Clinical trial NCT04385264: #StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: Hydroxychloroquine
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: INCLUSION CRITERIA (index cases):

* Age \>=18 years old AND
* SARS-CoV-2 positive AND
* Well enough to self-isolate at home (at an address in Switzerland) AND
* At risk of complications from COVID-19 i.e. one or more of the following

  * Age \>=65 years
  * Hypertension
  * Diabetes
  * Cardiovascular disease (History of infarction OR peripheral arteriopathy OR cerebrovascular accident OR cardiac insufficiency)
  * Chronic respiratory disease
  * Immunosuppression
  * Cancer
  * Obesity (BMI\>40)

EXCLUSION CRITERIA (index cases):

* Allergy to hydroxychloroquine/4-aminoquinilones
* Retinal eye disease
* Known chronic kidney disease, stage 4 or 5 or receiving dialysis
* Weight \< 40 kg
* Known porphyria
* Known psoriasis
* Known myasthenia gravis
* Taking drugs with moderate-severe interactions with HCQ
* Taking ≥ 2 QT prolonging drugs
* Taking 1 QT prolonging drug AND a loop diuretic
* Moderate or severe heart failure
* Severe or uncontrolled arrhythmia
* Recent myocardial infarction or stroke (past 6 months)
* Current pregnancy
* Current hospitalisation
* Known hemolytic anaemia

INCLUSION CRITERIA (household contacts):

* Age \>1 year old AND
* Living in same household as index case during self-isolation

EXCLUSION CRITERIA (household contacts):

* History of laboratory-confirmed SARS-CoV-2 infection

Primary outcomes:
measure: Proportion of poor outcomes (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary outcomes:
measure: Secondary household attack rate (in household contacts)
timeFrame: 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
measure: Subjective disease severity (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
measure: Rate of acute respiratory distress syndrome (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
measure: Severity of radiological lung pathology (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
measure: Objective disease severity (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
measure: Safety: Unintended toxic HCQ accumulation (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive : Average of 11 days
measure: Safety: Adverse events (in index cases)
timeFrame: During the period that the subject is considered as COVID-19-positive : Average of 11 days
measure: Social distancing knowledge, attitudes and practices amongst index cases and household contacts
timeFrame: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Unisanté
state: Vaud
Study officials:
affiliation: Unisanté
name: Blaise Genton, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unisanté
name: Mary-Anne Hartley, MD, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: