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HYCOVID: Hydroxychloroquine in COVID-19
NCT04325893Phase 3
Key facts
- Status
- Terminated
- Start
- Apr 2020
- Primary completion
- Jun 2020
- Countries
- 2
- Sponsor
- Centre Hospitalier Universitaire d'Angers
- Modality
- Small Molecules
- Drugs
- hydroxychloroquine
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing Hydroxychloroquine with Placebo (2 arms). Primary endpoint: Number of death from any cause, or the need for intubation and mechanical ventilation at Day 14. Started Apr 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydroxychloroquine
Hydroxychloroquine 400 mg bid on Day 0, then 200 mg bid for 8 days.
Placebo
Matching placebo administered on the same schedule.
03
Who it enrols
Adult patients with symptomatic COVID-19 confirmed by PCR or CT, diagnosed within 2 days, with risk factors for complications (age >= 75, or 60-74 with comorbidities, or oxygen requirement), excluding those with severe organ failure or contraindications to hydroxychloroquine.
04
Endpoints
Primary
Number of death from any cause, or the need for intubation and mechanical ventilation
Secondary
Number of death from any cause, or the need for intubation and mechanical ventilation
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19
Number of all-cause mortality
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples
The rate of venous thromboembolic events
Rate of severe adverse events
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