Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)

NCT ID: NCT04391101

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-12-31

Brief Summary

Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU

Detailed Description

Coronavirus infection has been declared by the World Health Organization as a pandemic. In addition to hemodynamic and ventilatory support in the intensive care unit, there is no treatment for COVID-19. Currently proposed treatments (chloroquine, antivirals, immunomodulators, among others) have low quality studies that do not prove efficacy.

Blood or plasma transfusion from convalescent patients (patients who have overcome the disease by generating a competent immune response) has been prescribed for over 100 years. In the last 15 years, convalescent plasma has been studied for the treatment of severe acute respiratory infections of viral origin, such as severe acute respiratory syndrome (SARS), avian influenza, and influenza A (H1N1). Suppressing viremia is one of the possible explanations for the efficacy of convalescent plasma treatment.

For the treatment of COVID-19, there are case series that show a clear improvement in severe patients after administration of convalescent plasma without significant adverse events. At the current crisis of the SARS-CoV-2 pandemic, in which there are no pharmacological treatments that have proven to have any therapeutic effect, it is imperative to assess the efficacy and safety of convalescent plasma transfusion in infected patients.

This is an open, randomized clinical trial with patient allocation in a 2 :1 ratio, plasma: standard management, for a superiority hypothesis. The main objective of this study is to determine the efficacy of convalescent plasma for the treatment of severe COVID-19 infection in terms of decreased in-hospital mortality.

Conditions

SARS-Cov-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Administration of two units of fresh frozen plasma (between 400 and 500 ml) obtained from convalescent patients from infection by SARS-CoV-2. Convalescent plasma is defined as the plasma of patients who had PCR confirmed SARS-CoV-2 infection, who have recovered clinically, and who have positive antibodies against SARS-CoV-2.

Group Type: EXPERIMENTAL

Convalescent plasma

Intervention Type: DRUG

400-500ml convalescent plasma

Control group

Subjects assigned to the control group will receive support treatment in the intensive care unit based on institutional management guidelines. The use of antiviral, antimalarial or anti-inflammatory drugs is allowed in both groups according to the ICU protocols.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Convalescent plasma

400-500ml convalescent plasma

Intervention Type: DRUG

Other Intervention Names

Plasma

Eligibility Criteria

Inclusion Criteria

For plasma donors:

• Over 18 years of age
• Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
• If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-2. If donation is done after 28 days of resolving symptoms, no negative control test will be required.

For plasma recipients:

• Over 18 years of age
• SARS-CoV-2 infection confirmed by PCR in any sample
• Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.

Exclusion Criteria

For plasma donors:

• Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
• Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.

For plasma receivers:

• Serious volume overload or other condition that contraindicates plasma transfusion.
• History of anaphylaxis or serious adverse reaction to plasma.
• Previous diagnosis of immunoglobulin A deficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica León XIII

UNKNOWN

Sponsor Role: collaborator

Grupo de Inmunodeficiencias primarias Universidad de Antioquia

UNKNOWN

Sponsor Role: collaborator

Clínica Universitaria Bolivariana

UNKNOWN

Sponsor Role: collaborator

Hospital Pablo Tobón Uribe

OTHER

Sponsor Role: collaborator

Clínica Rosario El Tesoro

UNKNOWN

Sponsor Role: collaborator

Clínica Las Américas

UNKNOWN

Sponsor Role: collaborator

Clínica Cardiovid

UNKNOWN

Sponsor Role: collaborator

Hospital San Vicente Fundación

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Perilla Suarez, Hematologist

Role: PRINCIPAL_INVESTIGATOR

Hospital San Vicente Fundación

Locations

Hospital San Vicente Fundacion

Medellín, Antioquia, Colombia

Countries

Colombia

Central Contacts

Oliver G Perilla Suarez, Hematologist

Role: CONTACT

gerardoperilla@gmail.com

+573136395608

Fabian A Jaimes Barragan, Epidemiol

Role: CONTACT

fabian.jaimes@udea.edu.co

+5742192420

Facility Contacts

Oliver Perilla, Hematologist

Role: primary

gerardoperilla@gmail.com

3136395608

Fabian Jaimes, Epidemiologi

Role: backup

fabian.jaimes@udea.edu.co

2192433

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id