NCT04376034.

Study name	Convalescent plasma collection from individuals that recovered from COVID19 and treatment of critically ill individuals with donor convalescent plasma
Methods	Trial design: prospective, non‐randomized, sequential‐assigned, clinical trial Sample size: 240 Setting: inpatient Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria: Individuals of any age > 30 days of life, sex, or pregnancy status suffering from confirmed COVID‐19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines. Must have laboratory‐confirmed COVID‐19 Must have severe or immediately life‐threatening COVID‐19 Must provide informed consent/assent Exclusion criteria: Individuals with COVID‐19 who are not in clinical concern for rapid progression, severe or critical condition Individuals who are in critical condition that are not confirmed to have COVID‐19 Individuals with known selective IgA deficiency, that has not been found to be absent of anti‐IgA antibodies Donor eligibility criteria: Prior diagnosis of COVID‐19 documented by a laboratory test Abbott RealTime SARS‐CoV‐2 real‐time RT‐PCR test on the Abbott m2000 System (inpatient WVU testing) Other testing methods and vendors using FDA‐approved detection methods of SARS‐CoV‐2 under the Emergency Use Authorization (EUA) Complete resolution of symptoms at least 28 days prior to donation Complete resolution of symptoms for at least 14 days with negative repeat COVID‐19 testing approved by the FDA EUA Female donors age 18+ that have never been pregnant or negative for HLA antibodies Male donors age 18+ Negative results for COVID‐19 either from ≥ 1 nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at www.fda.gov/medical‐devices/emergency‐situations‐medical‐devices/emergency‐use‐authorizations. Defined SARS‐CoV‐2 neutralising antibody titres, if testing can be conducted (e.g. of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable) ≥ 50 kg of weight Donor exclusion criteria: Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent Individuals' plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
Interventions	Intervention(s): CP  Details of CP for moderate severity: 1 unit Type of plasma: plasma obtained from volunteers who have recovered from SARS‐Cov‐2 infection Volume: 200‐250 mL (adult recipient), 10 mL/kg up to 1 unit of plasma (pediatric recipient) Number of doses: 2 infusions be administered with 24‐72 h in between Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Details of CP for severe or critical severity:  2 units Type of plasma: plasma obtained from volunteers who have recovered from SARS‐Cov‐2 infection Volume: 200‐250 mL (adult recipient), 10 mL/kg up to 1 unit of plasma (pediatric recipient) Number of doses: 2 infusions be administered with 24‐72 h in between Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator for mild severity: standard of care Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: Plasma donor (time frame: measured in days for 365 days), time it takes to identify eligible donors who are willing to donate Plasma donor (time frame: measured in days for 365 days), time it takes the plasma collection center to contact willing donors who are allowed to donate plasma Plasma recipient (time frame: measured every 24 h up to 30 days), time from consent to infusion Plasma recipient (time frame: measured in days with 30 day from discharge follow‐up), survival Primary review outcomes reported All‐cause mortality at hospital discharge: yes, 30‐day mortality Time to death: NR Secondary review outcomes reported Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): yes  Number of participants with SAEs: yes  Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes 30‐day and 90‐day mortality: yes (30‐day mortality) Admission on the ICU: yes Length of stay on the ICU: yes   Time to discharge from hospital: yes  QoL: NR Additional study outcomes Plasma recipient (time frame: Day 1, 2, 3, 4, 7, and 30 day) morbidity reduction Plasma donor (time frame: measured every 24 h up to 1 year) time until plasma is donated
Starting date	16 April 2020
Contact information	Brian Peppers, DO, PhD 304‐594‐2483 brian.peppers@hsc.wvu.edu Lisa Giblin Sutton, Pharm D 304‐293‐0928 giblinl@wvumedicine.org
Notes	Recruitment status: not yet recruiting Prospective completion date: 30 March 2021 Sponsor/funding: West Virginia University