Trial NCT04346446
Publication Bajpai M, medRxiv, 2020 (preprint)
Funding: No specific funding (None)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / India Follow-up duration (days): 28 | |
Inclusion criteria | SARS-CoV-2 infection (positive by real-time PCR assay) patient, with severe COVID-19 [respiratory rate (RR) 30/min, oxygen saturation level less than 93% in resting state, the partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) 300 mmHg, lung infiltrates >50% within 24 to 48 hours]. |
Exclusion criteria | Failure to obtain informed consent, patients less than 18 years or more than 65 years of age, those with co-morbid conditions (cardiopulmonary disease-structural or valvular heart disease, coronary artery disease, COPD, chronic liver disease, chronic kidney disease), patients presenting with multi-organ failure or on mechanical ventilation, pregnant females, individuals with HIV, viral hepatitis, cancer, morbid obesity with a BMI>35 kg/m2, extremely moribund patients with an expected life expectancy of <24 hours, hemodynamic instability requiring vasopressors, previously known history of allergy to plasma, or a PaO2/FiO2 ratio less than 150. |
Interventions | |
Treatment
Convalescent plasma 250 ml IV once a day for 2 consecutive days |
|
Control
Fresh frozen plasma (250 ml) Duration : 2 days | |
Participants | |
Randomized 31 participants (n1=15 / n2= 16) | |
Characteristics of participants N=31 Mean age : 48.2 22 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=29 Critical: n=0 | |
Primary outcome | |
In the register Proportion of patients remaining free of mechanical ventilation in both groups [ Time Frame: Day 7 ] | |
In the report Proportion of patients remaining free of mechanical ventilation in both groups on day seven | |
Documents available |
Protocol NR Statistical plan NR 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 |
Some concerns |
General comment | In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Although the article states that supporting information files include the study protocol and statistical analysis plan, these were not available at time of data extraction and assessment of risk of bias. There were no substantive differences between the trial registry and the pre-print article in study population, procedures and outcomes. There was slight inconsistency between registry and article in dosage of convalescent/frozen plasma. No scientific sample size calculation was done as it was a pilot trial only. |