COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04345523

Cristina Avendaño Solá, MD, PhD

cavendano@salud.madrid.org

2020-04-14

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: written informed consent prior to performing study procedures. witnessed oral consent will be accepted in order to avoid paper handling. written consent by patient or representatives will be obtained as soon as possible. male or female adult patient ≥18 years of age at time of enrolment. has laboratory-confirmed sars-cov-2 infection as determined by pcr in naso/oropharyngeal swabs or any other relevant specimen in the ongoing covid-19 symptomatic period. alternative test (i.e antigenic tests) are also acceptable as laboratory confirmation if their adequate specificity has been accepted by the sponsor. patients requiring hospitalization for covid-19 without mechanical ventilation (invasive or non-invasive) or high flow oxygen devices and at least one of the following: radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, ct scan, etc.), or clinical assessment (evidence of rales/crackles on exam) and spo2 ≤ 94% on room air that requires supplemental oxygen. no more than 7 days between the onset of symptoms (fever or cough) and treatment administration day.

requiring mechanical ventilation (invasive or non-invasive) or high flow oxygen devices. more than 7 days since symptoms (fever or cough). participation in any other clinical trial of an experimental treatment for covid-19. in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. any incompatibility or allergy to the administration of human plasma. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr <30).

2

Cristina Avendaño Solá

18

None

Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

350

Category Changes in the "7-Ordinal Scale"

None

Phase 2

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