Covid-19 Living Data

Trial NCT04547660
Publication PLACOVID - Sekine L, Eur Respir J (2021) (published paper)
Dates: 2020-07-15 to 2020-12-10
Funding: Public/non profit (Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Cultural Floresta, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Brazil Follow-up duration (days): 28
Inclusion criteria	Admitted to the hospital 18 or older positive reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 less than 15 days of initial symptoms onset severe respiratory disease, as defined by the presence of at least one of the following: respiratory rate >30 breaths per minute in room air oxygen saturation (O2) ≤93% in room air arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2)≤300 need for supplemental O2 to maintain O2 saturation >95% need for supplemental O2 by high flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation.
Exclusion criteria	Impossibility for any reason to perform the first plasma infusion within 14 days of the onset of symptoms use of immunosuppressive drugs for other non-COVID-19 underlying diseases in the last 30 days before enrolment pregnancy history of serious adverse reactions such as transfusion anaphylaxis disagreement of attending physician and participation in other interventional randomised clinical trials.
Interventions
	Treatment Convalescent plasma 300 mL 2 IV infusions 48 hours apart
	Control Standard care
Participants
	Randomized participants : Convalescent plasma=80 Standard care=80
	Characteristics of participants N= 160 Mean age : NR 93 males Severity : Mild: n=1 / Moderate: n=39 / Severe: n=52 Critical: n=68 Number of vaccinated participants: NR
Primary outcome
	In the register Clinical improvement [ Time Frame: 28 days ]
	In the report Proportion of patients with clinical improvement 28 days after enrolment.
Documents available	Protocol Yes. In English Statistical plan Yes 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 protocol and statistical analysis plan and retrospective registry were used in data extraction and assessment of risk of bias. There were no substantive differences in population, procedures, interventions or primary outcome and secondary outcomes between the registry and protocol and the published article. The primary outcome was changed after start of recruitment, but with only 8 patients recruited and with appropriate approval from the national and local ethics committees. Although the trial was retrospectively registered during its conduct, the protocol was prospective and the final version reports no other substantive changes to outcomes. The study achieved its target sample size. This study was updated on November 11th, 2021 with data from contact with authors.