Table 1. Study design, arms, interventions, and study time progress.
Identity number |
Phase | Patient features |
Intervention by arm | CP dose (day) | Age range (years) |
Start date |
Completion date |
Progress (%) |
Recruitment status |
---|---|---|---|---|---|---|---|---|---|
NCT02735707(10) | IV | Severe acute respiratory illness and severe community acquired pneumonia | Corticosteroid versus antibiotics versus macrolide versus Influenza antiviral versus LPV/Rit versus HydChl versus IFN-β1a versus Anak versus Tmab versus Smab versus Vit C versus heparin versus simvastatin versus CP versus ST | 1 or 2 units within 48 hours | >18 | 4/11/16 | 12/1/23 | 58 | Recruitingz |
NCT04391101(11) | III | Severe patients treated in ICU | CP associated with ST versus ST | 400-500mL | >18 | 6/1/20 | 12/1/21 | 19.2 | Not yet recruiting |
NCT04372979(12) | III | Early care of hospitalized patients | CP associated with ST versus SP associated with ST | 200-230mL | 18-80 | 5/1/20 | 5/1/21 | 37.3 | Not yet recruiting |
NCT04418518(13) | III | Early care for patients hospitalized | CP associated with ST versus ST | 500mL of single-donor or 2 units of 250mL from 1-2 donations | 18-70 | 6/24/20 | 12/1/21 | 15.6 | Recruiting |
NCT04355767(14) | III | Severe/critical hospitalized patients | CP (antibodies titers ≥1:160) versus placebo | CP: 1-unit versus placebo: saline with multivitamin | >18 | 8/11/20 | 12/1/22 | 4.0 | Not yet recruiting |
NCT04432103(15) | III | Severe/critical hospitalized patients | CP from IgG (severe patients versus critical patients) associated with ST | NR | >19 | 6/19/20 | 9/30/20 | 84.5 | Not yet recruiting |
NCT04348656(16) | III | Early care for patients hospitalized | CP versus ST | 500mL of single-donor or 2 units of 250mL from 1-2 donations | >20 | 5/14/20 | 12/31/20 | 53.2 | Recruiting |
NCT04425915(17) | III | Severe/critical hospitalized patients | CP associated with ST versus ST | 2 doses of 250mL on consecutive day started by day 3 of symptom onset | >21 | 6/14/20 | 5/30/21 | 26.3 | Recruiting |
NCT04362176(18) | III | Patients hospitalized or in ICU | Pathogen reduced CP versus placebo | CP: 500mL within 12 hours (day 0) versus placebo: 250mL of Lactate Ringers associated with multivitamins (day 1) | >22 | 4/24/20 | 4/1/21 | 41.8 | Recruiting |
NCT04381858(19) | III | Severe respiratory failure with invasive mechanical ventilation | CP (antibodies titers >1:164) versus HIg | CP: 400mL (2 units) versus HIg: 0.3g/kg/day (5 doses) | 16-18 | 5/6/20 | 9/30/20 | 89.1 | Recruiting |
NCT04361253(20) | III | Patients hospitalized | CP (high-titer) versus SP (FFP or FP 24) | HT-CP: 2 doses of 250mL of single donor within 24 hours; FFP: 2 units of 200-275mL | >1 | 04/30/20 | 12/1/21 | 23.6 | Recruiting |
NCT04376034(21) | III | Mild, moderate and severe/critical severity | CP associated with ST versus ST | Adult: 200 to 250mL; children: 10mL/kg; 2 units severe patients or critical condition | >30 days | 4/16/20 | 3/30/21 | 43.4 | Recruiting |
NCT04483960(22) | III | No severe patients | LPV/Rit versus HydChl versus CP | 1 unit on day 1 and day 2 | >18 | 7/21/20 | 6/12/22 | 8.0 | Recruiting |
NCT0434528 9(23) | III | Mild, moderate and severe/critical hospitalized patients | CP associated with ST (Smab versus baricitinib versus HydChl) versus ST associated with injective placebo | CP: (twice 300mL) and single dose of 600mL; placebo: (twice 300mL) and single dose of 600mL IV saline oral placebo: three times/day (7 days) | >18 | 5/1/20 | 6/15/21 | 33.2 | Recruiting |
NCT04342182(24) | II-III | Hospitalized patients | CP associated with ST versus ST | 300mL (according to the Erasmus MC KIS protocol) | >18 | 4/8/20 | 7/1/20 | 100 | Recruiting |
NCT04388410(25) | II-III | Hospitalized patients with severe disease or at risk for severe disease. | CP versus placebo | CP: 2 units of 200mL within 24-72 hours); placebo: 200mL of saline | >18 | 8/25/20 | 12/31/20 | 15.6 | Not yet recruiting |
NCT04374526(26) | II-III | Hospitalized patients | CP associated with ST versus ST | 200mL/day for 3 days | >65 | 5/27/20 | 6/30/21 | 27.6 | Recruiting |
NCT04384588(27) | II-III | Oncological and non-oncological patients with severe disease | CP associated with ST versus ST | 1 or more units | >15 | 4/7/20 | 4/6/21 | 44.0 | Recruiting |
NCT04425837(28) | II-III | Hospitalized patients at high risk of severe disease or in ICU | CP (antibodies titers of ≥1:160) associated with ST versus ST | 2 doses of 200mL in a day | >18 | 7/1/20 | 2/1/21 | 34.9 | Not yet recruiting |
NCT04395170(29) | II-III | Early care for patients hospitalized | CP associated with ST versus anti-COVID-19 HIg versus ST | CP: 200-250mL (day 1 and 3); 10% IgG solution: 50mL (patient ≥50kg); 1 mL/Kg (patient <50Kg), on days 1 and 3 | >18 | 9/1/20 | 6/1/21 | 4.8 | Not yet recruiting |
NCT04380935(30) | II-III | Hospitalized patients in ICU (using mechanical ventilation) | CP associated with ST versus ST | NR | >18 | 5/18/20 | 10/31/20 | 71.7 | Not yet recruiting |
NCT04332835(31) | II-III | Moderate and severe/critical severity | CP associated with ST versus HyChl associated with ST | 250mL on days 1 and 2 | 18-60 | 8/8/20 | 10/31/20 | 44.0 | Not yet recruiting |
NCT04385043(32) | II-III | Severe/critical hospitalized patients | CP associated with ST versus ST | NR | 18-60 | 5/1/20 | 5/15/21 | 35.9 | Recruiting |
NCT04381936(33) | II-III | Hospitalized patients at high-risk of severe disease | LPV/Ritversus corticosteroid versus HyChl versus Azi versus Tmab associated with ST versus CP associated with ST | 275mL±75mL on days 1 and 2 | all | 3/19/20 | 12/1/31 | 4.2 | Recruiting |
Passive immunotherapy occurs through the infusion of plasma from convalescent individuals, hence the use of the term convalescent plasma which can also be called hyperimmune plasma or ABO-compatible convalescent plasma.
CP: convalescent plasma; LPV: lopinavir; Rit: ritonavir; HydChl: hydroxychloroquine; IFN-β1a: interferon-β1a; Anak: anakinra; Tmab: tocilizumab; Smab: sarilumab; Vit C: vitamin C; ST: standard therapy; ICU: intensive care unit; SP: standard plasma; IgG: immunoglobulin G; NR: not report; HIg: human immunoglobulin; FFP: fresh frozen plasma; FP24: plasma frozen within 24 hours after phlebotomy; HT-CP: high-titer convalescent plasma; IV: intravenous; Azi: azithromycin.