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Chemoprophylaxis for COVID-19

Phase 2
Waitlist Available
Led By Allison J McGeer, MD
Research Sponsored by Appili Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 40, day 60
Awards & highlights

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.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 40, day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 40, day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Control of Outbreak
Secondary outcome measures
COVID-19 Infection (Residents)
COVID-19 Infection (Staff)
COVID-19 in new LTCH Units (a)
+6 more

Side effects data

From 2020 Phase 3 trial • 200 Patients • NCT04542694
19%
Increased alanine aminotransferase activity
13%
Increased aspartate aminotransferase activity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Favipiravir (Areplivir)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ChemoprophylaxisExperimental Treatment1 Intervention
Participants of LTCH units allocated to the chemoprophylaxis arm receive favipiravir for 25 days. Residents in the LTCH unit diagnosed with COVID- 19 at enrollment will be offered treatment with favipiravir for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants of LTCH units allocated to the control arm receive placebo for 25 days. Residents in the LTCH unit diagnosed with COVID-19 at enrollment will be offered treatment with placebo for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Favipiravir
FDA approved

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
655 Previous Clinical Trials
1,550,179 Total Patients Enrolled
12 Trials studying COVID-19
10,012 Patients Enrolled for COVID-19
University Health Network, TorontoOTHER
1,466 Previous Clinical Trials
484,298 Total Patients Enrolled
27 Trials studying COVID-19
113,327 Patients Enrolled for COVID-19
University of TorontoOTHER
689 Previous Clinical Trials
1,018,576 Total Patients Enrolled
16 Trials studying COVID-19
14,274 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Control of COVID-19 Outbreaks in Long Term Care
2020. "Control of COVID-19 Outbreaks in Long Term Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04448119.
~15 spots leftby Apr 2025
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