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

Centro Medico ABC

Status and phase: Terminated; Phase 3

Conditions: Covid-19

Treatments: Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients; Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04432103

ABC-20-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Severe COVID-19 pneumonia

Experimental group

Description:

Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma

Treatment:

Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients

Critical COVID- 19 pneumonia

Experimental group

Description:

Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma

Treatment:

Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients