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Table 1 Characteristics of included randomized clinical trials of convalescent plasma treatment in COVID-19

From: Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Trial acronym and/or registration number

Location

Status

Blinding

Control type

N included (N planned)

Mortality %

Planned mortality time pointa

Patient setting

Plasma titer, assay (timing of intervention)

Donor severity (HLA antibody status)

Unpublished

          

LIFESAVER (NCT04374526)

Italy

Recruiting

None

Standard of care

12 (182)

16.67%

28 days

Inpatients with supplemental oxygen

Low titer: ≥ 1:200 S-RBD IgG, EUROIMMUN

(Maximum was =  < 14 days after symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

RECOVER (EUCTR2020-001632-10-DE)

Germany

Recruiting

None

Standard of care

90 (174)

13.33%

28, 56 and 84 days

Inpatients with supplemental oxygen

Confirmed high-titer: ≥ 1:80, neutralizing antibody assay

(No exclusion based on timing of symptom onset)

Mild to severe

(Excluding potentially HLA antibody positive persons)

LACCPT (PACTR202006760881890)

Nigeria

Recruiting

Participant, Care Provider

Placebo (normal saline)

22 (100)

59.09%

3, 5, 7, 9, and 11 days

Inpatients with supplemental oxygen

No minimum cut-off

(Maximum was =  < 14 days after symptom onset)

Mild to severe

(Excluding potentially HLA antibody positive persons)

CPC-SARS (NCT04405310)

Mexico

Recruiting

Participant, Care Provider

Placebo (hartmann plus albumine)

42 (80)

28.57%

15 days

Inpatients with supplemental oxygen

Confirmed high-titer: > 1000 S-RBD IgG, > 1:32 neutralizing, separate in-house assays

(Maximum was > 14 days after symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

NCT04442191

United States

Recruiting

Participant, Care Provider

Placebo (fresh frozen plasma)

14 (50)

7.14%

28 days

Inpatients with supplemental oxygen

Low-titer: S-RBD IgG, Abbott Architect IgG

(No exclusion based on timing of symptom onset)

NA

(Not excluding potentially HLA antibody positive persons)

NCT04385199

United States

Recruiting

None

Standard of care

30 (30)

16.67%

NR

Inpatients with supplemental oxygen

No minimum cut-off

(No exclusion based on timing of symptom onset)

NA

(NA)

NCT04403477 (NCT04403477)b

Bangladesh

Recruiting

None

Standard of care

30 (60)

18.33%

28 days

Inpatients with supplemental oxygen

Low titer: ≥ 1:160 S-RBD IgG, EUROIMMUN

(Maximum was =  < 14 days after symptom onset)

Moderate to severe

(Excluding potentially HLA antibody positive persons)

PLACO-COVID (NCT04428021)

Italy

Active, not recruiting

Participant, Care Provider, Outcomes Assessor

Standard of care

120 (180)c

15.83%

30 days

Inpatients with supplemental oxygen

No minimum cut-off

(No exclusion based on timing of symptom onset)

Mild to severe

(Excluding potentially HLA antibody positive persons)

REMAP-CAP (NCT02735707)

International

Terminated

None

Standard of care

2014 (N/A)

34.26%

90 days

ICU

Confirmed high-titer: ≥ 1:100 neutralizing or equivalent. In the UK: EUROIMMUN S/C ≥ 6

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

ASCOT (NCT04483960)

Australia and New Zealand

Terminated

None

Standard of care

33 (N/A)

9.09%

28 days

Inpatients with or without supplemental oxygen

Confirmed high-titer: ≥ 1:80, neutralizing assay by Walker et al. (2021)

(Maximum was =  < 14 days after symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

Co-CLARITY (NCT04567173)

Philippines

Recruiting

None

Standard of care

25 (136)

0.00%

28 days

Inpatients with or without supplemental oxygen

Low titer: Ortho VITROS S/C ≥ 5

(Maximum was =  < 14 days after symptom onset)

Moderate to severe

(Excluding potentially HLA antibody positive persons)

NCT04528368

Brazil

Recruiting

None

Standard of care

16 (60)

0.00%

7, 10, 14, 21 and 28 days

Inpatients with or without supplemental oxygen

Low titer: ≥ 1:320 S-RBD IgG, in-house assay

(Maximum was =  < 14 days after symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

CAPSID (NCT04433910)

Germany

Recruiting

None

Standard of care

5 (106)

0.00%

21, 35 and 60 days

ICU

No minimum cut-off

(No exclusion based on timing of symptom onset)

NA

(Not excluding potentially HLA antibody positive persons)

PERUCONPLASMA (NCT04497324)

Peru

Recruiting

None

Standard of care

25 (100)

16.00%

30 days

Inpatients with supplemental oxygen

Confirmed high-titer: EUROIMMUN S/C > 5.0

(No exclusion based on timing of symptom onset)

Moderate to severe

(Excluding potentially HLA antibody positive persons)

NCT04332835

Colombia

Completed

Outcome Assessor

Standard of care

100 (92)

8.00%

7, 14 and 28 days

Inpatients with supplemental oxygen

Confirmed high-titer: IgG ≥ 1/3200 and IgA ≥ 1/800 by EUROIMMUN. All transfused plasma presented neutralizing antibodies ≥ 1/256

(No exclusion based on timing of symptom onset)

Moderate to severe

(Excluding potentially HLA antibody positive persons)

CONFIDENT (NCT04558476)

Belgium

Recruiting

None

Standard of care

301 (500)

31.89%

28 and 90 days

ICU

Confirmed high-titer: ≥ 1:320 neutralizing, in-house assay

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

PC/COVID-19 (NCT04366245)

Spain

Completed

None

Standard of care

41 (72)

2.44%

14 and 28 days

Inpatients with supplemental oxygen

Low titer: Vircell SL (Spain) test, correlates to ≥ 1:320 S-RBD IgG

(Maximum was =  < 14 days after symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

COP-COVID-19 (NCT04358783)

Mexico

Recruiting

Participant, Care Provider

Standard of care

31 (30)

35.48%

14 days

Inpatients with supplemental oxygen

Low titer: S/C ≥ 3, Abbott's chemiluminescent microparticle immunoassay for the qualitative detection of IgG

(Maximum was =  < 14 days after symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

NCT04600440

Sweden

Terminated

None

Standard of care

31 (100)

16.13%

90 days

Inpatients with supplemental oxygen

Confirmed high-titer: ≥ 1:40 neutralizing, in-house assay

(No exclusion based on timing of symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

CCAP-2

(NCT04345289)

Denmark

Terminated

Participant, Care Provider, Outcome Assessor

Placebo (normal saline)

144 (1,100)

11.11%

7, 14, 21, 28 and 90 days

Inpatients with or without supplemental oxygen

Other titer leveld

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

Published

          

ChiCTR2000029757

China

Terminated

None

Standard of care

103 (200)

19.42%

28 days

Inpatients with supplemental oxygen

Confirmed high-titer: ≥ 1:640 S-RBD IgG, in-house assay

(NA)

NA

(NA)

NCT04342182

Netherlands

Terminated

None

Standard of care

86 (426)

19.77%

60 days

Inpatients with or without supplemental oxygen

Low titer: ≥ 1:400 S-RBD IgG, assay missing

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

NCT04392414

Russia

Completed

None

Placebo (fresh frozen plasma)

66 (60)

6.06%

30 days

Inpatients with or without supplemental oxygen

Confirmed high-titer: ≥ 1:1000 S-RBD IgG, in-house assay

(Maximum was =  < 14 days after symptom onset)

Moderate to severe

(Not excluding potentially HLA antibody positive persons)

ConPlas-19 (NCT04345523)

Spain

Terminated

None

Standard of care

81 (278)

4.94%

29 days

Inpatients with or without supplemental oxygen

Confirmed high-titer: > 1:80, neutralizing assay

(Maximum was =  < 14 days after symptom onset)

NA

(NA)

PLACID (CTRI/2020/04/024775)

India

Completed

None

Standard of care

464 (452)

14.01%

28 days

Inpatients with supplemental oxygen

No minimum cut-off

(No exclusion based on timing of symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

ILBS-COVID-02 (NCT04346446)

India

Completed

None

Placebo (fresh frozen plasma)

31 (40)

3.23%

28 days

Inpatients with supplemental oxygen

No minimum cut-off

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

NCT04356534

Bahrain

Completed

None

Standard of care

40 (40)

7.50%

28 days

Inpatients with supplemental oxygen

No minimum cut-off

(Maximum was =  < 14 days after symptom onset)

Moderate to severe

(Excluding potentially HLA antibody positive persons)

PLASM-AR (NCT04383535)

Argentina

Completed

Participant, Care Provider

Placebo (normal saline)

333 (333)

11.11%

30 days

Inpatients with or without supplemental oxygen

Confirmed high-titer: ≥ 1:800 S-RBD IgG, COVIDAR IgG test

(No exclusion based on timing of symptom onset)

Mild to moderate

(Excluding potentially HLA antibody positive persons)

PICP19 (CTRI/2020/05/025209)

India

Completed

None

Standard of care

80 (80)

30.00%

30 days

Inpatients with supplemental oxygen

No minimum cut-off

(Maximum was =  < 14 days after symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

NCT04479163

Argentina

Terminated

Participant, Care Provider

Placebo (normal saline)

160 (210)

3.75%

25 days

Outpatients

Confirmed high-titer: > 1:1000 (COVIDAR IgG, Instituto Leloir, Argentina)

(Maximum was =  < 14 days after symptom onset)

NA

(NA)

RECOVERY Trial (NCT04381936)

United Kingdom

Terminated

None

Standard of care

11,558 (N/A)

24.28%

28 days

Inpatients with or without supplemental oxygen

Confirmed high-titer: ≥ 1:100 neutralizing (EUROIMMUN IgG ELISA S/C ≥ 6.0)

(No exclusion based on timing of symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

NCT04359810

United States

Completed

Participant, Outcomes Assessor

Placebo (fresh frozen plasma)

223 (219)

16.59%

28 days

Inpatients with or without supplemental oxygen

Low titer: ≥ 1:400 S-RBD IgG, in-house assay

(No exclusion based on timing of symptom onset)

NA

(NA)

IRCT20200310046736N1e

Iran

Completed

Participant, Outcome Assessor

Standard of care

62 (62)

12.90%

60 days

Inpatients with supplemental oxygen

No minimum cut-off

(Maximum was =  < 14 days after symptom onset)

NA

(Excluding potentially HLA antibody positive persons)

  1. ELISA enzyme-linked immunosorbent assay, IgG immunoglobulin G, S-RBD IgG spike-protein receptor binding domain-specific IgG antibody titer, NA not reported, S/C sample to cutoff ratio
  2. aFor published trials, we report the planned time point (after randomization) stated in the publications and used for our meta-analysis. For unpublished trials, we report the planned time points as reported in the registries and for the meta-analysis, we used the mortality data available at the time-point of the request, which may not reflect the planned time points (or future publications reporting on it)
  3. bNCT04403477 compares two different volumes of plasma (a) 400 mL and (b) 200 mL versus standard of care
  4. cThe multi-arm PLACO-COVID trial includes another experimental arm (N = 60) treated with standard therapy + standard plasma, a treatment not considered in this review
  5. dCCAP-2 initially used a EUROIMMUN cutoff of > 3.0, which was changed to > 3.5 after the March 2021 update of the US FDA emergency use authorization with its new guidance. For this meta-analysis, it is categorized as non-high titer
  6. eIRCT20200310046736N was published after the last literature search on April 8th, 2021. The trial team made us aware of their publication