#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19 (#StayHome)
Primary Purpose
COVID-19
Status
Suspended
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Hydroxychloroquine
Mannitol
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Hydroxychloroquine
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
Sites / Locations
- Unisanté
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Hydroxychloroquine
Arm Description
Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD
Hydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Outcomes
Primary Outcome Measures
Proportion of poor outcomes (in index cases)
Proportion of secondary hospitalisations (and their length), ICU admissions (and their length) and deaths.
Secondary Outcome Measures
Secondary household attack rate (in household contacts)
Proportion of a household with new seropositivity for SARS-CoV-2
Subjective disease severity (in index cases)
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)
As recorded during hospitalisation
Severity of radiological lung pathology (in index cases)
Measured with lung ultrasound, CT or x-ray
Objective disease severity (in index cases)
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)
Plasma concentrations of HCQ measured by liquid chromatography-tandem mass spectrometry
Safety: Adverse events (in index cases)
Ambulatory ECG and intensive monitoring for adverse events
Social distancing knowledge, attitudes and practices amongst index cases and household contacts
Visual analogue scores for social distancing practices (0-5, where 0 is no social distancing at all)
Full Information
NCT ID
NCT04385264
First Posted
April 21, 2020
Last Updated
May 6, 2021
Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04385264
Brief Title
#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
Acronym
#StayHome
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Suspended
Why Stopped
Sufficient number of subjects would probably not reach
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Hydroxychloroquine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
Hydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil, HCQ
Intervention Description
Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
Intervention Type
Drug
Intervention Name(s)
Mannitol
Other Intervention Name(s)
Placebo
Intervention Description
Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD
Primary Outcome Measure Information:
Title
Proportion of poor outcomes (in index cases)
Description
Proportion of secondary hospitalisations (and their length), ICU admissions (and their length) and deaths.
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary Outcome Measure Information:
Title
Secondary household attack rate (in household contacts)
Description
Proportion of a household with new seropositivity for SARS-CoV-2
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
Title
Subjective disease severity (in index cases)
Description
An ordinal scale of disease severity using a visual analogue scale (0-10 where 0 is asymptomatic)
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
Title
Rate of acute respiratory distress syndrome (in index cases)
Description
As recorded during hospitalisation
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
Title
Severity of radiological lung pathology (in index cases)
Description
Measured with lung ultrasound, CT or x-ray
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
Title
Objective disease severity (in index cases)
Description
An ordinal scale of disease severity using the evolution of clinical biomarkers such as oxygen saturation, respiration rate etc.
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
Title
Safety: Unintended toxic HCQ accumulation (in index cases)
Description
Plasma concentrations of HCQ measured by liquid chromatography-tandem mass spectrometry
Time Frame
During the period that the subject is considered as COVID-19-positive : Average of 11 days
Title
Safety: Adverse events (in index cases)
Description
Ambulatory ECG and intensive monitoring for adverse events
Time Frame
During the period that the subject is considered as COVID-19-positive : Average of 11 days
Title
Social distancing knowledge, attitudes and practices amongst index cases and household contacts
Description
Visual analogue scores for social distancing practices (0-5, where 0 is no social distancing at all)
Time Frame
During the period that the subject is considered as COVID-19-positive: Average of 11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaise Genton, MD-PhD
Organizational Affiliation
Unisanté
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary-Anne Hartley, MD, PhD MPH
Organizational Affiliation
Unisanté
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unisanté
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1015
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Unknown (determined by the evolution of the epidemic)
IPD Sharing 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.
Learn more about this trial
#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
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