COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04391101

Oliver G Perilla Suarez, Hematologist

gerardoperilla@gmail.com

2020-05-18

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: for plasma donors: - over 18 years of age - men or nulliparous women with no history of recent abortions or transfusions sars-cov-2 infection by pcr in any sample or serological test with a maximum of 60 days from resolution of symptoms. - if donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative pcr test for sars-cov-2. if donation is done after 28 days of resolving symptoms, no negative control test will be required. for plasma recipients: - over 18 years of age - sars-cov-2 infection confirmed by pcr in any sample - hospitalized in the icu due to shock or respiratory failure, with less than 24 hours after entering the icu.

for plasma donors: - severe sars-cov-2 infections with an icu requirement or those with asymptomatic infections will not be accepted as donors. - nor will a person who has received convalescent plasma as part of the covid-19 treatment. for plasma receivers: - serious volume overload or other condition that contraindicates plasma transfusion. - history of anaphylaxis or serious adverse reaction to plasma. - previous diagnosis of immunoglobulin a deficiency

2

Hospital San Vicente Fundación

18

None

Colombia

Severe disease at enrollment

6: Severe disease at enrollment

231

Intrahospital mortality from any cause

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"}]