Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma

Phase 3TerminatedNCT04432103

Centro Medico ABC6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid-19

Interventions

Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patientsBIOLOGICAL

Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.

Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patientsBIOLOGICAL

Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Donors: 1. Age: \>18 and \<60 years 2. Body weight : \>60 kg 3. Confirmed previous SARS CoV-2 infection 4. negative SARS CoV-2 test result 5. 21 day without symptoms from the negative SARS CoV2 negative test 6. Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing. 7. Positive COVID-19 IgG antibodies 8. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies 9. Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation. Patients/recipients: 1. Age: \>18 years 2. Admitted to the ABC Medical Center facility for the treatment of COVID-19 3. Patients with severe or critical COVID-19 4. Informed consent provided by the patient or healthcare proxy Exclusion Criteria: Patients/recipients: 1\. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy 4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic Heart Disease \-

Locations (1)

Centro Medico Abc

Mexico City, Mexico

Outcomes

Primary Outcomes

INCIDENCE OF CRITICAL PNEUMONIA

progression to critical stage

Time frame: 14 days after convalescent plasma administration

MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS

mortality

Time frame: 28 days after convalescent plasma administration

Secondary Outcomes

INCIDENCE OF MECHANICAL VENTILATION

time to need mechanical ventilation

Time frame: 14 days after convalescent plasma treatment

DAYS OF MECHANICAL VENTILATION

time of mechanical ventilation needed

Time frame: 28 days after convalescent plasma treatment

Data from ClinicalTrials.gov

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