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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391101
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Hospital San Vicente Fundación

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

Condition or disease Intervention/treatment Phase
SARS-Cov-2 Drug: Convalescent plasma Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 231 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Intrahospital mortality from any cause [ Time Frame: Up to 28 days ]
    Proportion of patients who die while being hospitalized


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 60 days ]
    Number of days hospitalized

  2. Free time for ventilatory support on day 60 [ Time Frame: Day 60 ]
    Number of days without ventilatory support

  3. Overall survival at day 60 since hospitalization [ Time Frame: Day 60 ]
    Proportion of patients alive on day 60

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Oliver G Perilla Suarez, Hematologist +573136395608 gerardoperilla@gmail.com
Contact: Fabian A Jaimes Barragan, Epidemiol +5742192420 fabian.jaimes@udea.edu.co

Locations
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Colombia
Hospital San Vicente Fundacion
Medellín, Antioquia, Colombia
Contact: Oliver Perilla, Hematologist    3136395608    gerardoperilla@gmail.com   
Contact: Fabian Jaimes, Epidemiologi    2192433    fabian.jaimes@udea.edu.co   
Sponsors and Collaborators
Hospital San Vicente Fundación
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
Investigators
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Principal Investigator: Oliver Perilla Suarez, Hematologist Hospital San Vicente Fundación
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Responsible Party: Hospital San Vicente Fundación
ClinicalTrials.gov Identifier: NCT04391101    
Other Study ID Numbers: 002
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital San Vicente Fundación:
Coronavirus
Covid-19
Convalescent plasma
Intensive Care Unit