Back to resultsNiclosamide for Mild to Moderate COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Niclosamide
Placebo
Telehealth monitoring
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Coronavirus, Treatment, Pill, Telehealth, Viral shedding
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
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Niclosamide
Control
Arm 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)
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)
Outcomes
Primary Outcome Measures
Time to Respiratory Viral Clearance
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.
Secondary Outcome Measures
Time to Fecal Viral Clearance
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.
Number of Participants With Progression to Severe COVID-19 Disease
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.
Number of Days to Resolution of a Fever
Mean time to fever resolution (symptom no longer reported).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04399356
Brief Title
Niclosamide for Mild to Moderate COVID-19
Official Title
Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the antihelmintic drug, Niclosamide, as a potential treatment for mild to moderate coronavirus disease 2019 (COVID-19).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Coronavirus, Treatment, Pill, Telehealth, Viral shedding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded randomized controlled trial.
Masking
ParticipantCare ProviderInvestigator
Masking Description
As all members of the Study Team will be blinded, Tufts Investigational Drug Services (IDS) will be unblinded and will dispense both the Niclosamide and placebo. The study intervention (Niclosamide) and placebo will be packaged and as indistinguishable as possible.
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niclosamide
Arm Type
Active Comparator
Arm 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)
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.
Intervention Type
Other
Intervention Name(s)
Telehealth monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Respiratory Viral Clearance
Description
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.
Time Frame
Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
Secondary Outcome Measure Information:
Title
Time to Fecal Viral Clearance
Description
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.
Time Frame
Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
Title
Number of Participants With Progression to Severe COVID-19 Disease
Description
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.
Time Frame
Day 1- 30
Title
Number of Days to Resolution of a Fever
Description
Mean time to fever resolution (symptom no longer reported).
Time Frame
Day 1-30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry P Selker, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35138402
Citation
Cairns DM, Dulko D, Griffiths JK, Golan Y, Cohen T, Trinquart L, Price LL, Beaulac KR, Selker HP. Efficacy of Niclosamide vs Placebo in SARS-CoV-2 Respiratory Viral Clearance, Viral Shedding, and Duration of Symptoms Among Patients With Mild to Moderate COVID-19: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2144942. doi: 10.1001/jamanetworkopen.2021.44942.
Results Reference
result
Links:
URL
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788857
Description
JAMA open network PMID: 35138402
Learn more about this trial
Niclosamide for Mild to Moderate COVID-19
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