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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04432103

Enrollment

Registered

2020-06-16

Start date

2020-08-08

Completion date

2021-01-29

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Keywords

covid-19, pneumonia, pandemic, convalescent plasma

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.

Interventions

BIOLOGICALAnti 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.

BIOLOGICALAnti 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \-

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026