CONVALESCENT PLASMA AS TREATMENT FOR COVID-19

CONVALESCENT PLASMA USE AS TREATMENT FOR HOSPITALIZED PATIENTS WITH COVID-19 IN ESSALUD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-013-20

Enrollment

192

Registered

2020-06-25

Start date

2020-06-01

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

EXPERIMENTAL GROUP Type of group

CONVALESCENT PLASMA Group name:CONTROL GROUP Type of group

STANDAR CARE

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients ≥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 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 50% in chest X-ray or Chest CT scan Iwith increasing compromise in a 24-48 hours period

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Outcome name:Clinical evaluation of patient requirements of O2 reservoir mask or high flux O2 or Non-Invasive ventilation with O2 Clinical evaluation of patient requirements of mechanical ventilation or extracorporeal oxygenation (ECMO) Clinical evaluation or report of death status Report of adverse events attributables to convalescent plasma Measure:Oxygen Requirement Ventilation Requirement Death Adverse Events Timepoints:Day 14 and 28 after plasma administration Day 14 and 28 after plasma administration Day 14, 28 and 56 after plasma administration During first 28 days after plasma administration	—

Measure

Time frame

Outcome name:Clinical evaluation of patient requirements of O2 reservoir mask or high flux O2 or Non-Invasive ventilation with O2 Clinical evaluation of patient requirements of mechanical ventilation or extracorporeal oxygenation (ECMO) Clinical evaluation or report of death status Report of adverse events attributables to convalescent plasma Measure:Oxygen Requirement Ventilation Requirement Death Adverse Events Timepoints:Day 14 and 28 after plasma administration Day 14 and 28 after plasma administration Day 14, 28 and 56 after plasma administration During first 28 days after plasma administration

—

Secondary

Measure	Time frame
Outcome name:Time in days from plasma administration until ventilation use Measure:Time to ventilation Timepoints:During first 28 days after plasma administration	—

Countries

Peru

Contacts

Public ContactAUSBERTO CHUNGA

SEGURO SOCIAL DE SALUD- ESSALUD

Bettochunga17@hotmail.com990149288

Outcome results