Common ColdPhase 4NCT03154515
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
A Phase 4 study testing Ingavirin in people with Common Cold and Influenza, Human, run by Valenta Pharm JSC at 9 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Common Cold, Influenza, Human, Acute Respiratory Infection
- What is being tested?
- Ingavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 445 participants
- Where
- 9 sitesRussia
- Study dates
- Jan 2010to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"
Chelyabinsk, 454092
N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology
Moscow, 123098
State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"
Novosibirsk
North-western State Medical University named after I.I.Mechnikov
Saint Petersburg, 195067
Saratov State Medical University named after V. I. Razumovsky
Saratov, 410012
Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation
Vladivostok, 690002
Volgograd State Medical University
Volgograd, 400131
Yaroslavl State Medical University
Yaroslavl, 150000
Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, 620028
About this study
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.
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.
Read the 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).
- Conditions
- Common Cold, Influenza, Human, Acute Respiratory Infection
- Being tested
- Ingavirin, Placebo
- Keywords
- Respiratory Tract Infections, Acute Respiratory Viral Infection
- Medical subject headings
- Common Cold, Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IngavirinDrug
Also called Imidazolyl ethanamide pentandioic acid
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ingavirin | Experimental | Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days Receives: Drug: Ingavirin |
| Placebo | Placebo comparator | Placebo capsule identical in appearance to Ingavirin capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 ± 1 days
Secondary outcomes (2)
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.
Measured: 7 ± 1 days
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.
Measured: 7 ± 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJan 2010
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekaterina Zakharova, MD, PhD, Study director, Valenta Pharm JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154515
- Sponsor's protocol ID
- 5P/08
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03154515
- Acronym / sponsor ID
- 5P/08
- Conditions
- Common Cold, Influenza, Human, Acute Respiratory Infection
- Keywords
- Respiratory Tract Infections, Acute Respiratory Viral Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingavirin | Experimental | Drug: IngavirinImidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule identical in appearance to Ingavirin capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IngavirinAlso: Imidazolyl ethanamide pentandioic acid | Drug | Ingavirin |
| Placebo | Drug | Placebo |
Primary outcome
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, till the end of the follow up).
2 secondary outcomes
Time to resolution / alleviation of intoxication symptoms
Time frame: 7 ± 1 days
Time to resolution / alleviation of catarrhal symptoms
Time frame: 7 ± 1 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Zakharova, MD, PhD study director
Valenta Pharm JSC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ingavirin in people with Common Cold and Influenza, Human, run by Valenta Pharm JSC at 9 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of fever (time frame: 7 ± 1 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.