NCT04384588.

Study name	COVID19‐convalescent plasma for treating patients with active symptomatic COVID 19 infection (FALP‐COVID) (FALP‐COVID)
Methods	Trial design: multicentre, single‐arm, open‐label, non‐randomised clinical trial Sample size: 100  Setting: inpatient Country: Chile Language:  English Number of centres: 4
Participants	Inclusion criteria for all patients: Patient must sign an informed consent to participate in this trial Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID‐19 related Patients with severity criteria must have any of the following: dyspnoea and or respiratory rate ≥ 30/min and or saturation ≤ 93% with fraction of inspired oxygen 21% and/or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaFi) < 300 and/or lung images showing worsening in 24‐48 h Patients without severity criteria but with ≥ 2 risk factors: ≥ 50 years Any of the following comorbidities: diabetes mellitus, hypertension, COPD, chronic kidney failure, non‐oncological‐related chronic immunosuppression Total bilirubin > 1.2 mg/dL or blood urea nitrogen > 20 mg/dL or lactate dehydrogenase > 245 U/L D‐dimer > 1 mg/L Neutrophils ≥ 7.3 x 10³ and/or lymphocytes < 0,8 x 10³ µl CRP > 9.5 mg/dL and ferritin > 300 ug/mL Interleukin‐6 > 7 pg/mL Antineoplastic treatment such as radiotherapy‐ cytotoxic chemotherapy‐ immunotherapy‐ molecular therapy‐ oncological surgery during the last 8 weeks Exclusion criteria: known allergy to plasma Severe multiple organic failure Active intra brain haemorrhage Disseminated intravascular coagulation with blood products requirements Patient with an adult respiratory distress > 10 days patients with active cancer and life expectancy < 12 months according with medical criteria
Interventions	Intervention(s): CP Details of CP: Type of plasma: NR Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: NA Concomitant therapy: NR Treatment cross‐overs: NA
Outcomes	Primary study outcome: in hospital mortality Primary review outcomes reported All‐cause mortality at hospital discharge: yes 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): NR Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: days on ventilatory support 30‐day and 90‐day mortality: yes  Admission on the ICU: yes Length of stay on the ICU: yes  Time to discharge from hospital: yes  QoL: NR Additional study outcomes viral load, laboratory studies
Starting date	7 April 2020
Contact information	Contact: Christian Caglevic, MD56981369487 christian.caglevic@falp.org
Notes	Recruitment status: recruiting Prospective completion date: 6 April 20201 Sponsor/funding: Fundacion Arturo Lopez PerezConfederación de la Producción y del Comercio (CPC)Bolsa de Santiago