Table 1.
RCT identifier | Country | Recruitment (out of expected) (randomization strategy) | Control arm components | Median days from symptoms or hospital admission | Baseline recipient WHO score* | Median nAb in CCP units | Median nAb in recipient | Transfused CCP volume (ml) | Outcome | Refs |
---|---|---|---|---|---|---|---|---|---|---|
ChiCTR2000029757 | China | 103 (out of 200) (1:1) | BSC | 30 (from symptoms) | 5–6 | not assessed | not assessed | 200 | Reduced mortality at day 28 only in WHO score 5 patients (HR 2·5) | [21] |
NCT04342182 (ConCOVID) | Netherlands | 86 (out of 426) (1:1) | BSC | 10 (from symptoms) | 5–6 | 1:160 | 1:160 in 79% of recipients | 300 | No benefit at day 15 | [14] |
CTRI/2020/04/024775 (PLACID) | India | 464 (1:1) | BSC | 6 (from symptoms) | 4–5 | 1:40 | 1:90 | 200 + 200 | No benefit at day 28 | [13] |
NCT04345523 (ConPlas‐19) | Spain | 81 (out of 278, still recruiting) (1:1) | BSC | 8 (from symptoms) |
3 (25%) 4 (75%) |
1:292 | not assessed | 250–300 | Reduced mechanical ventilation or death (0% vs. 14%). Mortality rates were 0% vs. 9·3% at days 15 and 29 for the active and control groups, respectively. | [12] |
NCT04375098 | Chile | 58 (1:1) | late CCP | 6 (from symptoms) | 3‐4 | ≥1:160 | 59% <1:160 (16% of patients enrolled before day 5 were ≥1:160 vs. 60% of those enrolled after day 6 | 200 + 200 | NO benefit at day 30 in death, mechanical ventilation or prolonged hospitalization compared to CCP administration only in case of clinical worsening or >7 days after enrolment | [22] |
NCT04479163 | Argentina | 160 (out of 210) (1:1) | normal saline | ≤3 (from symptoms; and > 65 yrs) | 3 | Not assessed | Not assessed | 250 | Progression to severe COVID‐19 halved at day 30 | [10] |
NCT04383535 (PlasmAr) | Argentina | 333 (2:1) | normal saline | 8 (from symptoms) | 5 | 1:300 IC80 | Not assessed | 500 | No benefit at day 30 (16·2% vs. 31·2%) | [9] |
CTRI/2020/05/025209 | India | 80 (1:1) | BSC | 4·2 (from hospital admission) | 5 | Not assessed | Not assessed | 200 + 200 | Immediate mitigation of hypoxia, reduction in hospital stay as well as survival benefit was recorded in severe COVID‐19 patients with ARDS aged less than 67 years | [11] |
NCT04356534 | Bahrain | 40 (1:1) | BSC | n.a. |
4 (95%) 5 (5%) |
Not assessed | Not assessed | 200 + 200 | No difference in requirement for ventilation, white blood cell count, LDH, CRP, troponin, ferritin, D‐dimer, procalcitonin, mortality rate at 28 days | [23] |
NCT04346446 | India | 29 (1:1) | FFP | <3 (from symptoms) | 4‐5 | not assessed | not assessed | 250 + 250 | Better median improvement in PaO2/FiO2 at 48‐h [42 vs. 231] and at day 7 | [24] |
BKH‐CT‐012 | Iraq | 49 (1:1) | BSC | <3 (from ICU admission) | 5 | not assessed | not assessed | 400 | Duration of infection reduced by 4 days; mortality 1/21 in CCP arm vs. 8/28 | [25] |
RCT, randomized controlled trial; WHO, World Health Organization; nAb, neutralizing antibodies; CCP, COVID‐19 convalescent plasma; Ref, reference; BSC, best supportive care; FFP, fresh‐frozen plasma; n.a., not assessed; HR, hazard ratio; ARDS, acute respiratory distress syndrome; LDH, lactate dehydrogenase; CRP, C‐reactive protein; PaO2/FiO2, partial pressure of arterial oxygen to fraction of inspired oxygen ratio; ICU, intensive care unit. ‘Not assessed’ means that antivirus antibodies were assessed only using high‐throughput serology. | ||||||||||
*The WHO score [20] ranges from 0 to 8: 0: no clinical or virological evidence of infection; 1: no limitations of activities; 2: limitations of activities; 3: hospitalized, no oxygen therapy; 4: oxygen by mask or nasal prongs; 5: non‐invasive ventilation or high‐flow oxygen; 6: intubation and mechanical ventilation; 7: ventilation + additional organ support ‐ pressors, renal replacement therapy, extracorporeal membrane oxygenation; and 8: death. | ||||||||||
Here below, an alternative layout/adaptation of Table 1. |
RCT identifier [Country] | Recruited (out of expected) [randomization strategy] | Control arm components | Median days from symptoms or hospital admission | Baseline recipient WHO score* | Median nAb in CCP units | Median nAb in recipient | Volume of CCP transfused (ml) | Outcome | Refs |
---|---|---|---|---|---|---|---|---|---|
ChiCTR2000029757 [China] | 103 (of 200) [1:1] | BSC | 30 (from symptoms) | 5–6 | n.a. | n.a. | 200 | Reduced mortality at day 28 only in WHO score 5 patients (HR 2·5) | [21] |
NCT04342182 (ConCOVID) [Netherlands] | 86 (of 426) [1:1] | BSC | 10 (from symptoms) | 5–6 | 1:160 | 1:160 in 79% of recipients | 300 | No benefit at day 15 | [14] |
CTRI/2020/04/024775 (PLACID) [India] |
464 [1:1] | BSC | 6 (from symptoms) | 4–5 | 1:40 | 1:90 | 200 + 200 | No benefit at day 28 | [13] |
NCT04345523 (ConPlas‐19) [Spain] | 81 (of 278, still recruiting) [1:1] | BSC | 8 (from symptoms) |
3 (25%) 4 (75%) |
1:292 | n.a. | 250–300 | Reduced mechanical ventilation or death (0% vs. 14%). Mortality rates were 0% vs. 9·3% at days 15 and 29 for the active and control groups, respectively. | [12] |
NCT04375098 [Chile] | 58 [1:1] | late CCP | 6 (from symptoms) | 3–4 | ≥1:160 | 59% <1:160 (16% of patients enrolled before day 5 had ≥1:160 vs. 60% of those enrolled after day 6 | 200 + 200 | No benefit at day 30 in death, mechanical ventilation or prolonged hospitalization compared to CCP administration only in case of clinical worsening or >7 days after enrolment | [22] |
NCT04479163 [Argentina] | 160 (of 210) [1:1] | Normal saline | ≤ 3 (from symptoms; and >65 years) | 3 | n.a. | n.a. | 250 | Progression to severe COVID‐19 was halved at day 30 | [10] |
NCT04383535 (PlasmAr) [Argentina] | 333 [2:1] | normal saline | 8 (from symptoms) | 5 | 1:300 IC80 | n.a. | 500 | No benefit at day 30 (16·2% vs. 31·2%) | [9] |
CTRI/2020/05/025209 [India] | 80 [1:1] | BSC | 4·2 (from hospital admission) | 5 | n.a. | n.a. | 200 + 200 | Immediate mitigation of hypoxia, reduction in hospital stay as well as survival benefit in severe COVID‐19 patients with ARDS aged < 67 years | [11] |
NCT04356534 [Bahrain] | 40 [1:1] | BSC | n.a. |
4 (95%) 5 (5%) |
n.a. | n.a. | 200 + 200 | No difference in requirement for ventilation, white blood cell count, LDH, CRP, troponin, ferritin and D‐dimer, procalcitonin, mortality rate at 28 days | [23] |
NCT04346446 [India] | 29 [1:1] | FFP | <3 (from symptoms) | 4–5 | n.a. | n.a. | 250 + 250 | Better median improvement in PaO2/FiO2 at 48 h (42 vs. 231) and at day 7 | [24] |
BKH‐CT‐012 [Iraq] | 49 [1:1] | BSC | <3 (from ICU admission) | 5 | n.a. | n.a. | 400 | Duration of infection reduced by 4 days; mortality 1/21 in CCP arm vs. 8/28 | [25] |