COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=016-20

Patricia Garcia

patricia.garcia@upch.pe

2020-06-27

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

&#1048576, 18 years old or older &#1048576, Hospitalized patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation. &#1048576, Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria: • Respiratory frequency >22 • O2 saturation &#8804,93% • PaO2 <60mmHg, PaCO2 >50mmHg o • PaO2/FiO2 <300 Or Critical disease with one or more o the following criteria: • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours • Shock &#1048576, Inform consent signed by patient or direct family member

&#1048576, Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components &#1048576, Multiorgan failure, defined by a SOFA score of >5 &#1048576, Hemodinamically unstable, with PA<60 mmH, refractory to the use of vasopressors &#1048576, Uncontroled concomitant infection &#1048576, Disseminated intravascular coagulation &#1048576, Miocardial infarction &#1048576, Acute coronary disease &#1048576, Patient on dialysis &#1048576, Intracranieal bleeding active within last 7 days.

2

UNIVERSIDAD PERUANA CAYETANO HEREDIA;

18

100

Peru

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

98

Outcome name:rate of development of serious adverse eventsMeasure:Serious adverse events related to transfusion of convalescent plasmaTimepoints:6 months

Phase 2

[{"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"}]