#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19 (#StayHome)
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|ClinicalTrials.gov Identifier: NCT04385264|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Drug: Mannitol||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||#StayHome: Efficacy of Early Hydroxychloroquine in Outpatients to Reduce Secondary Hospitalisation and Household Transmission of COVID-19 in Switzerland: A Double-blind, Randomised, Placebo-controlled Trial|
|Estimated Study Start Date :||May 12, 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Placebo Comparator: Placebo
Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD
Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD
Other Name: Placebo
Hydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
- Proportion of poor outcomes (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]Proportion of secondary hospitalisations (and their length), ICU admissions (and their length) and deaths.
- Secondary household attack rate (in household contacts) [ Time Frame: From day 0 (diagnosis and enrolment of index case) to 14 days after the outcome of the index case is recorded (recovery, hospitalisation or death): Average of 25 days ]Proportion of a household with new seropositivity for SARS-CoV-2
- Subjective disease severity (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]An ordinal scale of disease severity using a visual analogue scale (0-10 where 0 is asymptomatic)
- Rate of acute respiratory distress syndrome (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]As recorded during hospitalisation
- Severity of radiological lung pathology (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]Measured with lung ultrasound, CT or x-ray
- Objective disease severity (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]An ordinal scale of disease severity using the evolution of clinical biomarkers such as oxygen saturation, respiration rate etc.
- Safety: Unintended toxic HCQ accumulation (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive : Average of 11 days ]Plasma concentrations of HCQ measured by liquid chromatography-tandem mass spectrometry
- Safety: Adverse events (in index cases) [ Time Frame: During the period that the subject is considered as COVID-19-positive : Average of 11 days ]Ambulatory ECG and intensive monitoring for adverse events
- Social distancing knowledge, attitudes and practices amongst index cases and household contacts [ Time Frame: During the period that the subject is considered as COVID-19-positive: Average of 11 days ]Visual analogue scores for social distancing practices (0-5, where 0 is no social distancing at all)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385264
|Contact: Blaise Genton, MD-PhD||+41 21 314 49 firstname.lastname@example.org|
|Contact: Jacques Cornuz, MD-PhD||+41 21 314 60 email@example.com|
|Lausanne, Vaud, Switzerland, 1015|
|Contact: Blaise Genton, MD-PhD +41 21 314 49 32 firstname.lastname@example.org|
|Contact: Jacques Cornuz, MD-PhD +41 21 314 60 60 email@example.com|
|Principal Investigator: Blaise Genton, MD-PhD|
|Principal Investigator: Mary-Anne Hartley, MD, PhD, MPH|
|Sub-Investigator: Alix Miauton, MD|
|Sub-Investigator: Valérie D'Acremont, MD-PhD|
|Principal Investigator:||Blaise Genton, MD-PhD||Unisanté|
|Principal Investigator:||Mary-Anne Hartley, MD, PhD MPH||Unisanté|