This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).
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.
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.
Drug: 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.
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
Tufts Medical Center
Boston, Massachusetts, United States
Harry P Selker, MD, Principal Investigator
Tufts Medical Center