Influenza, HumanPhase 3NCT03189537
Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections
A Phase 3 study testing Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 2 sites in Russia.
Trial summary
The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Human, Acute Respiratory Infection, Common Cold
- What is being tested?
- Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesRussia
- Study dates
- 3 Oct 2010to 10 Oct 2011
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season
- First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours
- Signed Informed Contest to participate in the study
- Contraception throughout the study
Who cannot join
- Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion
- Anti-virals intake, other then investigational drug, throughout the study
- Vaccination for Influenza less than 1 year before inclusion
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Research Institute of Influenza
Saint Petersburg, 197376
Saratov State Medical University named after V. I. Razumovsky
Saratov, 410012
About this study
Official title: Double Blind Randomised Placebo Controlled Trial for Evaluation of Efficacy and Safety of Ingavirin® for Post-exposure Profilaxis During Rise in the Incidence of Influenza and Other Acute Respiratory Viral Infections in Adults
The purpose of the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections
Read the detailed description
The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.
The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.
Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.
Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.
The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.
Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.
- Conditions
- Influenza, Human, Acute Respiratory Infection, Common Cold, Flu, Viral Infection
- Being tested
- Ingavirin (Imidazolyl Ethanamide Pentandioic Acid), Placebo oral capsule
- Keywords
- Profilaxis, Ingavirin
- Medical subject headings
- Influenza, Human, Common Cold, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)Drug
Broad-spectrum antiviral agent
Placebo oral capsuleDrug
Placebo capsule to match Ingavirin capsule
| Study group | Role | What they receive |
|---|---|---|
| Ingavirin | Experimental | Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days Receives: Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) |
| Placebo | Placebo comparator | Placebo oral capsule, once daily for 7 days Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)*100% then divided by incidence in placebo group.
Measured: Through study completion, an average of 37 days
Secondary outcomes (1)
Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri
Measured: Through study completion, an average of 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start3 Oct 2010
- Primary completion19 Apr 2011
- Study completion10 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 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
- NCT03189537
- Sponsor's protocol ID
- 2P/09
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shul'diakov AA, Liapina EP, Kuznetsov VI. [Current principles in the chemoprophylaxis of acute respiratory viral infections]. Ter Arkh. 2013;85(11):27-33. Russian.
PubMed 24432596
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomised Placebo Controlled Trial for Evaluation of Efficacy and Safety of Ingavirin® for Post-exposure Profilaxis During Rise in the Incidence of Influenza and Other Acute Respiratory Viral Infections in Adults
- ClinicalTrials.gov ID
- NCT03189537
- Acronym / sponsor ID
- 2P/09
- Conditions
- Influenza, Human, Acute Respiratory Infection, Common Cold, Flu, Viral Infection
- Keywords
- Profilaxis, Ingavirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2010 (actual)
- Primary completion
- 19 Apr 2011 (actual)
- Study completion
- 10 Oct 2011 (actual)
- First posted
- 16 Jun 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 the study was to evaluate efficacy of prophylactic Ingavirin intake by people having contact with sick people infected with influenza and other acute respiratory viral infections
Detailed description
The study includes 7 days of treatment period and 30 days of follow-up, 37 days total.
The participant was receiving Ingavirin or placebo for 7 days. Then during 30 days the participant was under supervision.
Visits were performed at days 2-7 (every day) since inclusion and then every 5 days during follow-up period.
Wherever during the study the participant developed symptoms of flu or other acute respiratory viral infection, the participant was taken for medical care to observe his condition, symptoms dynamics, lab tests, including laboratory verification of viral origin of the disease. Medical care was established for 10±2 days since symptoms. Everyday for 3 days and additional visits for 5±1 and 10±2 days of the disease.
The patient had the required symptomatic treatment, additionally the patient could be institutionalised if necessary.
Wherever the participant developed symptoms during treatment period, the patient was taken investigational drug on schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingavirin | Experimental | Drug: Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) capsules, 90 mg once daily for 7 days |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo oral capsule, once daily for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who do have continuous contact with ill person (staff members, dormitory, family members), laboratory confirmed viral origin, during influenza/other acute viral respiratory disease season
- First exposure with the ill person who is present with symptoms of flu or acute respiratory viral infection (fever, intoxication, catarrhal symptoms) ≤ 48 hours
- Signed Informed Contest to participate in the study
- Contraception throughout the study
Key exclusion criteria (4 listed)
- Interferone or interferone inducers intake, or substances with action on immune system intake less then 3 months before inclusion
- Anti-virals intake, other then investigational drug, throughout the study
- Vaccination for Influenza less than 1 year before inclusion
- Pregnant or lactating
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 |
|---|---|---|
| Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)Broad-spectrum antiviral agent | Drug | Ingavirin |
| Placebo oral capsulePlacebo capsule to match Ingavirin capsule | Drug | Placebo |
Primary outcome
Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups
Time frame: Through study completion, an average of 37 days
To evaluate incidence difference between Ingavirin and placebo groups. Incidence defined as ratio between number of people got sick in the group to all people in the group. 1) Efficiency Index (EI) was defined as incidence of flu in placebo group to incidence of flu in Ingavirin group. 2) Efficacy Ratio (ER) defined by formula: ER=(incidence in placebo group - incidence Ingavirin group)*100% then divided by incidence in placebo group.
1 secondary outcome
Comparative evaluation of prevalence and duration of flu and acute viral respiratory infection at participants who developed flu / avri
Time frame: Through study completion, an average of 37 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 Jun 2017.
- Results publication: PubMed 24432596Shul'diakov AA, Liapina EP, Kuznetsov VI. [Current principles in the chemoprophylaxis of acute respiratory viral infections]. Ter Arkh. 2013;85(11):27-33. Russian.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ingavirin (Imidazolyl Ethanamide Pentandioic Acid) in people with Influenza, Human and Acute Respiratory Infection, run by Valenta Pharm JSC at 2 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 4 inclusion and 4 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference in incidence of flu / other acute respiratory viral infections between Ingavirin and placebo groups (time frame: Through study completion, an average of 37 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189537, which also lists 1 linked publication.
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 Jun 2017.