COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=060-20

Mario Ortiz

ortiz60marina51@hotmail.com

2020-09-21

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

• Patients over 18 years of age from both sexes hospitalized at the Centro Medico Naval. • Be in the disposition and capacity to give free and informed consent, or have a relative or tutor with the capacity to do so (Appendix 2) • Be in the disposition and capacity to undergo clinical evaluations and diagnosis procedures. • Previous COVID-19 diagnosis supported by a laboratory test (PCR-RT or by the presence of SARS-CoV-2 antibodies). • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria during a span of less than 10 days. • Need of mechanical ventilation or continuous oxygenation at positive pressure.

• Diagnosis of Mild Acute Respiratory Distress Syndrome according to the definition of the Berlin criteria. • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria, lasting more than 10 days. • Demonstrated hypersensitivity or history of allergy to blood products or immunoglobulins. • Pregnant or breastfeeding women

2

Marina de Guerra del Peru;

18

100

Peru

Critical disease at enrollment

8: Critical disease at enrollment

100

Outcome name:It is defined as an event of death due to the 2019 Coronavirus disease or another cause that occurred between the start of treatment until day 60.Measure:MortalityTimepoints:60 days from the first day of treatment.

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"}]