Control of COVID-19 Outbreaks in Long Term Care
|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: NCT04448119|
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : October 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV-2||Drug: Favipiravir Drug: Favipiravir Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||760 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID)|
|Actual Study Start Date :||October 16, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
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.
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.
Other Name: Avigan
Placebo Comparator: Placebo
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.
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.
- Control of Outbreak [ Time Frame: Day 40 ]Control of outbreak, defined as no new cases of COVID-19 in residents for 24 consecutive days up to day 40 after the start of prophylaxis
- Mortality (Residents) [ Time Frame: Day 40, Day 60 ]The proportion of residents of included LTCH units who die up to day 40, and up to day 60
- COVID-19 Infection (Residents) [ Time Frame: Day 40 ]The proportion of residents of included LTCH units who were uninfected at baseline and develop new symptomatic microbiologically confirmed COVID-19 up to day 40
- COVID-19 Infection (Staff) [ Time Frame: Day 14, Day 40 ]The proportion of exposed staff uninfected at baseline in whom SARS-CoV-2 infection is identified up to day 14 and up to day 40
- Hospitalization (Residents) [ Time Frame: Day 40 ]The proportion of residents of included LTCH units hospitalized up to day 40
- Medication Discontinuation (Residents) [ Time Frame: Day 40 ]The proportion of residents of included LTCH units who discontinue study medication due to adverse events
- Medication Discontinuation (Staff) [ Time Frame: Day 40 ]The proportion of LTCH staff of included LTCH units who discontinue study medication due to adverse events
- COVID-19 in new LTCH Units (a) [ Time Frame: Day 40 ]The occurrence of new microbiologically confirmed COVID-19 infections in residents in other units of the LTCH up to day 40 (dichotomous, at LTCH level)
- COVID-19 in new LTCH Units (b) [ Time Frame: Day 40 ]The proportion of previously unaffected LTCH units of the remainder of the LTCH in which a case of COVID-19 is identified
- COVID-19 in new LTCH Units (c) [ Time Frame: Day 40 ]The proportion of residents in the remainder of the LTCH who develop COVID-19 infections up to day 40
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): NCT04448119
|Contact: Yoav Golan, MD||+1 617 firstname.lastname@example.org|
|Contact: Allison J McGeer, MD||+1 416-586-3123||Allison.McGeer@sinaihealth.ca|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Allison J McGeer, MD +1 416-586-3123 Allison.McGeer@sinaihealth.ca|
|Principal Investigator:||Allison J McGeer, MD||MOUNT SINAI HOSPITAL|