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Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

Primary Purpose

Coronavirus Disease 2019 (COVID-19)

Status

Unknown status

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

COVID-19 convalescent plasma

Anti-COVID-19 human immunoglobulin

Standard (specific) therapy for COVID-19

About this trial

This is an interventional treatment trial for Coronavirus Disease 2019 (COVID-19) focused on measuring coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Obtaining the informed written consent before carrying out the study procedures, by the patients.
Adult patients ≥18 years at the time of recruitment for the study.
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.
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.
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).
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:

Patient in a state of pregnancy.
Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
Participation in any other clinical trial of an experimental treatment for COVID-19.
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.
Any incompatibility or allergy to the administration of plasma of human origin.
Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate <30).
Any condition that in the investigator's opinion limits participation in the study.

Sites / Locations

LifeFactors Zona Franca SAS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Convalescent plasma

Anti-COVID-19 human immunoglobulin

Standard (specific) therapy

Arm Description

Plasma from patients recovering from COVID-19.

Anti-COVID-19 human immunoglobulin to be administered intravenously.

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.

Outcomes

Primary Outcome Measures

Admission to ICU and/or mechanical ventilation

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

Length of hospital stay

Time in the hospital from admission to discharge or death.

Neutralizing antibody (IgG) titers against COVID-19

Safety - Adverse events

Non-serious adverse events (NSAEs) and serious adverse events (SAEs)

Death

Overall mortality

Full Information

NCT ID

NCT04395170

First Posted

May 15, 2020

Last Updated

July 8, 2020

Sponsor

Lifefactors Zona Franca, SAS

1. Study Identification

Unique Protocol Identification Number

NCT04395170

Brief Title

Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

Official Title

A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lifefactors Zona Franca, SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019 (COVID-19)

Keywords

coronavirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Convalescent plasma

Arm Type

Experimental

Arm Description

Plasma from patients recovering from COVID-19.

Arm Title

Anti-COVID-19 human immunoglobulin

Arm Type

Experimental

Arm Description

Anti-COVID-19 human immunoglobulin to be administered intravenously.

Arm Title

Standard (specific) therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

COVID-19 convalescent plasma

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Anti-COVID-19 human immunoglobulin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Standard (specific) therapy for COVID-19

Intervention Description

Primary Outcome Measure Information:

Title

Admission to ICU and/or mechanical ventilation

Description

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.

Time Frame

One year

Secondary Outcome Measure Information:

Title

Length of hospital stay

Description

Time in the hospital from admission to discharge or death.

Time Frame

One year

Title

Neutralizing antibody (IgG) titers against COVID-19

Description

Neutralizing antibody (IgG) titers against COVID-19

Time Frame

One year

Title

Safety - Adverse events

Description

Non-serious adverse events (NSAEs) and serious adverse events (SAEs)

Time Frame

One year

Title

Death

Description

Overall mortality

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Obtaining the informed written consent before carrying out the study procedures, by the patients. Adult patients ≥18 years at the time of recruitment for the study. 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. 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: Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.), Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen. 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). 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: Patient in a state of pregnancy. Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination. Participation in any other clinical trial of an experimental treatment for COVID-19. 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. Any incompatibility or allergy to the administration of plasma of human origin. Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate <30). Any condition that in the investigator's opinion limits participation in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Santiago Jaramillo

Phone

+573128092776

sjaramillo@lifefactors.co

Facility Information:

Facility Name

LifeFactors Zona Franca SAS

City

Medellín

State/Province

Antioquia

Country

Colombia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Santiago Jaramillo

Phone

+57 3128092776

sjaramillo@lifefactors.co

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No.

Citations:

Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

Vargas M, Segura A, Wu YW, Herrera M, Chou ML, Villalta M, Leon G, Burnouf T. Human plasma-derived immunoglobulin G fractionated by an aqueous two-phase system, caprylic acid precipitation, and membrane chromatography has a high purity level and is free of detectable in vitro thrombogenic activity. Vox Sang. 2015 Feb;108(2):169-77. doi: 10.1111/vox.12209. Epub 2014 Dec 3.

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Citation

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Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.

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