Table 2.
Characteristics of ongoing clinical and preclinical trials of convalescent/hyperimmune plasma treatment against COVID-19 (updated on November 05, 2020).
| Trial no. | Country | Objective | Design | Phase(s) | Last update | Indication | Age Eligible for Study | Study population | Schedule | Donor titer |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT04377672 [35] | USA | Safety of CP* administration; prevent or lessen disease severity | Interventional (clinical trial) | Phase 1 | June 2, 2020 | High risk of developing COVID-19 due to recent exposure | 1 mth - 18 yrs | 30 | 1−2 unit (200−250 mL per unit) of CP* | >1:320 |
| NCT04377568 [37] | Canada | CP* for hospitalized children | Multicenter, open-label, randomized controlled trial | Phase 2 | October 8, 2020 | Hospitalized with COVID-19 illness | < 18 yrs | 100 | One infusion of CP* 10 mL/kg, up to a maximum of 500 m L | – |
| NCT04462848 [36] | USA | Safety and pharmacokinetics | Interventional (clinical trial); single group assignment) | Phase 1 | July 8, 2020 | Cardiovascular disease, lung disease, immunosuppression | 1 mth - 17 yrs | 30 | CP* 5 mL/kg. Maximum volume 500 m L | |
| NCT04352751 [34] | Pakistan | Real-life setting clinical data in local population; evidence-based management of disease condition | Interventional (clinical trial) | Not Applicable | September 29, 2020 | Severe or critical illness | 18−55 yrs (adults) | 2000 | Children: CP* 15 ml/kg if <35 kg body weight. Adults: CP* max 450 - 500 ml once in all adults. |
NA |
| NCT04360486 [25] | USA | Treatment option for patients with severe COVID-19 infection | Expanded access open-label, single-arm, multi-site protocol | – | April 27, 2020 | Severe or life-threatening | Child, adult, older adult | – | – | – |
| NCT04374370 [26] | USA | Expanded access to CP* | – | – | May 5, 2020 | Severe Acute Respiratory Syndrome | 6−99 yrs | – | – | – |
| NCT04458363 [27] | USA | Safety of CP* for children | Interventional (clinical trial); randomized | Early Phase 1 | July 7, 2020 | Severe COVID-19 disease | <22 Yrs (child, adult) | 50 | 10 mL/kg/dose (up to 2 units per dose); two doses per patient for a total dose of 20 mL/kg | – |
| NCT04528368 [28] | Brazil | Efficacy and safety of CP* | Interventional (clinical trial) | Phase 2 | August 27, 2020 | No indication of ventilatory support | Child, adult, older adult | 60 | 400 mL of CP* | ≥ 1: 320 |
| NCT04361253 [29] | USA | Early addition of CP* to standard treatment improves clinical outcome | Prospective randomized, double-masked, placebo-controlled trial | Phase 3 | May 18, 2020 | Active COVID-19 infection in hospitalized patients | Age >1 yr | 220 | 250 mL, max500 mL | – |
| NCT04376034 [30] | USA | Help fight infection in patients with COVID-19 | Interventional (clinical trial), non-randomized, prospective | Phase 3 | May 6, 2020 | Mild, moderate and severe/critical severity | 31 dys and older | 240 | 10 mg/kg up to 2 units of CP* | |
| NCT04381936 [31] | UK | Prevention of death in patients with COVID-19 | Randomized trial | Phase 3 | September 29, 2020 | Patients with COVID-19 in hospital care | Child, adult, older adult | 15,000 | 275 ml ± 75 ml per day on study days 1 and 2 (minimum 12-h interval) | |
| NCT04349410 [32] | USA | Fleming method for tissue and vascular differentiation and metabolism | Randomized trial | Phase 3 | October 29, 2020 | Patients with COVID-19 | Child, adult, older adult | 1800 | CP* 2-units infused over 4-h | 1:320 |
| ISRCTN50189673 [33] | UK | To compare several different treatments potentially useful for patients with COVID-19 | Interventional, randomized adaptive trial | Recruiting | October 06, 2020 | COVID-19 (clinically suspected or laboratory-confirmed), and in hospital | Child, adult | – | – | – |
Legend: * CP denotes convalescent plasma.