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Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19 (EPCOvid-1)

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ClinicalTrials.gov Identifier: NCT04388410
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
Hospital San Jose Tec de Monterrey
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Cardiologia Ignacio Chavez
Hospital General Dr. Manuel Gea González
Hospital Regional de Alta Especialidad del Bajio
Instituto Nacional de Cancerologia de Mexico
Information provided by (Responsible Party):
Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:
This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: convalescent plasma Phase 2 Phase 3

Detailed Description:

A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive:

Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or Normal saline solution in a similar plasma bag. Both products will be covered in an identical material to avoid identification of the infused product.

Primary endpoint:

Improvement on the 8 point WHO scale over 28 days.

Secondary endpoints.

Mortality at day 28

  • Presence of antibodies against SARS-CoV-2 in serum on days 0, 3, 7, 14, 21 y 28 after plasma administration, as long as the patient remains in the hospital.
  • Disease progression to a worse stage compared to the baseline on admission to the study according to SOFA scale.
  • Disease progression to a worse stage defined as worsening in at least two categories in the OMS disease scale on different timelines in comparison to baseline on admission to the study
  • Number of hours on mechanical ventilation in those who enter the study on mechanical ventilation.
  • Number of days with fever defined as temperature >38°C on at least one occasion during the day

Inclusion criteria:

  1. Adults older than 18 years.
  2. Confirmed SARS-CoV2 infection
  3. Patient hospitalized for COVID 19
  4. Severe disease or risk for severe disease
  5. Informed consent from patient or responsible person.

Exclusion criteria

  1. History of allergic reactions to blood products
  2. SOFA scale >12 points
  3. Absolute contraindication for administration of plasma
  4. Participation in other blinded clinical trial
  5. Projected life expectancy less than 3 months
  6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, multicenter, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Encasement of plasma and saline bags with an identical material will be done in Blood bank
Primary Purpose: Treatment
Official Title: Phase 2b/3 Trial to Evaluate the Safety and Efficacy of Plasma Transfusion From Convalescent Patients With SARS-CoV-2 Infection on Severity and Mortality of COVID-19 in Hospitalized Patients.
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: convalescent plasma
Convalescent plasma obtained from volunteers who have recovered from COVID 19. Enclosed with a similar material as the control
Biological: convalescent plasma
Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.

Placebo Comparator: Normal saline
Normal saline solution in 200 ml plasma bags enclosed with with a similar material as the plasma
Biological: convalescent plasma
Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.




Primary Outcome Measures :
  1. Severity and death [ Time Frame: 28 days ]
    Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.

  2. Adverse events that require study treatment interruption [ Time Frame: During the 28 day of follow up ]
    Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention that require interruption of study treatment. Including but not limited to: Severe allergic reactions (rash and fever), transfusion-associated lung injury (TRALI), transfusion-associated circulatory overload (TACO), and other severe unexpected events


Secondary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 28 days ]
    Time (in days) to improvement in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study.

  2. Severity and death [ Time Frame: Days 1, 3, 5, 7, 12, 14, and 21. ]
    Ordinal 8-point severity outcome scale: 1 Death, 2 Hospitalized, intubated and receiving mechanical ventilation and additional organ support (eg. renal replacement therapy, vasopressors, extracorporeal membrane oxygenation), 3 Hospitalized, intubated and receiving mechanical ventilation but no additional organ support, 4 Hospitalized receiving non-invasive ventilation of high-flow oxygen, 5 Hospitalized, receiving supplementary oxygen by mask or nasal prongs, 6 Hospitalized, no oxygen therapy needed, 7 Not-hospitalized (ambulatory) with limited activity, 8 Not-hospitalized (ambulatory) with no limitation of activities.

  3. Antibodies against SARS-CoV-2 [ Time Frame: Days 0, 3, 7, 14, 21, 28 ]
    Antibody titers on serum/plasma as long as the patient remains in the hospital.

  4. Disease progression 1 [ Time Frame: 28 days ]
    Changes in SOFA scale during hospitalization compared to the baseline

  5. Disease progression 2 [ Time Frame: Days 7,14, 21, 28 ]
    Changes in at least two categories in the 8-point ordinal severity scale in comparison to baseline on admission to the study

  6. Time on mechanical ventilation [ Time Frame: 28 days ]
    Time (in hours) spent receiving invasive mechanical ventilation in those who enter the study on mechanical ventilation.

  7. Number of days with fever [ Time Frame: 28 days ]
    Temperature >=38°C on at least one measurement during the day

  8. Adverse events attributed to the study intervention [ Time Frame: 28 days ]
    Any unfavorable and unintended symptom or sign (including an abnormal laboratory finding) temporally associated with the study intervention and considered related to the intervention.



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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:

  1. Adults 18 years of age and older.
  2. Confirmed SARS-CoV2 infection
  3. Hospitalized for COVID 19
  4. Severe disease or risk for severe disease
  5. Informed consent from patient or responsible person.

Exclusion Criteria:

  1. History of allergic reactions to blood products
  2. SOFA scale >12 points
  3. Absolute contraindication for administration of plasma
  4. Participation in other blinded clinical trial
  5. Projected life expectancy less than 3 months
  6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

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): NCT04388410


Contacts
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Contact: Juan G Sierra-Madero, MD +52556559675 jsmadero@yahoo.com
Contact: Alvaro Lopez-Iñiguez, MD

Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Tlalpan, Mexico, 14000
Contact: Juan Sierra Madero, MD    +525556559675    jsmadero@yahoo.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hospital San Jose Tec de Monterrey
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Cardiologia Ignacio Chavez
Hospital General Dr. Manuel Gea González
Hospital Regional de Alta Especialidad del Bajio
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Juan G Sierra-Madero, MD Department of Infectious Diseases
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Responsible Party: Juan G. Sierra Madero, Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04388410    
Other Study ID Numbers: 3380
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan to make IPD still not decided and would need approval by regulatory authorities

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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 Juan G. Sierra Madero, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
SARS-CoV-2
convalescent plasma
randomized clinical trial