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

January 3, 2025 updated by: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

#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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1015
        • Unisanté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the period that the subject is considered as COVID-19-positive: Average of 11 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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)
During the period that the subject is considered as COVID-19-positive: Average of 11 days
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
During the period that the subject is considered as COVID-19-positive: Average of 11 days
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
During the period that the subject is considered as COVID-19-positive: Average of 11 days
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.
During the period that the subject is considered as COVID-19-positive: Average of 11 days
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
During the period that the subject is considered as COVID-19-positive : Average of 11 days
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
During the period that the subject is considered as COVID-19-positive : Average of 11 days
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)
During the period that the subject is considered as COVID-19-positive: Average of 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Blaise Genton, MD-PhD, Unisanté
  • Principal Investigator: Mary-Anne Hartley, MD, PhD MPH, Unisanté

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Unisante

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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