Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
NCT ID: NCT04432103
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
6 participants
INTERVENTIONAL
2020-08-08
2021-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Severe COVID-19 pneumonia
Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
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.
Critical COVID- 19 pneumonia
Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
\-
18 Years
ALL
No
Sponsors
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Centro Medico ABC
OTHER
Responsible Party
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Principal Investigators
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Francisco Moreno, MD
Role: PRINCIPAL_INVESTIGATOR
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Irma Hoyo, MD PHD
Role: PRINCIPAL_INVESTIGATOR
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Benjamín Valente, MD MSc DTMH
Role: PRINCIPAL_INVESTIGATOR
ABC Medical Center Internal Medicine Department. Mexico City, Mexico
Locations
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Centro Medico Abc
Mexico City, , Mexico
Countries
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References
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Related Links
Access external resources that provide additional context or updates about the study.
WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 \[Internet\]. \[cited 2020 Mar 23\].
Johns Hopkins Coronavirus Resource Center \[Internet\]. Johns Hopkins Coronavirus Resource Center. \[cited 2020 Mar 23\].
Situation update worldwide, as of 22 March 2020 \[Internet\]. European Centre for Disease Prevention and Control. \[cited 2020 Mar 23\]
Novel Coronavirus (2019-nCoV) situation reports \[Internet\]. \[cited 2020 Mar 23\].
who-china-joint-mission-on-covid-19-final-report.pdf \[Internet\]. \[cited 2020 Mar 23\].
CDC. Coronavirus Disease 2019 (COVID-19) \[Internet\]. Centers for Disease Control and Prevention. 2020 \[cited 2020 Apr 7\].
National COVID-19 Convalescent Plasma Project \[Internet\]. \[cited 2020 Apr 8\].
Convalescent Plasma COVID-19 (Coronavirus) Treatment - Mayo Clinic \[Internet\]. \[cited 2020 Apr 8\]. Available from:
Other Identifiers
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ABC-20-14
Identifier Type: -
Identifier Source: org_study_id
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