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Lessons from the PROTECT-CH COVID-19 platform trial in care homes.

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Summary

This study aimed to test antiviral drugs for COVID-19 in care homes but was stopped due to vaccination success. The role of postexposure prophylaxis in this setting remains unclear.

Keywords:
CARE HOMECICLESONIDECLUSTER TRIALCOVID-19NICLOSAMIDENURSING HOMEPREVENTIONPROPHYLAXISRANDOMISED CONTROLLED TRIALRESIDENTIAL HOME

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Area of Science:

  • Geriatric Medicine
  • Infectious Diseases
  • Clinical Trials

Background:

  • Coronavirus disease-2019 (COVID-19) caused significant mortality and morbidity in UK care homes in 2020-2021.
  • Repurposed antiviral drugs were considered for reducing COVID-19 transmission, infection, replication, and inflammation.

Purpose of the Study:

  • To compare the safety and efficacy of potential antiviral drugs (ciclesonide, niclosamide) for postexposure prophylaxis in care home residents.
  • To evaluate the impact of these antivirals on mortality, hospitalization, and infection rates.

Main Methods:

  • A cluster-randomised, open-label, blinded end-point platform trial was designed.
  • Eligible participants were aged 65+ in UK care homes, receiving either antiviral plus standard care or standard care alone.
  • The primary outcome was a composite of all-cause mortality, hospitalization, or SARS-CoV-2 infection at 60 days.

Main Results:

  • The trial was stopped in September 2021 due to high vaccination rates in care homes, which significantly reduced infections.
  • The infrastructure for a large-scale clinical trial in UK care homes was developed, but the feasibility of drug efficacy was not tested.
  • Numerous logistical delays, including contracting and regulatory hurdles, impacted the trial's initiation.

Conclusions:

  • The success of vaccination rendered the trial unable to assess the role of postexposure prophylaxis for COVID-19 in care home residents.
  • Significant progress was made in building research infrastructure and expertise for future trials in this setting.
  • Urgent removal of logistical barriers is needed for future care home research, potentially through a pandemic-ready platform trial.