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-GB
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 13 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 within 2 weeks 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