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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid-19

Intervention / Treatment
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* Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients
* Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors: 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: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups depending on the stage of the disease according to the CDC of China classification severe and critical COVID-19 pneumonia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe COVID-19 pneumonia<br>Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma | Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients<br>* 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.<br>|
| Experimental: Critical COVID- 19 pneumonia<br>Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma | Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INCIDENCE OF CRITICAL PNEUMONIA | progression to critical stage | 14 days after convalescent plasma administration | 
| MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS | mortality | 28 days after convalescent plasma administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INCIDENCE OF MECHANICAL VENTILATION | time to need mechanical ventilation | 14 days after convalescent plasma treatment | 
| DAYS OF MECHANICAL VENTILATION | time of mechanical ventilation needed | 28 days after convalescent plasma treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, pneumonia, pandemic, convalescent plasma