NCT04333355.

Study name	Phase 1 study to evaluate the safety of convalescent plasma as an adjuvant therapy in patients with SARS‐CoV‐2 infection
Methods	Trial design: single‐arm, phase I, intervention study Sample size: 20 Setting: hospital Country: Mexico Language: English Number of centres: 1
Participants	Inclusion criteria Patients ≥ 18 years Confirmed SARS‐CoV‐2 infection by RT‐PCR Serious or life‐threatening infection defined as: serious: dyspnoea; respiratory rate ≥ 30 cycles/min; blood oxygen saturation ≤ 93% with an oxygen supply > 60%; PaO2/FiO2 < 300; 50% increase in pulmonary infiltrates defined by CT scans in 24‐48 h life‐threatening infection: respiratory failure; septic shock; dysfunction or multiple organ failure Refractory to treatment with azithromycin/hydroxychloroquine or chloroquine/ritonavir/lopinavir defined as: 48 h with no improvement in the modified parameters such as serious or clinically imminent infection Signed informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents) Exclusion criteria Patients with a history of allergic reaction to any type of previous transfusion Heart failure patients at risk of volume overload Patients with a history of chronic kidney failure in the dialysis phase Patients with previous haematological diseases (anaemia < 10 g of haemoglobin, platelets > 100,000/µL) Any case where the study author decides that the patient is not suitable for the protocol
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP therapy Details of CP: type of plasma: apheresis plasma volume: 500 mL total number of doses: 2 antibody‐titre: NR pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): not applicable Concomitant therapy: supportive standard care Treatment cross‐overs: not applicable
Outcomes	Primary study outcomes: possible adverse effects (time frame: 14 days) Primary review outcomes All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes 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: NR 30‐day and 90‐day mortality: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes Heart failure Pulmonary oedema Lung infiltrates by thorax CT Viral load of SARS‐CoV‐2 by RT‐PCR
Starting date	15 April 2020
Contact information	Servando Cardona‐Huerta, MD., Ph.D; +5218112121946; servandocardona@tec.mx           Sylvia De la Rosa, MD; +5218111832730; sylvia.delarosa@tec.mx
Notes	Recruitment status: not yet recruiting Prospective completion date: 30 April 2021  Sponsor/funding: Hospital San Jose Tec de MonterreyTecnologico de Monterrey