Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04395170
Status:
UNKNOWN
Last Update Posted:
2020-07-10
First Post:
2020-05-15
Brief Title:
Convalescent Plasma PC and Human Intravenous Anti-COVID-19 Immunoglobulin IV Anti COVID-19 IgG in Patients Hospitalized for COVID-19
Sponsor:
Lifefactors Zona Franca SAS
Organization:
Lifefactors Zona Franca SAS
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inactivationreduction 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 SAS 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 andor 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
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 inactivationreduction 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 SAS 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None