COVID-19 trials registries data warehouse

https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=013-20

AUSBERTO CHUNGA

Bettochunga17@hotmail.com

2020-06-25

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Hospitalized patients &#8805,18 años 2. Informed consent 3. Confirmed diagnosis of SARS-CoV2 infection via RT-PCR of nasopharingeal swabing 4. Patients at risk of progression defined as having two or more of the following: • Ferritin > 500 ng/mL • D-dimer > 1 mg/L • Reactive C-Protein > 15 mg/L • Total Lymphocytes < 1000/mm3 or Neutrophil/Lymphocyte ratio > 3.13 • Admission to a Intense care unit for management of COVID-19 or pacients with severe diasease defined as having two or more of the following: • Dispnea • Respiratory rate >= 30 per minute • Oxygen Saturation < 93% • Po2/Fio2 < 300 • Lung infiltrates > 50% in chest X-ray or Chest CT scan Iwith increasing compromise in a 24-48 hours period

1. Previous trasfusion of any hemoderivate in the 120 days prior to convalescent plasma administration 2. Active gestation

2

SEGURO SOCIAL DE SALUD;

18

100

Peru

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

192

Outcome name:Clinical evaluation of patient requirements of O2 reservoir mask or high flux O2 or Non-Invasive ventilation with O2Clinical evaluation of patient requirements of mechanical ventilation or extracorporeal oxygenation (ECMO)Clinical evaluation or report of death statusReport of adverse events attributables to convalescent plasmaMeasure:Oxygen RequirementVentilation RequirementDeathAdverse EventsTimepoints:Day 14 and 28 after plasma administrationDay 14 and 28 after plasma administrationDay 14; 28 and 56 after plasma administrationDuring first 28 days after plasma administration

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"}]