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
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.
Drug: Convalescent plasma
400-500ml convalescent plasma
Other Name: Plasma
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
Hospital San Vicente Fundacion
Medellín, Antioquia, Colombia
Investigator: Oliver Perilla, Hematologist
Contact: 3136395608
gerardoperilla@gmail.com
Oliver G Perilla Suarez, Hematologist
+573136395608
gerardoperilla@gmail.com
Fabian A Jaimes Barragan, Epidemiol
+5742192420
fabian.jaimes@udea.edu.co
Oliver Perilla Suarez, Hematologist, Principal Investigator
Hospital San Vicente Fundación