Control of COVID-19 Outbreaks in Long Term Care

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Appili Therapeutics Inc.
• Collaborators: Applied Health Research Centre; MOUNT SINAI HOSPITAL; Sunnybrook Health Sciences Centre; University Health Network, Toronto; University of Toronto
• Treatments: Favipiravir

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