitoring
Control
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)
Intervention: Placebo
Control
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)
Intervention: Telehealth monitoring
Outcomes
Primary Outcomes
Time to Respiratory Viral Clearance
Time Frame: 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 Outcomes
- Time to Fecal Viral Clearance(Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.)
- Number of Participants With Progression to Severe COVID-19 Disease(Day 1- 30)
- Number of Days to Resolution of a Fever(Day 1-30)