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 ( / ) Definition of Standard care: The included patients, whether in CP or control group, were exactly on the same protocol of therapy [hydroxychloquine 200 mg twice per day for at least 10 days + azithromycin once 500 mg/day loading dose, followed by 250 mg once per day for 5 days + oxygen therapy + methylprednisolone 40 mg per day after admission to RCU). | |
| Participants | |
| Randomized 49 participants (n1=21 / n2= 28) | |
| Characteristics of participants N=49 Mean age : 51.2 * males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=* | |
| 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 stated NR |
| 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. |