Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patients

Phase 1

• Conditions: Coronavirus infection; MedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001270-29-FR
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Participants must be hospitalized with illness consistent with COVID-19 pneumonia by chest imaging and/or clinical examination and with moderate to severe disease
- Laboratory-confirmed SARS-CoV-2 infection
- Onset of COVID-19 symptoms =5 days before randomization
- Women of childbearing potential must have a negative highly sensitive pregnancy test at screening and should agree to use an acceptable contraceptive method
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

- Unlikely to survive for >48 hours from screening
- Participants with critical disease or multi-organ failure
- Any contraindication to HCQ or intolerance to HCQ
- Any medical condition or concomitant therapy that may put the particpants at risk if they are treated with HCQ
- Pregnant or breastfeeding women
- Use of antiarrhythmic medications and medications known to prolong QT interval or cause Torsades de Pointes (TdPs)
- Participants with history of congenital or acquired long QT, arrhythmia, family history of long QT or sudden cardiac death, or any other cardiac condition that, by the judgement of the Investigator, would put the patient at higher risk for QTc prolongation or sudden cardiac death
- Participants with the following ECG findings at screening: QTcF >470 msec for women or >450 msec for men or heart rate <50 beats/minute
- Participants with known glucose-6-phosphate dehydrogenase (G6PD) deficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified