Covid-19 Living Data

Trial NCT04333420, EudraCT 2020-001335-28
Publication PANAMO - Vlaar APJ, Lancet Respir Med (2022) (published paper)
Dates: 2020-10-01 to 2021-10-04
Funding: Mixed (This trial was funded by InflaRx and partly funded by the German Federal Government. The funder of the study had a role in study design, data collection, data analysis, data interpretation, and writing of the report.)
Conflict of interest: Yes

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / Netherlands (37%), Brazil (20%), Mexico (10%), France (9%), Russia (6%), Germany (6%), Belgium (4%), Peru (4%), and South Africa (3%) Follow-up duration (days): 60
Inclusion criteria	Aged 18 years or older Were receiving invasive mechanical ventilation within 48 h before the first infusion of study medication Had a PaO2/FiO2 ratio of 60–200 mm Hg Confirmed SARS-CoV-2 infection in the past 14 days
Exclusion criteria	Invasive mechanical ventilation for more than 48 h at the first infusion of study medication Expected stop of invasive ventilation or extubation within the next 24 h History of renal replacement therapy 14 days before random assignment Severe chronic obstructive pulmonary disease Not approved or investigational treatment in the past 7 days Cytokine adsorption therapy in the past 3 days Known hypersensitivity to vilobelimab Pregnancy Organ or bone marrow transplant in past 3 months Cardiopulmonary mechanical resuscitation in the past 14 days Anticancer therapy for haemato-oncological disease in the past 4 weeks Active malignant disease Severe congestive heart failure Chronic liver disease A moribund state Expected death within 24 h of random assignment Participating in or has participated in other investigational interventional studies (drug or device) within the last 7 days before randomization
Interventions
	Treatment Vilobelimab 800 mg IV for a maximum of 6 doses, as one dose per day on days 1, 2, 4, 8, 15, and 22
	Control Placebo
Participants
	Randomized participants : Vilobelimab=178 Placebo=191
	Characteristics of participants N= 369 Mean age : NR 252 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=0 Critical: n=369 Number of vaccinated participants: NR
Primary outcome
	In the register Mortality [Time Frame: Day 28]: 28-day all-cause mortality
	In the report All-cause mortality at 28 days in the full analysis set
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: N
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 and its supplement, the protocol, SAP and study registry were used in data extraction and risk of bias assessment. The study (N=369) achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Adverse and serious adverse events were classified as "treatment-emergent" in the report.