NCT04356482.

Study name	Determination of the dose and effectiveness of convalescent plasma in severely and very severely ill patients by COVID‐19
Methods	Trial design: interventional, single‐arm Sample size: 90  Setting: critically ill patients  Country: Mexico Language: English Number of centres: 4
Participants	Inclusion criteria All patients with COVID‐19 test positive  Severely ill patient respiratory difficulty sat O2 < 93% without O2 but improves with the use of supplemental oxygen CT scan image: COVID‐19‐compatible pneumonia ≥ 1 of at least: SOFA = 0, D‐dimer ≥ 500, age ≥ 65 years, comorbidities such as high blood pressure, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, ≥ 1 degree of obesity Very severely ill respiratory difficulty that does not improve with supplemental oxygen, requiring intubation and connecting to ventilatory support of no > 72 h or 3 days CT image: COVID‐19 compatible pneumonia ≥ 1 of at least: SOFA ≥ 1, D‐Dimer ≥ 750, age ≥ 65 years, comorbidities such as hypertension, diabetes mellitus type I and II, chronic kidney failure, controlled or cured cancer, ≥ 1 degree of obesity survival over 5 days Pregnant women are accepted Exclusion criteria Patients with asymptomatic/mild disease for COVID‐19 Children < 16 years old Patients with atypical pneumonia without COVID‐19 diagnostic for PCR‐RT
Interventions	CP therapy or hyperimmune globulin therapy: CP therapy Details of CP: type of plasma: CP, details not provided volume: different amounts to be given to severe vs very severe ill patients, not specified number of doses: NR 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): none Concomitant therapy: NR Treatment cross‐overs: none
Outcomes	Primary study outcome: clinical improvement, improvement in tomographic image, test positivity for COVID‐19, early and late complications 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: yes (up to 22 days) 30‐day and 90‐day mortality: NR Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: NR QoL: NR Additional outcomes Improvement in tomographic image (time frame: day ‐1 to day +12) Test positivity for COVID‐19 (time frame: day +6 to day +12)
Starting date	May 2020
Contact information	Luis M Villela, MD; +526624756529; luisvillela@yahoo.com Diego Espinoza, MD; +526623862375; dr.espinoza.peralta@gmail.com
Notes	Recruitment status: not yet recruiting Prospective completion date: December 2020 Sponsor/funding: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado