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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399356
Recruitment Status : Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
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 (SARS-CoV-2) 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 SARS outbreak in 2002 and has activity including 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). We hypothesize that the antiviral activity of Niclosamide may be extended to COVID-19.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 30, 2020

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. Fecal samples and oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. 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. Change in respiratory viral clearance (by PCR) [ Time Frame: Day 3 and 10 ]
    Oropharangeal swab


Secondary Outcome Measures :
  1. Fecal viral clearance (by PCR) [ Time Frame: Day 14 ]
    Fecal swab

  2. Reduction (change) in viral shedding (by PCR) [ Time Frame: Days 1,3,7,10,14 ]
    Oropharngeal swab



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 (PCR) test
  • No requirement for hospitalization at the time of enrollment

Exclusion Criteria:

  • Evidence of respiratory failure, sepsis, organ dysfunction/ failure
  • Participation in another trial or use of any experimental treatment for COVID-19, including chloroquine, hydroxychloroquine, remdesivir, and lopinapir/ritonavir

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


Contacts
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Contact: Dorothy Dulko, PhD 617.636.7695 ddulko@tuftsmedicalcenter.org

Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Harry P Selker, MD Tufts Medical Center
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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
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents