Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Centro Medico ABC
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- INCIDENCE OF CRITICAL PNEUMONIA
Study Overview
Brief Summary
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
Detailed Description
We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: >18 and <60 years
- •Body weight : >60 kg
- •Confirmed previous SARS CoV-2 infection
- •negative SARS CoV-2 test result
- •21 day without symptoms from the negative SARS CoV2 negative test
- •Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- •Positive COVID-19 IgG antibodies
- •Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- •Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.
- •Patients/recipients:
- •Age: >18 years
- •Admitted to the ABC Medical Center facility for the treatment of COVID-19
- •Patients with severe or critical COVID-19
- •Informed consent provided by the patient or healthcare proxy
Exclusion Criteria
- •Patients/recipients:
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- •Any other not controlled infection
- •Disseminated Intravascular Coagulopathy
- •Patient under dialysis
- •Patient with recent Hemorrhagic Stroke
- •Severe Ischemic Heart Disease
Arms & Interventions
Severe COVID-19 pneumonia
Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
Intervention: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients (Biological)
Critical COVID- 19 pneumonia
Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma
Intervention: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients (Biological)
Outcomes
Primary Outcomes
INCIDENCE OF CRITICAL PNEUMONIA
Time Frame: 14 days after convalescent plasma administration
progression to critical stage
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
Time Frame: 28 days after convalescent plasma administration
mortality
Secondary Outcomes
- INCIDENCE OF MECHANICAL VENTILATION(14 days after convalescent plasma treatment)
- DAYS OF MECHANICAL VENTILATION(28 days after convalescent plasma treatment)