Covid-19 Living Data

Trial NCT04344730 ; EudraCT 2020-001457-43
Publication COVIDICUS - Bouadma L, JAMA Intern Med (2022) (published paper)
Dates: 2020-04-10 to 2020-11-30
Funding: Mixed (Programme Hospitalier de Recherche Clinique, French Ministry of Health ; Vygon provided continuous positive airway pressure kits for some study centers.)
Conflict of interest: Yes

Methods
	RCT Blinding: quadruple blinding
	Location : Multicenter / France Follow-up duration (days): 60
Inclusion criteria	Adults aged at least 18 years admitted to an ICU within the last 48 hours confirmed or highly suspected COVID-19 AHRF (defined as arterial partial pressure of oxygen, [PaO2] <70 mm Hg, transcutaneous oxygen saturation as measured by pulse oximetry [SpO2] <90% on room air, tachypnea with >30 breaths/min, labored breathing, respiratory distress, or need for O2 flow ≥6 L/min) could receive any available treatment targeting COVID-19. Those with ongoing invasive mechanical ventilation (IMV) at inclusion or with anatomical factors precluding the use of nasal cannula, hypercapnia indicating noninvasive ventilation (PaCO2 ≥50 mm Hg), or intolerance at admission to any of the oxygenation strategies, ie, the IMV population, were only eligible to the dexamethasone randomization.
Exclusion criteria	Decision to limit life-sustaining treatment corticosteroid therapy of 0.5 mg/kg/d or more of prednisone equivalent for 3 weeks or longer active un-treated bacterial, fungal, or parasitic infection hypersensitivity to dexamethasone.
Interventions
	Treatment DEX low dose 6 mg/day intravenously for 100 days (or placebo prior to RECOVERY trial results communication)
	Control DEX high dose 20 mg/day intravenously on days 1-5, then 10 mg/day intravenously on days 6-10
Participants
	Randomized participants : DEX low dose=277 DEX high dose=273
	Characteristics of participants N= 550 Mean age : NR 414 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=448 Critical: n=98 Number of vaccinated participants: 0
Primary outcome
	In the register The time-to-death from all causes [Time Frame: day-60] ; The time to need for mechanical ventilation (MV) [Time Frame: day-28.]
	In the report Time-to-death from all causes up to day 60 ; time to IMV criteria fulfillment within the first 28 days
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
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 published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. This is a factorial trial design with a 2x3 randomization for a 2nd intervention as well based on type of oxygen therapy intervention. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 550) achieved its target sample size (n = 550). 37/276 participants in the low-dose arm were randomized prior to a protocol amendment and did not receive dexamethasone as a trial intervention because the pre-amendment comparison was high-dose dexamethasone versus placebo.