- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399356
Niclosamide for Mild to Moderate COVID-19
April 8, 2022 updated by: Tufts Medical Center
Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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)
|
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.
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.
|
Placebo Comparator: 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)
|
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.
The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Fecal Viral Clearance
Time Frame: Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
|
Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
Fecal viral clearance is defined as the first day a participant's fecal sample result is negative, provided that none of the subsequent fecal sample results are positive; calculated as the time to clearance since Day 1.
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Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
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Number of Participants With Progression to Severe COVID-19 Disease
Time Frame: Day 1- 30
|
Defined as 1) O2 saturation <92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death.
1) We will compare the proportion of participants who progressed to severe COVID disease between groups.
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Day 1- 30
|
Number of Days to Resolution of a Fever
Time Frame: Day 1-30
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Mean time to fever resolution (symptom no longer reported).
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Day 1-30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harry P Selker, MD, Tufts Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
April 20, 2021
Study Completion (Actual)
August 19, 2021
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Anti-Infective Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Niclosamide
Other Study ID Numbers
- STUDY00000605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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