Niclosamide for Mild to Moderate COVID-19

NCT04399356 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00000605
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

SARS-CoV-2; Coronavirus; Treatment; Pill; Telehealth; Viral shedding

Outcome Measures

Primary Outcomes (1)

• 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.

  Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.

Secondary Outcomes (3)

• Time to Fecal Viral Clearance

  Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.

• Number of Participants With Progression to Severe COVID-19 Disease

  Day 1- 30

• Number of Days to Resolution of a Fever

  Day 1-30

Study Arms (2)

Niclosamide

ACTIVE COMPARATOR

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; Other: Telehealth monitoring

Control

PLACEBO COMPARATOR

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; Other: Telehealth monitoring

Interventions

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.

Niclosamide

Placebo DRUG

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

Control

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.

Control; Niclosamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive SARS-CoV-2 test by PCR
• No requirement of oxygen supplementation
• Ability to take oral medication

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 35138402 RESULT

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines

Limitations and Caveats

There was a precipitous and persistent decrease in the rate of COVID-19 diagnoses in spring and summer 2021 that decreased our enrollment pool. Additionally, as vaccination rates rose, our predetermined exclusion criteria of individuals vaccinated against SARS-CoV-2 limited those available for enrollment.

Results Point of Contact

• Title: Dorothy Dulko, PhD - Research Project Director
• Organization: Tufts Medical Center

ddulko@Tuftsmedicalcenter.org

(617) 636-5009

Study Officials

• Harry P Selker, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled trial.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: October 1, 2020
• Primary Completion: April 20, 2021
• Study Completion: August 19, 2021
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-04

Locations

US (1)