Covid-19 Living Data

Trial NCT04325893
Publication Dubee V, Clin Microbiol Infec (2021) (published paper)
Dates: 2020-04-01 to 2020-05-26
Funding: Public/non profit (French Ministry of Health, Pays de la Loire region, Angers Loire Metropole conurbation)
Conflict of interest: Yes

Methods
	RCT Blinding:
	Location : Multicenter / France, Monaco Follow-up duration (days): 28
Inclusion criteria	1) Men and non-pregnant women aged ≥ 18 years old 2) Diagnosis of COVID-19 confirmed by positive RT-PCR SARS-CoV-2 within 2 days were assessed for eligibility or by thorax CT-scan showing typical features of COVID-19. At least one of the following risk factors for worsening: (i) need for supplemental oxygen to reach a peripheral capillary oxygen saturation of more than 94% (SpO2 >94%) or a ratio of oxygen partial pressure to fractional inspired oxygen less than or equal to 300 mmHg (PaO2/FiO2 ≤300 mmHg) (ii) age ≥75 years (iii) age between 60 and 74 years and presence of at least one of the following comorbidities: obesity (body mass index ≥30 kg/m²), arterial hypertension requiring treatment, or diabetes mellitus requiring treatment.
Exclusion criteria	1) Patients requiring more than 3 L/min of oxygen to reach an SpO2 of 94% 2) Those with a clinical condition necessitating admission to intensive care unit 3) A negative SARS-CoV-2 RT-PCR 4) A short-term life-threatening comorbidity (life expectancy <3 months) 5) Any condition contraindicating hydroxychloroquine treatment (known hypersensitivity or allergy, retinopathy, concomitant treatment associated with a risk of ventricular arrhythmias, use of medications that are contraindicated with hydroxychloroquine and cannot be replaced or stopped during the trial) 6) Conditions associated with an increased risk of adverse event
Interventions
	Treatment Hydroxychloroquine 200 mg orally twice daily for 8 days.
	Control Placebo
Participants
	Randomized participants : Hydroxychloroquine=125 Placebo=125
	Characteristics of participants N= 250 Mean age : NR 121 males Severity : Mild: n=96 / Moderate: n=151 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment. [ Time Frame: Day 14 ]
	In the report Composite of death and the need for invasive mechanical ventilation within 14 days following randomization
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the trial registry, protocol, statistical analysis plan and supplementary materials were used in data extraction and assessment of risk of bias. The trial did not reach its proposed sample size as it was terminated due to a low inclusion rate in the context of the slowdown of the pandemic in France, shortly after being suspended due to reports of hydroxychloroquine toxicity in other trials. There were no substantive differences between the pre-print article and the trial registry, protocol, statistical analysis plan and supplementary materials in study procedures, treatments or outcomes. On 13th of April ,2021, this study was updated based on the published report.