NCT04388410.

Study name	Phase 2b/3 trial to evaluate the safety and efficacy of plasma transfusion from convalescent patients with SARS‐CoV‐2 infection on severity and mortality of COVID‐19 in hospitalized patients.
Methods	Trial design: RCT, double‐blinded, multicentre, placebo‐controlled Sample size: 250 Setting: inpatient Country: Mexico Language: English Number of centres: at least 6
Participants	Inclusion criteria Adults ≥ 18 years Confirmed SARS‐CoV2 infection Hospitalised for COVID‐19 Severe disease or risk for severe disease Informed consent from patient or responsible person Exclusion criteria History of allergic reactions to blood products SOFA scale > 12 points Absolute contraindication for administration of plasma Participation in other blinded clinical trial Projected life expectancy < 3 months Any condition perceived by the investigator as not appropriate for participation of the patient in the trial
Interventions	Intervention(s): normal saline and CP therapy Details of CP: Type of plasma: NR Volume: 200 mL Number of doses: 2 separated by 24‐72 h  Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): hospitalised patients Comparator: normal saline  Concomitant therapy: NR Treatment cross‐overs: no
Outcomes	Primary study outcome: Severity and death (time frame: 28 days) AEs that require study treatment interruption (time frame: 28 days) Primary review outcomes reported All‐cause mortality at hospital discharge: mortality (time frame: 28 days) Time to death: yes (time frame: 28 days) 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 by ordinal 8‐point severity outcome scale (time frame: Days 1, 3, 5, 7, 12, 14, 21, 28) 30‐day and 90‐day mortality: yes (28‐day mortality) Admission on the ICU: yes Length of stay on the ICU: yes (ICU hospitalisation) Time to discharge from hospital: yes (hospitalisation time) QoL: NR Additional study outcomes Antibodies against SARS‐CoV‐2 (time frame: Days 0, 3, 7, 14, 21, 28) Time on mechanical ventilation (time frame: 28 days) Number of days with fever (time frame: 28 days)
Starting date	1 June 2020
Contact information	Not provided
Notes	Recruitment status: Not yet recruiting Prospective completion date: December 31, 2020 Sponsor/funding: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran