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

July 30, 2021 updated by: Centro Medico ABC
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 01120
        • Centro Médico ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Medico ABC

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2020

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC-20-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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