Trial *
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

Methods
RCT
Location : Multicenter / Iraq
Follow-up duration (days): *
Inclusion criteria
  • Age ≥18 years
    Affected by pneumonia
    SpO2 <90% in resting state
    First 3 days in RCU receiving O2 or on ventilators.
Exclusion criteria
  • Previous allergic history to plasma or its ingredients such as sodium citrate
    Cases with serious general conditions, such as severe organ dysfunction, that were not suitable for transfusion
    Very late stage of the ARDS where CP has proved to be of low therapeutic benefit.
Interventions
Treatment
Convalescent plasma
400 ml IV infusion once-off over 2 hours
Control
Standard care

Participants
Randomized
participants :
Standard care=28
Convalescent plasma=21
Characteristics of participants
N= 49
Mean age : NR
0 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
NR
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.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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
*
General comment 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.