Trial NCT04344535
Publication Bennett-Guerrero E, Crit Care Med, 2021 (published paper)
Funding: Private (Stony Brook Medicine )
Conflict of interest: No
| Methods | |
| RCT Blinding: triple blinding | |
| Location :
Single center / USA Follow-up duration (days): 90 | |
| Inclusion criteria | Adult patients hospitalized with a confirmed diagnosis of COVID-19 infection from SARS-CoV-2 RT-PCR testing. |
| Exclusion criteria | Contraindication to transfusion or history of prior reactions to transfusion blood products; receipt of pooled (polyclonal) immunoglobulin or any intravenous polyclonal immunoglobulin (IVIG) in past 30 days; female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period; in the treating physician’s opinion, the patient is unable to tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit); unable to be randomized within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer). |
| Interventions | |
| Treatment
Convalescent plasma 2 units (approximately 480 mL) IV over 2-8 hours once-off |
|
| Control
Standard plasma ( / ) | |
| Participants | |
| Randomized 74 participants (n1=59 / n2= 15) | |
| Characteristics of participants N=74 Mean age : 66.4 44 males Severity : Mild: n=21 / Moderate: n=34/ Severe: n=5 Critical: n=14 | |
| Primary outcome | |
| In the register Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. | |
| In the report The total number of ventilator-free days from randomization to day 28 with ventilator-free days was defined as the total number of calendar days or proportions of calendar days during the first 28 days after randomization. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated No |
| 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 trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. A number of outcomes were not included in the registry, but were reported in the article. Enrollment in the trial was stopped after FDA granted EUA for CP since it seemed unlikely that patients would wish to participate in a randomized trial for an “approved therapy.” Consequently, the trial’s target sample size (n = 500) was not reached (n = randomized = 74). |