Created at Source Raw Value Validated value
Feb. 11, 2022, 8 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Eligible patients who provide written informed consent may be randomized to receive 250 mL (+10%) plasma (from an immunized donor) with an IgG titer of 1:1000 or greater hyperimmune plasma (experimental group; 180 participants) or control group (conventional treatment; called \u201csupportive\u201d) without experimental treatment; with an estimated 180 participants. The allocation of participants into two groups; control (no treatment; called \u201csupport\u201d) and experimental (recipients of plasma from immunized individuals); will be done randomly; by random-permuted block randomization; with blocks of 2 and 4 individuals stratified. by recruitment municipality and by vaccination status using the REDCap (Research Electronic Data Capture) system. The plasma bag containing the therapeutic dose will be defined as \u201chigh titer\u201d (hyperimmune) following the recommendations of the US regulatory agency FDA. The transfusion will start within 6 hours of recruitment and randomization and will be administered over a period of 1.5 to 2 hours. Patients will be monitored for adverse events for a minimum of 30 minutes after the intervention. The intervention consists of the administration of hyperimmune plasma within the first 72 hours of the onset of symptoms of SARS-CoV-2 infection followed by conventional treatment. The control group will receive only conventional treatment (no experimental treatment) for COVID-19. Patients should notify researchers if they are hospitalized. All patients will be contacted to record primary (hospitalization) and secondary outcomes (days free of ventilatory support; admission to intensive care units; use of mechanical ventilation; death; antibody titration; clinical worsening for severe respiratory distress syndrome; predominance of SARS-COV-2 variants); on days 10 an;E02.095.465.425", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]