Back to resultsTreatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Primary Purpose
Covid-19
Status
Terminated
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients
Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring covid-19, pneumonia, pandemic, convalescent plasma
Eligibility 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
-
Sites / Locations
- Centro Medico Abc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Severe COVID-19 pneumonia
Critical COVID- 19 pneumonia
Arm Description
Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma
Outcomes
Primary Outcome Measures
INCIDENCE OF CRITICAL PNEUMONIA
progression to critical stage
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
mortality
Secondary Outcome Measures
INCIDENCE OF MECHANICAL VENTILATION
time to need mechanical ventilation
DAYS OF MECHANICAL VENTILATION
time of mechanical ventilation needed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04432103
Brief Title
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Official Title
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Medico ABC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
covid-19, pneumonia, pandemic, convalescent plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe COVID-19 pneumonia
Arm Type
Experimental
Arm Description
Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
Arm Title
Critical COVID- 19 pneumonia
Arm Type
Experimental
Arm Description
Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma
Intervention Type
Biological
Intervention Name(s)
Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
INCIDENCE OF CRITICAL PNEUMONIA
Description
progression to critical stage
Time Frame
14 days after convalescent plasma administration
Title
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
Description
mortality
Time Frame
28 days after convalescent plasma administration
Secondary Outcome Measure Information:
Title
INCIDENCE OF MECHANICAL VENTILATION
Description
time to need mechanical ventilation
Time Frame
14 days after convalescent plasma treatment
Title
DAYS OF MECHANICAL VENTILATION
Description
time of mechanical ventilation needed
Time Frame
28 days after convalescent plasma treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Moreno, MD
Organizational Affiliation
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irma Hoyo, MD PHD
Organizational Affiliation
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamín Valente, MD MSc DTMH
Organizational Affiliation
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Abc
City
Mexico City
ZIP/Postal Code
01120
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
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