COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-3fz9yr

Paulo Brofman

paulo.brofman@pucpr.br

2020-08-31

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

COVID-19 patients, that require intensive care surveillance and ventilatory support, PaO2/FiO2 less than or equal to 200 (Berlin criteria of moderate-to-severe acute respiratory)

Previous or current history of malignancy under treatment, pre-existing thromboembolic disease, concomitant HIV or tuberculosis infection, pre-existing transplant or use immunosuppressive therapy and pregnancy

2

Paulo Roberto Slud Brofman

18

100

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Safety through the assessment of adverse events.Security will be assessed by recording all adverse events; according to the Common Terminology Criteria for Adverse Events version 5.0; based on duration; intensity and possible association with the treatment under study. In particular; the absolute number of unexpected and suspected severe adverse events and serious adverse events recorded during the follow-up study that should not exceed 10%; will be taken into account.

Not reported

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]