Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Patients 13-17 y.o.
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03206346|
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human Acute Respiratory Infection Viral Infection Common Cold||Drug: Ingavirin Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised Double-blind Placebo Controlled Multicenter Clinical Trial of Efficacy and Safety of Ingavirin® Capsules 30mg, in Daily Dose 60mg for the Treatment of Influenza and Other Acute Respiratory Viral Infections at Patients 13-18 y.o.|
|Actual Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||August 2013|
Broad spectrum antiviral drug
Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.
Other Name: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo oral capsule
Placebo capsule identical in appearance to Ingavirin capsule
Drug: Placebo oral capsule
Placebo, capsules daily for 5 days.
- Time to resolution of fever [ Time Frame: 7 ± 1 days ]Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС)
- Time to resolution of intoxication symptoms [ Time Frame: 7 ± 1 days ]Time from the start of study treatment to resolution of all intoxication symptoms.
- Time to resolution of catarrhal symptoms [ Time Frame: 7 ± 1 days ]Time from the start of study treatment to resolution of all catarrhal symptoms.
- Time to resolution/alleviation of cough [ Time Frame: 7 ± 1 days ]Time from the start of study treatment to resolution/alleviation of cough
- Proportion of subjects with development of complications of Influenza or other acute respiratory viral infection [ Time Frame: 7 ± 1 days and 21 ± 1 days ]Proportion of subjects who developed complications during treatment period (7 ± 1 days) and follow-up period (21 ± 1 days)
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): NCT03206346
|GBOU VPO "Kazan State Medical University" of Ministry of Health of Russian Federation|
|Kazan', Russian Federation, 420012|
|City Pediatric Outpatient Clinic number 5|
|Perm, Russian Federation, 614066|
|Research Institute of Influenza, Ministry of Healthcare of Russian Federation|
|Saint Petersburg, Russian Federation, 197376|
|Saratov State Medical University named after V. I. Razumovsky|
|Saratov, Russian Federation, 410012|
|GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation|
|Yaroslavl, Russian Federation, 150000|
|Study Director:||Ekaterina Zakharova, MD, PhD||Valenta Pharm JSC|