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Control of COVID-19 Outbreaks in Long Term Care

NCT04448119 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-02-21

No results posted yet for this study

Summary

To address the need to intervene to prevent the spread of COVID-19 in long-term care homes, we propose a randomized clinical trial of chemoprophylaxis in long-term care homes experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio.

Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy for outbreak control. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.

Conditions

Interventions

DRUG

Favipiravir

Favipiravir is the experimental drug. The dosage for favipiravir to be used in this study for prophylaxis is 1600 mg (8 x 200 mg tablets) orally twice daily on day 1 followed by 800 mg (4 x 200 mg tablets) orally twice daily on days 2-25. The dose of favipiravir for treatment is 2000 mg orally twice daily on day 1, the 1000 mg orally twice daily for 13 additional days.

DRUG

Favipiravir Placebo

Favipiravir Placebo is the placebo drug. For chemoprophylaxis, the dosage of favipiravir placebo is 8 tablets orally twice daily on day 1, followed by 4 tablets twice daily from days 2-25. The dosage of favipiravir placebo for treatment is 10 tablets orally twice daily on day 1, followed by tablets twice daily from days 2-14.

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Applied Health Research Centre

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Appili Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Allison J McGeer, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2021-10-30
Completion
2021-10-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448119 on ClinicalTrials.gov