Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

• Sponsor: Valenta Pharm JSC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03154515
• Collaborator: (none)
• Enrollment: 445
• Locations: 9
• Arms: 2
• Actual Duration (Months): 57
• Patients Per Site: 49.4
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold; Influenza, Human; Acute Respiratory Infection	Drug: Ingavirin; Drug: Placebo	Phase 4

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 445 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double Blind
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ingavirin Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days	Drug: Ingavirin; Other Names: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo Placebo capsule identical in appearance to Ingavirin capsule	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Time to resolution of fever [7 ± 1 days]

   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

1. Time to resolution / alleviation of intoxication symptoms [7 ± 1 days]

   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.

2. Time to resolution / alleviation of catarrhal symptoms [7 ± 1 days]

   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.

Other Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [Through study completion, an average of 8 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"	Chelyabinsk		Russian Federation	454092
2	N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology	Moscow		Russian Federation	123098
3	State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"	Novosibirsk		Russian Federation
4	North-western State Medical University named after I.I.Mechnikov	Saint Petersburg		Russian Federation	195067
5	Saratov State Medical University named after V. I. Razumovsky	Saratov		Russian Federation	410012
6	Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation	Vladivostok		Russian Federation	690002
7	Volgograd State Medical University	Volgograd		Russian Federation	400131
8	Yaroslavl State Medical University	Yaroslavl		Russian Federation	150000
9	Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation	Yekaterinburg		Russian Federation	620028

Sponsors and Collaborators

• Valenta Pharm JSC

Investigators

• Study Director: Ekaterina Zakharova, MD, PhD, Valenta Pharm JSC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valenta Pharm JSC
• ClinicalTrials.gov Identifier: NCT03154515
• Other Study ID Numbers: 5P/08
• First Posted: May 16, 2017
• Last Update Posted: May 16, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Valenta Pharm JSC: Respiratory Tract Infections; Acute Respiratory Viral Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Common Cold; Pentanedioic acid imidazolyl ethanamide

Study Results

No Results Posted as of May 16, 2017