COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001270-29/CZ

sanofi-aventis, s.r.o. - www.sanofi.cz

cz-info@sanofi.com

2020-03-30

Terminated

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

-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

-Unlikely to survive for >48 hours from screening - Participants with critical disease or multiorgan 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

2

sanofi-aventis recherche & développement

18

100

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

75

1. Phase 2: Change in SpO2/FiO2 ratio from baseline to Day 15. 2. Phase 3 (may be reassessed after review of phase 2): Change in SpO2/FiO2 ratio from baseline to Day 15

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2/Phase 3

[{"arm_notes": null, "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]