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Effectiveness and Safety of Convalescent Plasma in Patients With High-risk 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: NCT04425837
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Guillermo Enrique Quintero-Vega, Fundación Santa Fe de Bogota

Brief Summary:
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Covid-19 Biological: SARS-CoV-2 convalescent plasma treatment Other: Standard care Phase 2 Phase 3

Detailed Description:

This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).

Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. Outcomes will be measured as follows:

* Group of patients with critical illness:

Primary outcomes (Effectiveness and safety):

  • Mortality
  • Safety: Presence of adverse events

Secondary outcomes:

  • Intensive care unit length of stay
  • Evolution of clinical and paraclinical aspects.

    • Group of patients at high risk of progression:

Primary outcomes (Effectiveness and safety):

  • Mortality
  • Safety: Presence of adverse events
  • Admission to ICU in 30 days
  • Mechanical ventilation requirement

Secondary outcomes:

  • Hospital/Intensive care unit length of stay
  • Evolution of clinical and paraclinical aspects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Active Comparator: Standard care alone Other: Standard care
Standard care according to guidelines and national regulations

Experimental: SARS-CoV-2 convalescent plasma treatment plus standard care Biological: SARS-CoV-2 convalescent plasma treatment
Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration

Other: Standard care
Standard care according to guidelines and national regulations




Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days after the study enrollment ]
    Death of the patient (yes/no)

  2. Adverse events [ Time Frame: Up to 30 days after the study enrollment ]

    Presence of any of the following adverse events (yes/no):

    1. Nonhemolytic febrile reactions
    2. Allergic reactions
    3. Acute hemolytic reactions
    4. Non-immune hemolysis
    5. Acute transfusion-related lung damage
    6. Transfusion-related circulatory overload
    7. Metabolic reactions
    8. Hypotensive reactions
    9. Delayed hemolytic reactions
    10. Post transfusion purple
    11. Graft versus host disease
    12. Bacterial contamination of blood components
    13. Viral infections
    14. Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)

  3. ICU admission [ Time Frame: Up to 30 days after the study enrollment ]
    Admitted to intensive care units (ICUs) (yes/no)

  4. Mechanical ventilation [ Time Frame: Up to 30 days after the study enrollment ]
    Mechanical ventilation requirement (yes/no)


Secondary Outcome Measures :
  1. ICU length [ Time Frame: Up to 30 days after the study enrollment ]
    Intensive care unit length of stay

  2. Reduction of D Dimer [ Time Frame: Assessment at day 30 after study enrollment ]
    D dimer reduction below 1mcg / ml

  3. LDH reduction [ Time Frame: Assessment at day 30 after study enrollment ]
    Reduction of LDH below 350 IU / L

  4. Reduction of Troponin level [ Time Frame: Assessment at day 30 after study enrollment ]
    Reduction of troponin level to than 8 pg / mL

  5. Decrease in ferritin level [ Time Frame: Assessment at day 30 after study enrollment ]
    Decrease in ferritin level below 1025 mcg / L

  6. Decrease in procalcitonin level [ Time Frame: Assessment at day 30 after study enrollment ]
    Decrease in procalcitonin level below 0.1ng / ml

  7. Decrease in CRP [ Time Frame: Assessment at day 30 after study enrollment ]
    Decrease in CRP level bellow <8 mg / L

  8. Increase in lymphocyte count [ Time Frame: Assessment at day 30 after study enrollment ]
    Increase in lymphocyte count greater than 0.6 x 10-9 / L

  9. Increase in PaO2 / Fio2 [ Time Frame: Assessment at day 30 after study enrollment ]
    Increase in PaO2 / Fio2 greater than 200

  10. Decrease in Sequential Organ failure assessment (SOFA ) score [ Time Frame: Assessment at day 30 after study enrollment ]
    Scale of 24 points, greater number indicates worst outcome

  11. Extracorporeal membrane oxygenation (ECMO) [ Time Frame: Assessment at day 30 after study enrollment ]
    Extracorporeal membrane oxygenation requirement (ECMO)

  12. Lung infiltration [ Time Frame: Assessment at day 30 after study enrollment ]
    Decrease in the percentage of lung infiltration



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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:

All patients

  • Patients diagnosed with COVID-19 infection by RT-PCR technique
  • Patients ≥ 18 years of age
  • Patients in standard care according to the national guide
  • Onset of symptoms ≤ 14 days
  • Signature of informed consent report

Patients at high risk of progression, defined by all of the following:

  • Score greater than 9 on the CALL scale
  • Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)
  • X-ray or CT compatible with pneumonia
  • Hospitalized patients

Critically ill patients, defined by any of the following:

  • Mechanical ventilation requeriment
  • Patients in Intensive Care Unit or Intermediate Care Unit
  • Ventilatory failure, septic shock, dysfunction or multi-organ failure

Exclusion Criteria:

  • Negative RT-PCR result from secretion 48 hours prior to study recruitment
  • History of allergic reaction to blood or plasma in patients with a known history of IgA deficiency
  • Patients participating in other clinical trial
  • History of allergy to blood products
  • History of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment
  • Pregnant women

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): NCT04425837


Contacts
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Contact: Guillermo E Quintero, Hematologist 5716030303 ext 1221 quiquequintero@yahoo.com.mx
Contact: José A De la Hoz, Epidemiologist 5716030303 ext 1127 jose.delahoz@fsfb.org.co

Locations
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Colombia
Fundación Santa Fe de Bogotá
Bogotá, Cundinamarca, Colombia, 110111
Contact: José De la Hoz, Epidemiologist    5716030303 ext 1127    jose.delahoz@fsfb.org.co   
Sponsors and Collaborators
Fundación Santa Fe de Bogota
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Responsible Party: Guillermo Enrique Quintero-Vega, Hematologist, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT04425837    
Other Study ID Numbers: PLASMA COVID-19
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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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 Guillermo Enrique Quintero-Vega, Fundación Santa Fe de Bogota:
COVID-19 serotherapy
Mortality
Safety