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Hydroxychloroquine and Azithromycin for Severe COVID-19
NCT04335552Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2020
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- Duke University
- Modality
- Small Molecules
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, open-label trial of hydroxychloroquine and azithromycin in coronavirus disease 2019 (COVID-19) (4 arms), sponsored by Duke University. Primary endpoint: World Health Organization (WHO) Ordinal Scale at Day 14. Started Apr 2020; status: terminated.
02
Design
4 arms- Study design
- RandomizedOpen-label
Standard of care
Standard of care alone
Standard of care plus hydroxychloroquine
Standard of care plus hydroxychloroquine for 5 days
Standard of care plus azithromycin
Standard of care plus azithromycin for 5 days
Standard of care plus hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine plus azithromycin for 5 days
03
Who it enrols
Hospitalized patients aged 12 or older with confirmed SARS-CoV-2 infection and symptoms/hypoxia, excluding those with G6PD deficiency, long QT syndrome, or recent hydroxychloroquine use.
04
Endpoints
Primary
World Health Organization (WHO) Ordinal Scale
Secondary
All-Cause Mortality
Number of Days on Mechanical Ventilation
Progression to Requiring Mechanical Ventilation
World Health Organization (WHO) Ordinal Scale
Hospital Length of Stay
All-cause Study Medication Discontinuation
Severe Adverse Events
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