Convalescent Plasma for the Treatment of Severe SARS-CoV-2 (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04391101|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS-Cov-2||Drug: Convalescent plasma||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||231 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: 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.
Drug: Convalescent plasma
400-500ml convalescent plasma
Other Name: Plasma
No Intervention: 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.
- Intrahospital mortality from any cause [ Time Frame: Up to 28 days ]Proportion of patients who die while being hospitalized
- Length of hospital stay [ Time Frame: Up to 60 days ]Number of days hospitalized
- Free time for ventilatory support on day 60 [ Time Frame: Day 60 ]Number of days without ventilatory support
- Overall survival at day 60 since hospitalization [ Time Frame: 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 [ Time Frame: Up to 28 days ]Proportion of adverse events related with convalescent plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391101
|Contact: Oliver G Perilla Suarez, Hematologistemail@example.com|
|Contact: Fabian A Jaimes Barragan, Epidemiolfirstname.lastname@example.org|
|Principal Investigator:||Oliver Perilla Suarez, Hematologist||Hospital San Vicente Fundación|