Covid-19 Living Data

Trial NCT04369469
Publication NCT04369469, Unpublished (2022) (results posted on registry)
Dates: 2020-05-10 to 2021-01-13
Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / France, Japan, Spain, UK, USA Follow-up duration (days): 90
Inclusion criteria	Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction and/or antibody test) presenting as severe COVID-19 requiring hospitalization Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography or X-ray at Screening or within the 3 days prior to Screening, as part of the participant's routine clinical care Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure or bilevel positive airway pressure) Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug
Exclusion criteria	Participant was not expected to survive for more than 24 hours Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias) Participant had an unresolved Neisseria meningitidis infection Used the following medications and therapies: Current treatment with a complement inhibitor Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1 Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions: Investigational therapies were allowed if received as part of BSC through an expanded access protocol or emergency approval for the treatment of COVID-19. Investigational antiviral therapies (such as remdesivir) were allowed even if received as part of a clinical study Female participants who were breastfeeding or who have a positive pregnancy test result at Screening History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the participant receives vaccination against Neisseria meningitidis
Interventions
	Treatment Ravulizumab A weight-based dose (≥40 to < 60 kg/2400 mg, 60 to < 100 kg/2700 mg, ≥100 kg/3000 mg) IV on Day 1. 600 mg (≥40 to <60 kg) or 900 mg (>60 kg) IV on Day 5 and Day 10. 900 mg IV on Day 15.
	Control Standard care
Participants
	Randomized participants : Standard care=67 Ravulizumab=135
	Characteristics of participants N= 202 Mean age : NR 139 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=* Number of vaccinated participants: NR
Primary outcome
	In the register Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 [ Time Frame: Day 29 ]
	In the report NR
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	This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The study was terminated. According to the registy, "Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021."