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Convalescent Plasma Compared to Anti-COVID-19 Human Immunoglobulin and Standard Treatment (TE) in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT04395170
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Lifefactors Zona Franca, SAS

Brief Summary:
A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Biological: COVID-19 convalescent plasma Biological: Anti-COVID-19 human immunoglobulin Drug: Standard (specific) therapy for COVID-19 Phase 2 Phase 3

Detailed Description:

The study population will be patients (≥18 years) hospitalized by COVID-19 but still with an early form of the disease (in states 1-3 of the ordinal scale) who do not require mechanical ventilation (invasive or non-invasive) and who can give their consent informed.

All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:

Experimental arm 1: Plasma with inactivation/reduction of pathogens from convalescent patients with COVID-19 and who at the same time receive support therapy, in the 200 - 250 mL scheme, on days 1 and 3 of the intervention.

Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.

Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.

This arm will be included once available. The supply of anti-COVID-19 human immunoglobulin produced by LifeFactors will be carried out once the national regulatory agency (Invima) grants authorization and/or the regulatory requirements for the production of medications are met.

Control arm: Standard (specific) therapy for COVID-19 according to the suggested pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are determined by the Colombian Health Regulatory Authorities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) Compared to Anti-COVID-19 Human Immunoglobulin and Standard Treatment in Hospitalized Patients
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convalescent plasma
Plasma from patients recovering from COVID-19.
Biological: COVID-19 convalescent plasma
Plasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.

Experimental: Anti-COVID-19 human immunoglobulin
Anti-COVID-19 human immunoglobulin to be administered intravenously.
Biological: Anti-COVID-19 human immunoglobulin

Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment.

Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment.

The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met.


Active Comparator: Standard (specific) therapy

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.

To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Drug: Standard (specific) therapy for COVID-19

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.

To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.





Primary Outcome Measures :
  1. Admission to ICU and/or mechanical ventilation [ Time Frame: One year ]
    Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: One year ]
    Time in the hospital from admission to discharge or death.

  2. Neutralizing antibody (IgG) titers against COVID-19 [ Time Frame: One year ]
    Neutralizing antibody (IgG) titers against COVID-19

  3. Safety - Adverse events [ Time Frame: One year ]
    Non-serious adverse events (NSAEs) and serious adverse events (SAEs)

  4. Death [ Time Frame: One year ]
    Overall mortality



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:

  1. Obtaining the informed written consent before carrying out the study procedures, by the patients.
  2. Adult patients ≥18 years at the time of recruitment for the study.
  3. Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen <72 hours before randomization.
  4. Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:

    1. Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.),
    2. Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen.
  5. Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).
  6. Patients who do not have more than 10 days between the onset of symptoms (fever or cough) and the day of administration of treatment or the demonstration of the absence of anti-SARS-CoV-2 antibodies (patients with more than 10 days of symptoms they can only be included if a negative antibody result has been confirmed).

Exclusion Criteria:

  1. Patient in a state of pregnancy.
  2. Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
  3. Participation in any other clinical trial of an experimental treatment for COVID-19.
  4. At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
  5. Any incompatibility or allergy to the administration of plasma of human origin.
  6. Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate <30).
  7. Any condition that in the investigator's opinion limits participation in the study.

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): NCT04395170


Contacts
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Contact: Santiago Jaramillo +573128092776 sjaramillo@lifefactors.co

Sponsors and Collaborators
Lifefactors Zona Franca, SAS

Publications of Results:
Francis F, Hall M, Surg, Gaines A. Early use of convalescent serum in influenza. Mil Surg. 1920;47:177-9.
rice H, Genereux M, Sinclair C. Hyperimmune Immunoglobulin G. In: Production of Plasma Proteins for Therapeutic Use [Internet]. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2012.
Redden WR. Treatment of Influenza-Pneumonia by Use of Convalescent Human Serum. Bost Med Surg J. 1919 Dec 11;181(24):688-91.
Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from Ebola Virus Disease for Transfusion, as an Empirical Treatment during Outbreaks Interim Guidance for National Health Authorities and Blood Transfusion Services Use of Convale. 2014.
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA [Internet]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

Other Publications:
Cancer Institute N. Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Internet]. 2017. Available from: https://www.meddra.org/

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Responsible Party: Lifefactors Zona Franca, SAS
ClinicalTrials.gov Identifier: NCT04395170    
Other Study ID Numbers: LFCOLCOVID-19-001
First Posted: May 20, 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
Plan Description: 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 Lifefactors Zona Franca, SAS:
coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs