Back to resultsEfficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
Primary Purpose
Common Cold, Influenza, Human, Acute Respiratory Infection
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Ingavirin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Respiratory Tract Infections, Acute Respiratory Viral Infection
Eligibility Criteria
Inclusion Criteria:
Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:
- Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
- Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
- Laboratory confirmation of viral origin of the disease
- Uncomplicated influenza and other acute respiratory viral infections
- Interval between onset of symptoms and enrollment to the study not more than 48 hours
- Have read, understood and signed an informed consent form
Exclusion Criteria:
- Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
- Pregnancy and Breastfeeding
- Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)
- Cancer, HIV infection, tuberculosis, including those in history
- History of alcohol and drug abuse
Sites / Locations
- State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
- N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
- State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
- North-western State Medical University named after I.I.Mechnikov
- Saratov State Medical University named after V. I. Razumovsky
- Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
- Volgograd State Medical University
- Yaroslavl State Medical University
- Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ingavirin
Placebo
Arm Description
Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
Placebo capsule identical in appearance to Ingavirin capsule
Outcomes
Primary Outcome Measures
Time to resolution of fever
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).
Secondary Outcome Measures
Time to resolution / alleviation of intoxication symptoms
Following symptoms were recorded and rated each visit, to evaluate symptoms progress:
Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
Time to resolution / alleviation of catarrhal symptoms
Following symptoms were recorded and rated each visit, to evaluate symptoms progress:
Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03154515
Brief Title
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
Official Title
Randomised Double Blind Placebo Controlled Multicenter Study for Evaluation of Clinical Efficacy and Safety of Ingavirin 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valenta Pharm JSC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.
Detailed Description
Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Influenza, Human, Acute Respiratory Infection
Keywords
Respiratory Tract Infections, Acute Respiratory Viral Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ingavirin
Arm Type
Experimental
Arm Description
Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule identical in appearance to Ingavirin capsule
Intervention Type
Drug
Intervention Name(s)
Ingavirin
Other Intervention Name(s)
Imidazolyl ethanamide pentandioic acid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to resolution of fever
Description
Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).
Time Frame
7 ± 1 days
Secondary Outcome Measure Information:
Title
Time to resolution / alleviation of intoxication symptoms
Description
Following symptoms were recorded and rated each visit, to evaluate symptoms progress:
Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
Time Frame
7 ± 1 days
Title
Time to resolution / alleviation of catarrhal symptoms
Description
Following symptoms were recorded and rated each visit, to evaluate symptoms progress:
Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
Time Frame
7 ± 1 days
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events
Description
All adverse events recorded and analysed, to compare incidence rate with one of placebo.
Complete blood count test performed at the beginning and at the end of the study.
Vital signs taken and recorded at each visit throughout the study, usually every day for 7 ± 1 days.
Time Frame
Through study completion, an average of 8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:
Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
Laboratory confirmation of viral origin of the disease
Uncomplicated influenza and other acute respiratory viral infections
Interval between onset of symptoms and enrollment to the study not more than 48 hours
Have read, understood and signed an informed consent form
Exclusion Criteria:
Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
Pregnancy and Breastfeeding
Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)
Cancer, HIV infection, tuberculosis, including those in history
History of alcohol and drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterina Zakharova, MD, PhD
Organizational Affiliation
Valenta Pharm JSC
Official's Role
Study Director
Facility Information:
Facility Name
State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
City
Moscow
ZIP/Postal Code
123098
Country
Russian Federation
Facility Name
State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
City
Novosibirsk
Country
Russian Federation
Facility Name
North-western State Medical University named after I.I.Mechnikov
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Saratov State Medical University named after V. I. Razumovsky
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
City
Vladivostok
ZIP/Postal Code
690002
Country
Russian Federation
Facility Name
Volgograd State Medical University
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
Yaroslavl State Medical University
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
City
Yekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
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