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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 : Not yet recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborators:
MOUNT SINAI HOSPITAL
Applied Health Research Centre
Sunnybrook Health Sciences Centre
University Health Network, Toronto
University of Toronto
Information provided by (Responsible Party):
Appili Therapeutics Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: Favipiravir Drug: Favipiravir Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID)
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Chemoprophylaxis
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.
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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Hospitalization (Residents) [ Time Frame: Day 40 ]
    The proportion of residents of included LTCH units hospitalized up to day 40

  5. Medication Discontinuation (Residents) [ Time Frame: Day 40 ]
    The proportion of residents of included LTCH units who discontinue study medication due to adverse events

  6. Medication Discontinuation (Staff) [ Time Frame: Day 40 ]
    The proportion of LTCH staff of included LTCH units who discontinue study medication due to adverse events

  7. 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)

  8. 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

  9. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for LTCHs:

    1. LTCH in Ontario with >80% of residents being adults ≥65 years of age.
    2. Residents are or can be routinely assessed at least daily by staff.
    3. LTCH has not previously had a unit enrolled in this study.
    4. Outbreak of COVID-19 declared on at least one nursing unit, requiring all of the following:

      1. ≥2 to ≤4 residents who develop PCR-confirmed symptomatic COVID-19 infection on the same unit within ≤ 7 days at the time when the outbreak is identified as eligible.
      2. ≤21 days from symptom onset in the index case at the time when the outbreak is identified as eligible.
      3. Cumulative attack rate in residents on the affected unit since the beginning of the pandemic ≤25% at the time when the outbreak is identified as eligible.
      4. ≤20% of residents with microbiologically confirmed COVID-19 or line-listed as a presumptive case in a COVID-19 outbreak and not tested for COVID-19 in prior outbreaks within the last six months.
      5. Nursing unit with ≥16 and ≤32 residents.
      6. Nursing home agrees to work with study coordination to minimize the number of persons who provide care on the unit.
    5. Mechanism exists for delivery of medication and recording of administered medication for all residents.
    6. ≥80% of residents on outbreak unit are eligible and they or their substitute decision makers consent to participate in the study.
    7. Written informed consent of Medical Director, Administrator and a delegate of the Residents' Council of the LTCH for LTCH to be included in the cluster trial.
  • Inclusion criteria for LTCH residents:

    1. Informed consent from resident or substitute decision maker (SDM)

  • Inclusion criteria for LTCH staff:

    1. Expected to work at least two 8-hour shifts, or the equivalent time (16 hours on the unit) during the outbreak period.
    2. Informed consent.

Exclusion Criteria:

  • Exclusion criteria for LTCHs:

    1. Inability to deliver medication to consenting residents within 96 hours of identification of the outbreak.
    2. Inability to define a physically separate unit with ≤32 residents.
    3. Any of facility management, medical advisory committee or resident council do not approve participation.
  • Exclusion criteria for LTCH Residents and Staff:

    1. Pregnancy (females < 55 years of age require a negative urine pregnancy test at enrollment, and either menopause or two concurrent reliable methods of contraception need to be confirmed)
    2. History of abnormalities of uric acid metabolism, other than gout.
    3. History of hypersensitivity to remdesivir or favipiravir
    4. Previous diagnosis of hepatic cirrhosis
    5. Current use of the following medications, which cannot be discontinued for the duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen per day

Information from the National Library of Medicine

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


Contacts
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Contact: Yoav Golan, MD +1 617 240-6666 ygolan@appilitherapeutics.com
Contact: Allison J McGeer, MD +1 416-586-3123 Allison.McGeer@sinaihealth.ca

Sponsors and Collaborators
Appili Therapeutics Inc.
MOUNT SINAI HOSPITAL
Applied Health Research Centre
Sunnybrook Health Sciences Centre
University Health Network, Toronto
University of Toronto
Investigators
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Principal Investigator: Allison J McGeer, MD MOUNT SINAI HOSPITAL
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Responsible Party: Appili Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04448119    
Other Study ID Numbers: CONTROL-COVID-Favipiravir-1
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Appili Therapeutics Inc.:
COVID-19
Long-Term Care Home
Favipiravir
Chemoprophylaxis
SARS-CoV-2