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

Phase 3

Terminated

• Conditions: Covid-19
• Interventions: Biological: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients; Biological: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients

• Registration Number: NCT04432103
• Lead Sponsor: Centro Medico ABC

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.

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2020-08-08
• Primary Completion: 2021-01-29
• Study Completion: 2021-01-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe COVID-19 pneumonia	Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients	Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
Critical COVID- 19 pneumonia	Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients	Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centro Medico Abc; 🇲🇽 Mexico City, Mexico