InfluenzaPhase 2/3NCT03441373
XC8 in the Treatment of Patients With Acute Respiratory Viral Infection
A Phase 2/3 study testing XC8 20 mg, XC8 100 mg and XC8 200 mg in people with Influenza and Acute Respiratory Infection, run by PHARMENTERPRISES LLC at 18 sites in Russia.
Trial summary
A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Influenza, Acute Respiratory Infection
- What is being tested?
- XC8 20 mg, XC8 100 mg and XC8 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 18 sitesRussia
- Study dates
- 3 Feb 2016to 9 Feb 2017
- Phase
- Phase 2/3
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18 to 45 years (inclusively).
- Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.
- Uncomplicated course of ARVI or influenza.
- The onset of symptoms no more than 36h prior to the inclusion into the study.
- Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
- Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
- Signed Informant Consent Form.
Who cannot join
- The patient will be deemed ineligible for the study meeting any of the following criteria:
- Complicated course of influenza or ARVI (including the presence / development of bacterial infection).
- Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
- Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
- Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
- Infectious diseases during the last week before including into the study.
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- History of bronchial asthma.
- History of increased convulsive activity.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study).
- History of oncological diseases, HIV, tuberculosis.
- Hypersensitivity to excipients of the XC8.
- Diabetes mellitus, lactose intolerance, lactase deficiency.
- Drug or alcohol abuse.
- Participation in any other clinical trial in the last 90 days.
- Pregnancy or lactation.
- Military or prison populations.
- Impossibility or inability to comply with the study procedures.
- A member of the investigator's family or other person interested in the results of the study
- Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
- History of renal insufficiency.
- Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01.
- -
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
Izhevsk, 426063
State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
Kazan', 420012
State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Krasnodar, 350063
Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
Nizhny Novgorod, 603022
Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",
Novosibirsk, 630068
Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",
Novosibirsk, 630099
; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"
Podolsk, 142105
Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",
Rostov-on-Don, 344000
State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"
Ryazan, 390026
ArsVite Severo-Zapad LLC
Saint Petersburg, 194223
Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation
Saint Petersburg, 197110
Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg, 197376
Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"
Saint Petersburg, 197706
Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"
Saransk, 430024
State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Tomsk, , 634050
State Budgetary Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Infectious Regional Clinical Hospital № 1
Volgograd, 400131
State Budgetary Institution of Higher Professional Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Yaroslavl region State Healthcare Institution Infectious Regional Clinical Hospital # 1
Yaroslavl, 150000
State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
Yaroslavl, 150007
About this study
Official title: Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)
A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment.
The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.
Read the detailed description
Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up.
In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio:
Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients).
Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control.
In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio:
Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients).
During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.
- Conditions
- Influenza, Acute Respiratory Infection
- Being tested
- XC8 20 mg, XC8 100 mg, XC8 200 mg, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8 20 mgDrug
Also called Нistamine glutarimide
once daily during 5 days.
XC8 100 mgDrug
Also called Нistamine glutarimide
once daily during 5 days.
XC8 200 mgDrug
Also called Нistamine glutarimide
once daily during 5 days.
PlaceboDrug
once daily during 5 days.
| Study group | Role | What they receive |
|---|---|---|
| XC8 20 mg and Placebo (Group A) | Experimental | XC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period Receives: Drug: XC8 20 mg |
| XC8 100 mg and Placebo (Group B) | Experimental | XC8 100 mg orally.
1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period Receives: Drug: XC8 100 mg |
| XC8 200 mg and Placebo (Group C) | Experimental | XC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period. Receives: Drug: XC8 200 mg |
| Placebo (Group D) | Placebo comparator | Placebo orally. Receives: Drug: XC8 20 mg; Drug: XC8 100 mg; Drug: XC8 200 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained improvement in clinical symptoms
Severity Rating Scale for ARVI (<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (<37°C) (estimated by Kaplan-Meier), established according to patient diaries.
Measured: up to Day 5
Secondary outcomes (1)
Body temperature below 37°C without further elevation
Time to normalization of body temperature since the symptoms onset, measured in hours
Measured: up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start3 Feb 2016
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441373
- Sponsor's protocol ID
- FLU-XC8-01
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 23 Feb 2018
- 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)
- ClinicalTrials.gov ID
- NCT03441373
- Acronym / sponsor ID
- FLU-XC8-01
- Conditions
- Influenza, Acute Respiratory Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 22 Feb 2018 (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.
A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment.
The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.
Detailed description
Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up.
In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio:
Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients).
Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control.
In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio:
Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients).
During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XC8 20 mg and Placebo (Group A) | Experimental | Drug: XC8 20 mgXC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period |
| XC8 100 mg and Placebo (Group B) | Experimental | Drug: XC8 100 mgXC8 100 mg orally. 1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period |
| XC8 200 mg and Placebo (Group C) | Experimental | Drug: XC8 200 mgXC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period. |
| Placebo (Group D) | Placebo comparator | Drug: XC8 20 mg, Drug: XC8 100 mg, Drug: XC8 200 mg, Drug: PlaceboPlacebo orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women aged 18 to 45 years (inclusively).
- Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.
- Uncomplicated course of ARVI or influenza.
- The onset of symptoms no more than 36h prior to the inclusion into the study.
- Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
Key exclusion criteria (22 listed)
- The patient will be deemed ineligible for the study meeting any of the following criteria:
- Complicated course of influenza or ARVI (including the presence / development of bacterial infection).
- Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
- Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
- Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
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 |
|---|---|---|
| XC8 20 mgAlso: Нistamine glutarimideonce daily during 5 days. | Drug | Placebo (Group D), XC8 20 mg and Placebo (Group A) |
| XC8 100 mgAlso: Нistamine glutarimideonce daily during 5 days. | Drug | Placebo (Group D), XC8 100 mg and Placebo (Group B) |
| XC8 200 mgAlso: Нistamine glutarimideonce daily during 5 days. | Drug | Placebo (Group D), XC8 200 mg and Placebo (Group C) |
| Placeboonce daily during 5 days. | Drug | Placebo (Group D) |
Primary outcome
Time to sustained improvement in clinical symptoms
Time frame: up to Day 5
Severity Rating Scale for ARVI (<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (<37°C) (estimated by Kaplan-Meier), established according to patient diaries.
1 secondary outcome
Body temperature below 37°C without further elevation
Time frame: up to Day 8
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 23 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing XC8 20 mg, XC8 100 mg and XC8 200 mg in people with Influenza and Acute Respiratory Infection, run by PHARMENTERPRISES LLC at 18 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 22 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to sustained improvement in clinical symptoms (time frame: up to Day 5). 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 23 Feb 2018.