Status:
TERMINATED
Control of COVID-19 Outbreaks in Long Term Care
Lead Sponsor:
Appili Therapeutics Inc.
Collaborating Sponsors:
MOUNT SINAI HOSPITAL
Applied Health Research Centre
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 out...
Detailed Description
Early in the COVID-19 pandemic, it became apparent that the elderly are disproportionately bearing the burden of disease and mortality. Many outbreaks are occurring in long-term care homes (LTCHs), wi...
Eligibility Criteria
Inclusion
- Inclusion criteria for LTCHs:
- LTCH in Ontario with \>80% of residents being adults ≥65 years of age.
- Residents are or can be routinely assessed at least daily by staff.
- LTCH has not previously had a unit enrolled in this study.
- Outbreak of COVID-19 declared on at least one nursing unit, requiring all of the following:
- ≥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.
- ≤21 days from symptom onset in the index case at the time when the outbreak is identified as eligible.
- 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.
- ≤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.
- Nursing unit with ≥16 and ≤32 residents.
- Nursing home agrees to work with study coordination to minimize the number of persons who provide care on the unit.
- Mechanism exists for delivery of medication and recording of administered medication for all residents.
- ≥80% of residents on outbreak unit are eligible and they or their substitute decision makers consent to participate in the study.
- 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:
- Expected to work at least two 8-hour shifts, or the equivalent time (16 hours on the unit) during the outbreak period.
- Informed consent.
Exclusion
- Exclusion criteria for LTCHs:
- Inability to deliver medication to consenting residents within 96 hours of identification of the outbreak.
- Inability to define a physically separate unit with ≤32 residents.
- Any of facility management, medical advisory committee or resident council do not approve participation.
- Exclusion criteria for LTCH Residents and Staff:
- 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)
- History of abnormalities of uric acid metabolism, other than gout.
- History of hypersensitivity to remdesivir or favipiravir
- Previous diagnosis of hepatic cirrhosis
- 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
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04448119
Start Date
October 16 2020
End Date
October 30 2021
Last Update
February 21 2023
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada