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Niclosamide for Mild to Moderate COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399356
Recruitment Status : Completed
First Posted : May 22, 2020
Results First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Niclosamide Drug: Placebo Other: Telehealth monitoring Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Official Title: Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : April 20, 2021
Actual Study Completion Date : August 19, 2021

Resource links provided by the National Library of Medicine


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)
Drug: Niclosamide
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.

Other: Telehealth monitoring
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)
Drug: Placebo
The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.

Other: Telehealth monitoring
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of Days to Resolution of a Fever [ Time Frame: Day 1-30 ]
    Mean time to fever resolution (symptom no longer reported).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399356


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Harry P Selker, MD Tufts Medical Center
  Study Documents (Full-Text)

Documents provided by Tufts Medical Center:
Study Protocol  [PDF] February 1, 2021
Statistical Analysis Plan  [PDF] August 10, 2021

Additional Information:
Publications of Results:
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04399356    
Other Study ID Numbers: STUDY00000605
First Posted: May 22, 2020    Key Record Dates
Results First Posted: April 12, 2022
Last Update Posted: April 12, 2022
Last Verified: April 2022

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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
Keywords provided by Tufts Medical Center:
SARS-CoV-2
Coronavirus
Treatment
Pill
Telehealth
Viral shedding
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents