Publication Rasheed A, Le Infezioni in Medi (2020) (published paper)
Funding: Public/non profit (Karkh health directorate in Baghdad; Alkharkh General Directorate of Health, Alkadymia, Baghdad )
Conflict of interest: No
Multicenter / Iraq |
Follow-up duration (days): *
400 ml IV infusion once-off over 2 hours
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
|In the register|
|In the report|
The end points for the current study were: First, the safety of the CP therapy within the first 3 hours post-transfusion by mainly monitoring the allergic reaction to CP. Second, the duration, in days, for the patients to convert to SARS-CoV-2 RNA-negative along with improvement in the signs and symptoms of the critical infection, namely relief of severe dyspnea, no need for ventilators or oxygen therapy, declin- ing in fever if any, declining in respiratory rate to less than 30/min, and increased oxygen satura- tion to more than 93% at rest, so patients can be discharged from RCU to the infectious disease ward; this duration is named the Recovery Time from Critical Illness (RTCI). Third, the survival or death of the patients.
Data-sharing willing stated in the publication:
|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
This study is pending contact with authors due to lack of information on outcome timepoints, and overall follow-up.
Only the published article was used in data extraction and assessment of risk of bias. No trial registry, study protocol or statistical analysis plan was available. The sample size appears to have been determined by the availability of convalescent plasma. No follow up timepoint was reported. There was no explicit primary outcome defined nor an outcome that was used for the sample size calculation.