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#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19 (#StayHome)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385264
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Mannitol Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD
Drug: Mannitol
Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD
Other Name: Placebo

Experimental: Hydroxychloroquine
Hydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Drug: Hydroxychloroquine
Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Other Names:
  • Plaquenil
  • HCQ




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  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)

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Blaise Genton, MD-PhD +41 21 314 49 32 blaise.genton@unisante.ch
Contact: Jacques Cornuz, MD-PhD +41 21 314 60 60 jacques.cornuz@unisante.ch

Locations
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Switzerland
Unisanté
Lausanne, Vaud, Switzerland, 1015
Contact: Blaise Genton, MD-PhD    +41 21 314 49 32    blaise.genton@unisante.ch   
Contact: Jacques Cornuz, MD-PhD    +41 21 314 60 60    jacques.cornuz@unisante.ch   
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         
Sponsors and Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Investigators
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Principal Investigator: Blaise Genton, MD-PhD Unisanté
Principal Investigator: Mary-Anne Hartley, MD, PhD MPH Unisanté
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Responsible Party: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT04385264    
Other Study ID Numbers: Unisante
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The aim is to share data, protocols, information sheets, CRFs and analytical code as soon as possible. Data will first be cleaned and anonymised and then subjected to rigorous assessments to secure patient privacy and analytical robustness according to the FAIR principles.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Unknown (determined by the evolution of the epidemic)
Access Criteria: On request by researchers agreeing to use the data for it intended purpose: i.e. to further knowledge of the efficacy and safety of HCQ in COVID-19 and to better understand the disease.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland:
Hydroxychloroquine
Additional relevant MeSH terms:
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Hydroxychloroquine
Mannitol
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs