Niclosamide for Mild to Moderate COVID-19

Tufts University

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Other: Telehealth monitoring; Drug: Niclosamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04399356

STUDY00000605

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 2 patient groups, including a placebo group

Niclosamide

Active Comparator group

Description:

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)

Treatment:

Drug: Niclosamide

Other: Telehealth monitoring

Control

Placebo Comparator group

Description:

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)

Treatment:

Other: Telehealth monitoring

Drug: Placebo