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

COVID-19 Clinical Trial

— #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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04385264
• Other study ID #: Unisante
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 800
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
• Mannitol
Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD

Locations

Country	Name	City	State
Switzerland	Unisanté	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of poor outcomes (in index cases)	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	Secondary household attack rate (in household contacts)	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
Secondary	Subjective disease severity (in index cases)	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
Secondary	Rate of acute respiratory distress syndrome (in index cases)	As recorded during hospitalisation	During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary	Severity of radiological lung pathology (in index cases)	Measured with lung ultrasound, CT or x-ray	During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary	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.	During the period that the subject is considered as COVID-19-positive: Average of 11 days
Secondary	Safety: Unintended toxic HCQ accumulation (in index cases)	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
Secondary	Safety: Adverse events (in index cases)	Ambulatory ECG and intensive monitoring for adverse events	During the period that the subject is considered as COVID-19-positive : Average of 11 days
Secondary	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)	During the period that the subject is considered as COVID-19-positive: Average of 11 days