Publication 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
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.|
300 mL 2 IV infusions 48 hours apart
Standard care ( / )
Definition of Standard care: The SOC for COVID-19 was at the discretion of the treating physicians. The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed. Remdesivir was not available in Brazil during the trial period.
160 participants (n1=80 / n2= 80)
|Characteristics of participants|
Mean age : 58.3
Severity : Mild: n=1 / Moderate: n=39/ Severe: n=52 Critical: n=68
|In the register|
Clinical improvement [ Time Frame: 28 days ]
|In the report|
Proportion of patients with clinical improvement 28 days after enrolment.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
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.