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Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

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: NCT04366245
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies

Brief Summary:
Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.

Condition or disease Intervention/treatment Phase
SARS-CoV 2 Biological: Hyperimmune plasma Drug: Hidroxicloroquina + Azitromicina o Lopinavir/ritonavir + Interferon β-1b + Hidroxicloroquina Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Experimental Biological: Hyperimmune plasma
PLASMA OF CONVALESCENT COVID-19

Active Comparator: Comparator Drug: Hidroxicloroquina + Azitromicina o Lopinavir/ritonavir + Interferon β-1b + Hidroxicloroquina

Hidroxicloroquina

+ Azitromicina o Lopinavir/ritonavir + Interferon β-1b + Hidroxicloroquina





Primary Outcome Measures :
  1. Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). [ Time Frame: 30 days after enrollment ]
    Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

  2. Efficacy: Death from any cause [ Time Frame: Day +21 after randomization ]
  3. Efficacy: Need for mechanical ventilation [ Time Frame: Day +21 after randomization ]
  4. Efficacy: Any of the following analytical data after 72h of randomization. [ Time Frame: Day +21 after randomization ]
    IL-6> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / mL.

  5. Efficacy: SOFA scale ≥ 3 after 72 hours of randomization. [ Time Frame: Day +21 after randomization ]

Secondary Outcome Measures :
  1. Efficacy. Mortality on days 14 and 28. [ Time Frame: Days 14 and 28. ]
  2. Efficacy: Proportion of patients who required mechanical ventilation [ Time Frame: Until day 28 ]
  3. Efficacy: Proportion of patients who develop analytical alterations. [ Time Frame: Day +21 after randomization. ]
    IL-6> 40 pg / mL, D-dimer> 1500, ferritin> 1000ng / mL until the cure test.

  4. Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test. [ Time Frame: Day +21 after randomization ]
  5. Efficacy: PCR negative for SARS-CoV-2 [ Time Frame: On days 7, 14 and 21 ]
  6. Efficacy: Proportion of patients who required treatment with Tocilizumab [ Time Frame: Until day 21. ]
  7. Efficacy: Duration of hospitalization (days) [ Time Frame: Until day 21. ]
  8. Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample [ Time Frame: At baseline and on day 14 ]
  9. Virology and immunological variables: Total antibody quantification [ Time Frame: At baseline and on days 3, 7, 10 (while hospitalization lasts), and on days 14 and 28 (if you can return to the clinic or are still hospitalized). ]
  10. Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19. [ Time Frame: Before infusion ]


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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
  2. Patient of both sexes, and ≥18 years.
  3. SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in <72 hours before randomization.
  4. Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:

    • O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
    • Age> 65 years.
    • Presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity

Exclusion Criteria:

  1. Requirement before randomization of mechanical ventilation (invasive or non-invasive).
  2. Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer> 10 times ULN, ferritin> 1000ng / mL.
  3. Participation in another clinical trial or experimental treatment for COVID-19.
  4. In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
  5. Incompatibility or allergy to the administration of human plasma.
  6. Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR <30)
  7. Pregnant, lactating, or fertile women who are not using an effective method of contraception. It is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal 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): NCT04366245


Contacts
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Contact: Ana Cardesa Gil 697 95 69 41 ext 0034 ana.cardesa@juntadeandalucia.es

Locations
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Spain
Hospital Unversitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Ana Cardesa Gil    697 95 69 41 ext 0034    ana.cardesa@juntadeandalucia.es   
Sponsors and Collaborators
Andalusian Network for Design and Translation of Advanced Therapies
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Responsible Party: Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier: NCT04366245    
Other Study ID Numbers: PC/COVID-19
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Interferons
Ritonavir
Lopinavir
Interferon-beta
Hydroxychloroquine
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents
Adjuvants, Immunologic