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Completed

NCT Number: NCT04399356

Niclosamide for Mild to Moderate COVID-19

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niclosamide

Drug

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.

Placebo

Drug

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

Telehealth monitoring

Other

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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