Covid-19 Living Data

Trial NCT04332835
Publication Rojas M, BMC Infect Dis (2022) (published paper)
Dates: 2020-08-08 to 2020-11-13
Funding: Mixed (Universidad del Rosario, IDCBIS (Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud), ISA Group and Suramericana.)
Conflict of interest: Yes

Methods
	RCT Blinding: single blinding
	Location : Multicenter / Colombia Follow-up duration (days): 28
Inclusion criteria	Signed informed consent Aged at least 18 years COVID-19 diagnosis based on reverse transcriptase-polymerase chain reaction (RT-PCR) testing Hospitalized patients Sequential Organ Failure Assessment score (SOFA) < 6 Severe cases according to Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7). Severe COVID-19 was defined as respiratory distress with the following criteria: ≥ 30 breaths/minute in a resting state, oxygen saturation of 90% or less on room air, or arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) of 300 or less.
Exclusion criteria	Pregnancy or breastfeeding Patients with prior allergic reactions to transfusions Critically ill patients in an intensive care unit (ICU): patients with requirement of ICU defined by the clinician, requirement of vasopressors, or mechanical ventilation Patients with surgical procedures in the last 30 days Subjects with active treatment for cancer (i.e., radiotherapy or chemotherapy) Diagnosed HIV in subjects with viral failure (i.e., detectable viral load > 1000 copies/mL, two consecutive viral load measurements within a 3-month interval, with medication adherence between measurements after at least six months of starting a new regimen of antiretrovirals) Subjects with a confirmed infection that explains clinical manifestations End-stage kidney disease (i.e., glomerular filtration rate < 15 ml/min/1.73 m2) Child–Pugh C stage liver cirrhosis High cardiac output diseases Autoimmune diseases or Immunoglobulin A nephropathy Subjects not willing to sign a written informed consent.
Interventions
	Treatment Convalescent plasma 250 mL per transfusion, total 500 mL within 48 hours, infusion rate 3 mL/min for 6 hours
	Control Standard care
Participants
	Randomized participants : Standard care=51 Convalescent plasma=50
	Characteristics of participants N= 101 Mean age : NR 64 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register 1) Change in Viral Load [ Time Frame: Days 0, 4, 7, 14 and 28 ] Copies of COVID-19 per ml; 2) Change in Immunoglobulin G COVID-19 Titers [ Time Frame: Days 0, 4, 7, 14 and 28 ] Immunoglobulin G COVID-19 antibodies.
	In the report (1) Reduction of viral load; (2) Increase in titers of IgG and IgA for SARS-CoV-2 at 28 days of follow up
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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 prospective study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Adverse events and serious adverse events were not reported in the registry but safety is in the title of the study. The study (n=101) achieved the target sample size (n=80) specified in the trial registry.