NCT04542967.

Study name	Convalescent plasma as a treatment for patients with severe COVID‐19 disease
Methods	Trial design: Randomised, double‐blind controlled trial Sample size: 150 Setting: inpatient Country: Mexico Language: English Number of centres: 1
Participants	Inclusion criteria O2 saturation <93% Radiographic evidence of moderate pneumonia according to Rale's classification. Acute respiratory distress syndrome (PaO2/FiO2 < 300 or SpO2/FiO2 ≤ 315) Authorisation to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated) Exclusion criteria Pregnant patients History of transfusion reactions Patients with congestive heart failure Patients with a history of chronic kidney failure on dialysis Patients with multiple organ failure Patients who does not accept or agree with the treatment.
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR volume: 200 mL number of doses: 2 doses antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out For studies including a control group: comparator (type): standard of care Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome:  Disease progression [ Time Frame: Up to 30 days later from study entry ] = Change in ordinal Scale for Clinical Improvement (WHO). The progression of disease, its change in the severity score; a bigger number to the obtained after randomization Side effects [ Time Frame: Up to 30 days later from study entry ] = Side effects associated with the administration of convalescent plasma Mortality [ Time Frame: Up to 30 days later from study entry ] = any cause of death Primary review outcomes All‐cause mortality at hospital discharge: NR 30‐day mortality: reported Secondary review outcomes Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale,  WHO Ordinal Scale for Clinical Improvement at up to 7 days, 8 to 15 days, 16 to 30 days: partially (see primary study outcomes) Mortality (time to event): NR 90‐day mortality: NR Time to discharge from hospital: NR Admission to the intensive care unit (ICU): NR Length of stay on the ICU: NR Viral clearance, assessed with RT‐PCR test at baseline, up to 3, 7, and 15 days: NR QoL: NR Number of participants with grade 3 and grade 4 adverse events, including potential relationship between intervention and adverse reaction (e.g. transfusion‐related acute lung injury (TRALI), transfusion‐transmitted infection, transfusion‐associated circulatory overload (TACO), transfusion‐associated dyspnoea (TAD), acute transfusion reactions): NR Number of participants with serious adverse events: NR Additional study outcomes Respiratory improvement [ Time Frame: 10 days ] Clinical improvement [ Time Frame: 10 days ] Acute adverse events (AAE) [ Time Frame: After receiving intervention, an average time one hour, until 24 hours after administration. ] = Transfusion reactions during transfusion. Inflammatory biomarkers (D dimer) [ Time Frame: 10 days ] Inflammatory biomarkers (Ferritin) [ Time Frame: 10 days ] Inflammatory biomarkers (CPR) [ Time Frame: 10 days ] Inflammatory biomarkers (LDH) [ Time Frame: 10 days ]
Starting date	23 June 2020
Contact information	Contact: Carmen G Torres, MD: dragabytorresalarcon@icloud.com
Notes	Recruitment status: recruiting Prospective completion date: September 30, 2020 Sponsor/funding: Hospital Central Militar