COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04325893

Vincent DUBEE

vincent.dubee@chu-angers.fr

2020-03-30

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - age ≥ 18 years old - symptomatic infection with covid-19 confirmed by positive rt-pcr sars-cov-2 or, failing that, by thorax ct-scan suggesting viral pneumopathy of peripheral predominance in a clinically significant context. - diagnosis in the previous two calendar days or, for an asymptomatic patient at the time of virological diagnosis, onset of symptoms in the previous two calendar days. - patient having at least one of the following risk factors for developing complications: - age ≥75 years old - age between 60 and 74 years old and presence of at least one comorbidity among the following: obesity (body mass index ≥ 30 kg/m²), arterial hypertension requiring treatment, diabetes mellitus requiring treatment - need for supplemental oxygen to reach a peripheral capillary oxygen saturation of more than 94% (spo2 > 94%), or a ratio of partial oxygen pressure to the fraction of inspired oxygen less than or equal to 300 mmhg (pao2/fio2 ≤ 300 mmhg). - patient affiliated to a social security scheme. - written and signed consent of the patient or a relative or emergency inclusion procedure. exclusion criteria - last rt-pcr negative for sars-cov-2 - peripheral capillary oxygen saturation less than or equal to 94% (spo2 ≤ 94%) despite oxygen therapy greater than or equal to 3 l/min (> 3 l/min) - organ failure requiring admission to a critical or intensive care unit. - comorbidity that is life threatening in the short-term (life expectancy < 3 months) - any reason that makes patient follow-up throughout the study impossible - current treatment with hydroxychloroquine - absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, retinopathy, concomitant treatment with risk of ventricular disorders, particularly torsades de pointe, known deficit of glucose-6-phosphate dehydrogenase, porphyria) - hypokalaemia < 3.5 mmol/l - corrected qt prolongation (qtc ≥ 440 ms in men and 460 ms in women). - child-pugh's class c liver cirrhosis - chronic kidney failure with estimated gfr ≤ 30 ml/min, or ≤ 40 ml/min in patients with concomitant treatment with azithromycin - women who are pregnant, breastfeeding, or parturient

None

2

University Hospital, Angers

18

None

France;Monaco

Moderate disease at enrollment

3: Moderate disease at enrollment

259

Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]