Clinical trial NCT04391101: Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)
Official title: Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: SARS-Cov-2
Keywords: Coronavirus
Covid-19
Convalescent plasma
Intensive Care Unit
Lead sponsor: Hospital San Vicente Fundación
Sponsor class: OTHER
Collaborators: name: Clínica León XIII
name: Grupo de Inmunodeficiencias primarias Universidad de Antioquia
name: Clínica Universitaria Bolivariana
name: Hospital Pablo Tobón Uribe
name: Clínica Rosario El Tesoro
name: Clínica Las Américas
name: Clínica Cardiovid
First posted: 2020-05-18
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, parallel, randomized clinical trial with stratified (center and age) patient allocation in a 2 :1 ratio (plasma: standard management) for a superiority hypothesis
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intrahospital mortality from any cause
timeFrame: Up to 28 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Up to 60 days
measure: Free time for ventilatory support on day 60
timeFrame: Day 60
measure: Overall survival at day 60 since hospitalization
timeFrame: Day 60
measure: Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Hospital San Vicente Fundacion
state: Antioquia
Study officials:
affiliation: Hospital San Vicente Fundación
name: Oliver Perilla Suarez, Hematologist
role: PRINCIPAL_INVESTIGATOR
References: