Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-01 @ 7:48 AM
Study NCT ID:
NCT05386459
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2022-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Use of the Drug Ingaron in Patients With COVID-19
Sponsor:
SPP Pharmaclon Ltd.
Organization:
Study Overview
Official Title:
Prospective Two-week Open-label Application Experimental Randomized Single-center Non-interventional Study of the Drug Ingaron in Patients With a New Coronavirus Infection COVID-19
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
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:
Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral immune response, while it also has its own antiviral activity. The objective of this study was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN: recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular and subcutaneous administration of 500,000 IU) in patients with viral pneumonia.
Detailed Description:
The study drug was prescribed for therapeutic purposes according to the following scheme:
500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed.
The main stages of the study:
screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily).
The total duration of observation is up to 14 days. Patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.
500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits 0 and 1 could be combined provided that the chronological sequence of screening and randomization procedures was followed.
The main stages of the study:
screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of the investigational medicinal product for 5 days (from the first day of the basic therapy, daily).
The total duration of observation is up to 14 days. Patients who completed participation in the study or dropped out of the study ahead of schedule were followed up by the attending physician in accordance with the rules for managing such patients for a medical institution.
Study Oversight
Has Oversight DMC:
False
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?: