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

NCT04385264 | Withdrawn Phase 2 DMC

• 1 other identifier: Unisante
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Secondary household attack rate (in household contacts)

  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)

  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)

  During the period that the subject is considered as COVID-19-positive: Average of 11 days

• Severity of radiological lung pathology (in index cases)

  During the period that the subject is considered as COVID-19-positive: Average of 11 days

• Objective disease severity (in index cases)

  During the period that the subject is considered as COVID-19-positive: Average of 11 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (Mannitol), oral capsules Day 0: 4 capsules PO OD Days 1-5: 2 capsules PO OD

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)

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

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

Also known as: Plaquenil, HCQ

Hydroxychloroquine

Mannitol DRUG

Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead

Study Sites (1)

Unisanté

Lausanne, Canton of Vaud, 1015, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Mannitol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Blaise Genton, MD-PhD

  Unisanté

  PRINCIPAL INVESTIGATOR

• Mary-Anne Hartley, MD, PhD MPH

  Unisanté

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 12, 2020
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CH (1)