Phase 2 N=73 Randomized Triple-blind Treatment

Niclosamide for Mild to Moderate COVID-19

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04399356 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcome: Primary: Time to Respiratory Viral Clearance — 3.39; 3.44 Days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Niclosamide (Drug); Placebo (Drug); Telehealth monitoring (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tufts Medical Center
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Respiratory Viral Clearance	3.39; 3.44	—
SECONDARY Time to Fecal Viral Clearance	6.12; 5.77	—
SECONDARY Number of Participants With Progression to Severe COVID-19 Disease	0; 1	—
SECONDARY Number of Days to Resolution of a Fever	10.2; 3.6	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04399356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.