COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04547127

Mireia Torres

mireia.torres@grifols.com

2020-09-14

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: hospitalized male or female subjects of ≥ 18 years of age at time of screening who are being treated in the intensive care unit (icu) for covid-19 for not longer than 48 hours or for whom a decision has been made that covid-19 disease severity warrants icu admission. subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (icf) prior to initiation of any study procedures. has laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase [rt]-pcr), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization. illness (symptoms) of any duration, and the following: radiographic infiltrates by imaging (chest x-ray, computerized tomography [ct] scan, etc.), and requiring mechanical ventilation and/or supplemental oxygen subjects with no limitation of therapeutic effort (decision on the status and future of the subject). female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit.

- clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. - the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue. - a medical condition in which the infusion of additional fluid is contraindicated. - shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed.

2

Instituto Grifols, S.A.

18

100

Spain

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

200

All-Cause Mortality Rate

None

Phase 2

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