CONVALESCENT PLASMA AS TREATMENT FOR COVID-19

Not Applicable

Suspended

• Conditions: -B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-013-20
• Lead Sponsor: SEGURO SOCIAL DE SALUD,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-25
• Study Completion: 2021-05-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 64

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 < 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Time in days from plasma administration until ventilation use<br><br>Measure:Time to ventilation<br><br>Timepoints:During first 28 days after plasma administration<br>