SARS-Cov-2
Conditions
Keywords
Coronavirus, Covid-19, Convalescent plasma, Intensive Care Unit
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.
Interventions
DRUGConvalescent plasma
400-500ml convalescent plasma
Sponsors
Clínica León XIII
Grupo de Inmunodeficiencias primarias Universidad de Antioquia
Clínica Universitaria Bolivariana
Hospital Pablo Tobón Uribe
Clínica Rosario El Tesoro
Clínica Las Américas
Clínica Cardiovid
Hospital San Vicente Fundación
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrahospital mortality from any cause | Up to 28 days | Proportion of patients who die while being hospitalized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Up to 60 days | Number of days hospitalized |
| Free time for ventilatory support on day 60 | Day 60 | Number of days without ventilatory support |
| Overall survival at day 60 since hospitalization | Day 60 | Proportion of patients alive on day 60 |
| Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections | Up to 28 days | Proportion of adverse events related with convalescent plasma |
Countries
Colombia
Contacts
Primary ContactOliver G Perilla Suarez, Hematologist
Backup ContactFabian A Jaimes Barragan, Epidemiol
Outcome results
None listed