COVID-19Phase 2/3#StayHomeNCT04385264
#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19
A Phase 2/3 study testing Hydroxychloroquine and Mannitol in people with COVID-19, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2022to Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Diabetes
- Cardiovascular disease (History of infarction OR peripheral arteriopathy OR cerebrovascular accident OR cardiac insufficiency)
- Chronic respiratory disease
- Immunosuppression
- Cancer
- Obesity (BMI>40)
- Age >1 year old AND
- Living in same household as index case during self-isolation
Who cannot join
- 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
Show all 17Show fewer
- 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
- History of laboratory-confirmed SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Mannitol
- Keywords
- Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil, HCQ
Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
MannitolDrug
Also called Placebo
Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD Receives: Drug: Mannitol |
| Hydroxychloroquine | Experimental | Hydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily) Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of poor outcomes (in index cases)
Proportion of secondary hospitalisations (and their length), ICU admissions (and their length) and deaths.
Measured: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary outcomes (8)
Secondary household attack rate (in household contacts)
Proportion of a household with new seropositivity for SARS-CoV-2
Measured: 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)
An ordinal scale of disease severity using a visual analogue scale (0-10 where 0 is asymptomatic)
Measured: 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)
As recorded during hospitalisation
Measured: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Severity of radiological lung pathology (in index cases)
Measured with lung ultrasound, CT or x-ray
Measured: During the period that the subject is considered as COVID-19-positive: Average of 11 days
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.
Measured: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Safety: Unintended toxic HCQ accumulation (in index cases)
Plasma concentrations of HCQ measured by liquid chromatography-tandem mass spectrometry
Measured: During the period that the subject is considered as COVID-19-positive : Average of 11 days
Safety: Adverse events (in index cases)
Ambulatory ECG and intensive monitoring for adverse events
Measured: 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
Visual analogue scores for social distancing practices (0-5, where 0 is no social distancing at all)
Measured: During the period that the subject is considered as COVID-19-positive: Average of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startJan 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Sufficient number of subjects would probably not reach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blaise Genton, MD-PhD, Principal investigator, UnisantéMary-Anne Hartley, MD, PhD MPH, Principal investigator, Unisanté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385264
- Sponsor's protocol ID
- Unisante
- Acronym
- #StayHome
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2020
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04385264
- Acronym / sponsor ID
- #StayHome / Unisante
- Conditions
- COVID-19
- Keywords
- Hydroxychloroquine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sufficient number of subjects would probably not reach
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: MannitolPlacebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD |
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineHydroxychloroquine 200mg (HCQ, Plaquenil), oral capsules Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 >1 year old AND
Key exclusion criteria (17 listed)
- Allergy to hydroxychloroquine/4-aminoquinilones
- Retinal eye disease
- Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- Weight < 40 kg
- Known porphyria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: Plaquenil, HCQDay 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily) | Drug | Hydroxychloroquine |
| MannitolAlso: PlaceboDay 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
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
Subjective disease severity (in index cases)
Time frame: 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
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
Objective disease severity (in index cases)
Time frame: 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
Safety: Adverse events (in index cases)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blaise Genton, MD-PhD principal investigator
Unisanté
Mary-Anne Hartley, MD, PhD MPH principal investigator
Unisanté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxychloroquine and Mannitol in people with COVID-19, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.