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

SARS-Cov-2 Clinical Trial

Official title:

Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04391101
• Other study ID #: 002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2020
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Hospital San Vicente Fundación
• Contact: Oliver G Perilla Suarez, Hematologist
• Phone: +573136395608
• Email: gerardoperilla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 231
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-Cov-2

Intervention

Drug:
• Convalescent plasma
400-500ml convalescent plasma

Locations

Country	Name	City	State
Colombia	Hospital San Vicente Fundacion	Medellín	Antioquia

Sponsors (8)

Lead Sponsor	Collaborator
Hospital San Vicente Fundación	Clínica Cardiovid, Clínica Las Américas, Clínica León XIII, Clínica Rosario El Tesoro, Clínica Universitaria Bolivariana, Grupo de Inmunodeficiencias primarias Universidad de Antioquia, Hospital Pablo Tobón Uribe

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahospital mortality from any cause	Proportion of patients who die while being hospitalized	Up to 28 days
Secondary	Length of hospital stay	Number of days hospitalized	Up to 60 days
Secondary	Free time for ventilatory support on day 60	Number of days without ventilatory support	Day 60
Secondary	Overall survival at day 60 since hospitalization	Proportion of patients alive on day 60	Day 60
Secondary	Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections	Proportion of adverse events related with convalescent plasma	Up to 28 days