Control of COVID-19 Outbreaks in Long Term Care

NCT04448119 | Terminated Phase 2

• 1 other identifier: CONTROL-COVID-Favipiravir-1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; Long-Term Care Home; Favipiravir; Chemoprophylaxis; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Control of Outbreak

  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

  Day 40

Secondary Outcomes (9)

• Mortality (Residents)

  Day 40, Day 60

• COVID-19 Infection (Residents)

  Day 40

• COVID-19 Infection (Staff)

  Day 14, Day 40

• Hospitalization (Residents)

  Day 40

• Medication Discontinuation (Residents)

  Day 40

Study Arms (2)

Chemoprophylaxis

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Favipiravir DRUG

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.

Also known as: Avigan

Chemoprophylaxis

Favipiravir Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• \. Informed consent from resident or substitute decision maker (SDM)
• Expected to work at least two 8-hour shifts, or the equivalent time (16 hours on the unit) during the outbreak period.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Appili Therapeutics Inc.: lead
• MOUNT SINAI HOSPITAL: collaborator
• Applied Health Research Centre: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• University Health Network, Toronto: collaborator
• University of Toronto: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Allison J McGeer, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: October 16, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)