COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04547660

Leo Sekine, PhD

lsekine@hcpa.edu.br

2020-09-14

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age equal to or greater than 18 yers; diagnosis of sars-cov-2 infection through nasal cavity or oropharynx swab rt-pcr; severe covid-19 defined by the presence of at least 1 of the following: a. respiratory rate> 30 breaths per minute in room air; b. oxygen saturation (o2) ≤93% in room air; c. pao2 / fio2 ratio ≤300; d. need for supplemental o2 to maintain o2 saturation> 95%; e. need for therapy with supplemental o2 by high flow catheter or non-invasive ventilation or invasive mechanical ventilation; onset of symptoms in a period not exceeding 14 days.

impossibility for any reason to perform the first plasma infusion within 14 days of the onset of symptoms; use of immunosuppressants for other underlying diseases, except corticosteroids for the sars-cov-2, in the last 30 days before enrollment; pregnancy; history of serious adverse reactions such as transfusion anaphylaxis; participation in another interventional clinical trial; disagreement of attending physician; disagreement of the patient or legal representative to participate in the study.

2

Hospital de Clinicas de Porto Alegre

18

100

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

160

Clinical improvement

None

Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]