#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
Status:
Suspended
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
BACKGROUND Despite drastic quarantine measures, COVID-19 continues to propagate and threatens
global healthcare systems by saturating their capacity with high transmissibility and the
particularly protracted length of stay needed by those requiring intensive care. Indeed, once
patients advance to the ICU, prognosis is poor and it is thus critical to test medications
that may prevent complications and reduce viral shedding. i.e. to protect ambulatory patients
and their families from complications and transmission and allow them to #StayHome.
To date, no treatment has been reliably demonstrated as effective in COVID-19 patients.
Hydroxychloroquine (HCQ), a common and well tolerated medication, has shown promise in vitro
for reducing viral replication (for SARS-CoV-2 as well as other coronaviruses with pandemic
potential such as SARS-CoV-1 and MERS). Since then, several small-scale hospital-based
clinical studies have indicated the potential for reduced viral shedding and hospitalisation
as well as favourable evolution of lung pathology. If started earlier, this treatment could
prevent complications requiring hospitalisation and intensive care, which may not be
available in low-income countries.
Robust clinical trials are required to assess the potential of HCQ in COVID-19.
OBJECTIVES This trial assesses the efficacy of early treatment with HCQ in COVID-19
outpatients to reduce the incidence and severity of complications including secondary
hospitalisation, ICU admissions, lung pathology and death. Secondarily, this trial will also
assess its efficacy to reduce viral transmission among household contacts during
self-quarantine. The clinical data collected in this trial will also be critical in creating
early prognostication models to better predict healthcare needs and have evidence-based
prioritization of resource allocation, which is especially critical in low-resource settings.
METHODS The trial will recruit 800 SARS-CoV-2+ patients and their household contacts at
triage sites across Switzerland. Patients included are 1) at risk of poor outcome
(comorbidities or >65y) and 2) well enough to self-isolate at home. These patients will be
randomised 1:1 in HCQ:Placebo and given 6 days of early treatment (within 24 hours of the
SARS-CoV-2 test). Intensive pragmatic multiparameter at-home follow-up (including
point-of-care lung ultrasound in some sites) will continue until their outcome (resolution,
or complications, such as hospitalisation, ICU admission, death). Household contacts will
have before and after serological testing and social distancing knowledge and practices
questionnaires to assess risk factors for infections. The household attack rate of new-onset
infections can then assess the efficacy of HCQ to prevent transmission.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland