Trial NCT04375098
Publication Balcells M, PLoS Med, 2021 (published paper)
Dates: 2020-05-10 to 2020-07-18
Funding: Public/non profit (Fondo de Adopción Tecnológica SiEmpre, SOFOFA Hub, and Ministerio de Ciencia, Tecnología, Conocimiento e Innovación, Chile)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Chile Follow-up duration (days): 30 | |
| Inclusion criteria | (1) patients over 18 years old;
(2) hospitalized, COVID-19 symptoms present at enrollment and confirmed with a positive SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) in nasopharyngeal swab or, pending PCR result but imaging consistent with COVID-19 pneumonia and confirmed COVID-19 close-contact; (3) ≤7 days from COVID-19 symptoms onset to enrollment; (4) a CALL score ≥ 9 points at enrollment (predicts high-risk of progression into respiratory failure, based on age, comorbidities, lactate dehydrogenase (LDH) and lymphocyte count); (5) Eastern Cooperative Oncology Group (ECOG) performance status before SARS-CoV-2 Inclusion criterion number 2 considered initially only SARS-CoV-2 confirmed PCR positive infections. Based on the 24- to 48-hour delays for PCR results in the peak of the pandemic, this criterion was modified after the trial initiation to allow the inclusion of patients with pending PCR test results. All the patients enrolled with pending PCR results (n = 2) had subsequently confirmed real-time PCR SARS-CoV-2 infection. infection 0-2. |
| Exclusion criteria | (1) PaO2/FiO2<200 or need for mechanical ventilation at enrollment;
(2) coinfection with other relevant respiratory pathogens on admission; (3) pregnancy or lactation; (4) known IgA Nephropathy or IgA deficiency; (5) previous immunoglobulin or plasma administration within the last 60 days; (6) previous severe transfusion reactions; (7) do not resuscitate indication; (8) participating in another COVID-19 interventional study; and (9) patients that under investigator criteria had any condition that made them unsuitable for study participation. |
| Interventions | |
| Treatment
Early Convalescent plasma Two 200 mL transfusion with the second transfusion administered 24 hours after the first dose |
|
| Control
Deferred Convalescent plasma (200 ml) Duration : 2 days | |
| Participants | |
| Randomized 58 participants (n1=28 / n2= 30) | |
| Characteristics of participants N=58 Mean age : 65.7 29 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=31 Critical: n=0 | |
| Primary outcome | |
| In the register Percentage Mechanical Ventilation, hospitalization longer than 14 days or death during hospitalization | |
| In the report Composite of mechanical ventilation, hospitalization >14 days or in-hospital death. | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 |
High |
| General comment |
In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size (n=58). There is no change from the trial registration in the intervention and control treatments, nor the primary outcome. There were some discrepancies between some secondary outcomes stated in the registry versus the report.
On December 14th,2020, we received additional information from authors on this study, we updated the study results based on authors reply. The study was updated on March 25th, 2021 after publication of the study report. |