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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432103
Recruitment Status : Terminated (There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia)
First Posted : June 16, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centro Medico ABC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid-19 Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Actual Study Start Date : August 8, 2020
Actual Primary Completion Date : January 29, 2021
Actual Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Severe COVID-19 pneumonia
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
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.
Experimental: Critical COVID- 19 pneumonia
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. INCIDENCE OF CRITICAL PNEUMONIA [ Time Frame: 14 days after convalescent plasma administration ]
    progression to critical stage

  2. MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS [ Time Frame: 28 days after convalescent plasma administration ]
    mortality


Secondary Outcome Measures :
  1. INCIDENCE OF MECHANICAL VENTILATION [ Time Frame: 14 days after convalescent plasma treatment ]
    time to need mechanical ventilation

  2. DAYS OF MECHANICAL VENTILATION [ Time Frame: 28 days after convalescent plasma treatment ]
    time of mechanical ventilation needed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432103


Locations
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Mexico
Centro Medico Abc
Mexico City, Mexico, 01120
Sponsors and Collaborators
Centro Medico ABC
Investigators
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Principal Investigator: Francisco Moreno, MD ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Principal Investigator: Irma Hoyo, MD PHD ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Principal Investigator: Benjamín Valente, MD MSc DTMH ABC Medical Center Internal Medicine Department. Mexico City, Mexico
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Centro Medico ABC
ClinicalTrials.gov Identifier: NCT04432103    
Other Study ID Numbers: ABC-20-14
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro Medico ABC:
covid-19
pneumonia
pandemic
convalescent plasma
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases