Clinical trial NCT04432103: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid-19
Keywords: covid-19
pneumonia
pandemic
convalescent plasma
Lead sponsor: Centro Medico ABC
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility 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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Primary outcomes:
measure: INCIDENCE OF CRITICAL PNEUMONIA
timeFrame: 14 days after convalescent plasma administration
measure: MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
timeFrame: 28 days after convalescent plasma administration
Secondary outcomes:
measure: INCIDENCE OF MECHANICAL VENTILATION
timeFrame: 14 days after convalescent plasma treatment
measure: DAYS OF MECHANICAL VENTILATION
timeFrame: 28 days after convalescent plasma treatment
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Abc
Study officials:
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
name: Francisco Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
name: Irma Hoyo, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
name: Benjamín Valente, MD MSc DTMH
role: PRINCIPAL_INVESTIGATOR
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