CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Niclosamide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04399356
NCT04399356Phase 2Completed

Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)

Tufts Medical Center·interventional·Posted May 22, 2020·Updated Apr 12, 2022

In Brief

A Phase 2 clinical trial evaluating Niclosamide, Placebo, and 1 other intervention for COVID-19. Completed, enrolled 73 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 22, 2020
Enrollment StartOct 1, 2020
Primary CompletionApr 20, 2021
Study CompletionAug 19, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.1 years ago

Interventions

Niclosamidedrug

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.

Placebodrug

The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.

Telehealth monitoringother

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.