Trial | NCT04432103  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    6
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 Started
Aug 08
2020
Primary Completion
Jan 29
2021
Study Completion
Jan 29
2021
Last Update
Aug 02
2021

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

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.

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

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.

Severe COVID-19 pneumonia Experimental

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

Critical COVID- 19 pneumonia Experimental

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

Criteria 

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

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No Results Posted