COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04497324

Fiorella Krapp Lopez, MD, MSc

fiorella.krapp@upch.pe

2020-08-04

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - hospitalized 18 years old or older patient with covid-19 disease, confirmed by a molecular test or a serologic test, along with a typical covid-19 clinical presentation. - 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 ≤93% - pao2 50mmhg - pao2/fio2 <300 - or critical disease with one or more of the following criteria: - respiratory insufficiency with requirement of mechanical ventilation within the last 72hours - shock - inform consent signed by patient or direct family member.

- contraindication for transfusion (history of trali or taco, history of anaphylaxis to blood components - multiorgan failure, defined by a sofa score of >5 - hemodynamically unstable, with mean arterial pressure <60 mmhg, refractory to vasopressors use - uncontrolled concomitant infection - disseminated intravascular coagulation - myocardial infarction - acute coronary disease - patient on dialysis - intracranial bleeding active within the last 7 days - pregnancy

2

Universidad Peruana Cayetano Heredia

18

100

Peru

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

100

Transfusion-related Serious Adverse Events

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]