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Table 1 Ongoing randomised controlled trials of convalescent plasma in COVID-19 illness assessed using the PICO framework. These RCTs were identified in a recent Cochrane review by Valk et al. [4]. Participants: We report the setting (severely ill/critically ill versus general wards). In high-risk non-ventilated patients (high inspired oxygen, and/or non-invasive ventilation), this could reduce the need for mechanical ventilation. In ventilated patients, this may translate into improved mortality and reduced length of critical care stay. Intervention: For intervention, we report the description of convalescent plasma volume and titres if highlighted. In SARS-1 patients, convalescent plasma improved outcomes when administered within 14 days of illness onset and in those without detectable antibodies against coronavirus at the time of infusion. Only four studies use a predetermined neutralising titre cutoff with convalescent plasma. Comparator: We highlight whether the ordinary plasma or standard of care was chosen. In five RCTs, the comparator is ordinary plasma transfusion, which may enhance blinding but comes with risks of blood product. When summarising the ongoing current trials, it is unlikely that an efficacy signal would be generated from many of these trials due their methodological limitations (such as small sample size) and biological limitations (such as lack of pre-defined cutoff for neutralising antibody titres). For outcome, we list only the primary outcome for the trial. We also highlight the proposed sample size in the trial.

From: Convalescent plasma to treat critically ill patients with COVID-19: framing the need for randomised clinical trials

Trial ID [country] Participants Intervention Comparator Outcome N
ChiCTR2000029757 [China] Severely ill/critically ill Volume = NR Standard of care 2-point improvement in clinical symptoms in a 6-point scale 200
Titres = NR
ChiCTR2000030010 [China] Severely ill adults less than 70 years Volume = NR Ordinary plasma 2-point improvement in clinical symptoms in a 6-point scale 100
Titres = NR
ChiCTR2000030179 [China] Severely ill adults less than 66 years Volume = NR Standard of care Cure rate 100
Titres = NR Mortality
ChiCTR2000030627 [China] Severely ill/critically ill Volume = NR Standard of care Temperature control 30
Titres = NR
ChiCTR2000030702 [China] Hospitalised patients Volume = NR Standard of care Time to clinical recovery after randomisation 50
Titres = NR
ChiCTR2000030929 [China] Severely ill adults less than 70 years Volume = NR Ordinary plasma 2-point improvement in clinical symptoms in a 6-point scale 60
Titres = NR
EUCTR2020-001310-38 [Germany] Severely ill/critically ill adults less than 75 years Volume = up to 960 ml Standard of care Composite endpoint:
- Survival and no longer fulfilling criteria of severe COVID-19 within 21 days after randomisation
120
Titres = NR
IRCT20200310046736N1 [Iran] Adult (20 to 45 years) Volume = 800 ml Standard of care N/A 45
Titres = NR
IRCT20200404046948N1 [Iran] Severely ill/critically ill adults less than 70 years Volume = up to 500 ml Standard of care 2-point improvement in clinical symptoms at 14 days 60
Titres = NR
IRCT20200409047007N1 [Iran] Critically ill adults 50–75 years with Pao2/FIO2 ratio < 300; normal IgA level and within 7 days of admission Volume = up to 500 ml Standard of care 1-month mortality 35
Titres = NR
IRCT20200413047056N1 [Iran] Severely ill/critically ill adults less than 50 years Volume = up to 400 ml Standard of care or intravenous immunoglobulin NR 15(1:1:1) 3-arm study
Titres = NR
NCT04332835 [Columbia] Hospitalised adults less than 60 years Volume = up to 500 ml Hydroxychloroquine Change in viral load 60
Titres = NR Change in antibody titres
Coadministration of hydroxychloroquine
NCT04333251 [USA] Hospitalised adults Volume = 2 doses Standard of care Reduction in oxygen and ventilation support 115
Titres = > 1:64
NCT04342182 [Netherlands] Hospitalised adults Volume = up to 300 ml Standard of care Mortality 426
Titres = NR
NCT04344535 [USA] Hospitalised adults Volume = up to 550 ml Standard plasma Ventilator-free days up to day 28 500
Titres = > 1:320
NCT04345289 [Denmark] Hospitalised adults with pneumonia Volume = 600 ml Multiple interventions; adaptive platform trial Composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days 1500
Titres = NR 1:1:1:1:1:1
NCT04345523 [Spain] Hospitalised adults with pneumonia Volume = 800 ml Standard of care WHO ordinal scale 278
Titres = NR
NCT04345991 [France] Mild severity as described in the WHO scale, within 8 days Volume = 800 ml Standard of care Survival without needs of ventilator utilisation or use of immunomodulatory drugs at 14 days 120
Titres = NR
NCT04346446 [India] Severely ill/critically ill adults less than 65 years Volume = up to 600 ml Standard of care Proportion of patients remaining free of mechanical ventilation at 7 days 40
Titres = NR
NCT04348656 [Canada] Hospitalised adults receiving supplemental oxygen Volume = up to 500 ml Standard of care Intubation or hospital mortality within 30 days 1200
Titres = NR
NCT04355767 [USA] Adults requiring emergency department evaluation Volume = up to 600 ml Standard plasma Time to disease progression at 15 days 206
Titres = > 1:80
NCT04356534 [Bahrain] Adults > 21 years with severely ill with radiological evidence of pneumonia Volume = up to 600 ml Standard of care Requirement for invasive ventilation 40
Titres = > 1:80
NCT02735707 [Multinational] Severely ill/critically ill adults Volume = up to 600 ml Multiple interventions; adaptive platform trial Days alive and outside of ICU at 21 days 7100 platform
Titres = > 1:64