InfluenzaPhase 2NCT03830905
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
A Phase 2 study testing XC221 in people with Influenza and Acute Respiratory Viral Infections, run by PHARMENTERPRISES LLC at 16 sites in Russia.
Trial summary
The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Acute Respiratory Viral Infections
- What is being tested?
- XC221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 16 sitesRussia
- Study dates
- 31 Jan 2019to 3 Jul 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes aged 18 years and older.
- Clinically diagnosed influenza or ARVI mild or moderate severity.
- Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
- Uncomplicated course of influenza or ARVI based on clinical estimations.
- The first 36 hours from the beginning of symptoms of influenza or ARVI.
- 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 Informed Consent Form.
Who cannot join
- Complications of influenza or ARVI (including the presence / development of bacterial infection).
- The need for inpatient treatment of influenza and ARVI.
- Hypersensitivity to excipients of the drug XC221 or placebo.
- Antiviral medications 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 of viral pneumonia symptoms (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).
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- Infectious diseases during the last week before including into the study.
- Bronchial asthma, COPD, pulmonary emphysema in history.
- 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.
- Drug or alcohol abuse.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- 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.
- Deviations from laboratory standards, which prevent the inclusion of the patient in the study according to the Investigator.
- A history of kidney failure.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Russia16 sites
Federal State Budgetary Institution of Health "Northern Medical Clinical Center named after NA Semashko of the Federal Medical and Biological Agency"
Arkhangelsk, 163000
Regional State Budgetary Institution of Health "Belgorod Regional Clinical Hospital of St. Joasaph"
Belgorod, 308007
City Clinical Hospital №9
Izhevsk, 426063
Kuban State Medical University
Krasnodar, 350063
State budget institution of health care of the Moscow region "Krasnogorsk city hospital number 1"
Krasnogorsk, 143408
Non-governmental Healthcare Institution "N.A.Semashko Road Clinical Hospital at the Lyublino station of the open joint-stock company "Russian Railways"
Moscow, 109386
Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
Ryazan, 390026
Ryazan State Medical University n.a. Pavlov
Ryazan, 390026
The Center for Prevention and Fight about AIDS and Infectious Diseases
Saint Petersburg, 190103
LLC "Aurora Medi"
Saint Petersburg, 193232
The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
Saint Petersburg, 197110
Research Institute of Influenza
Saint Petersburg, 197376
City Clinical Hospital №40 of Kurortny District
Saint Petersburg, 197706
LLC "Astarta"
Saint Petersburg, 199226
Federal State Budgetary Educational Institution of Higher Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation
Yaroslavl, 150000
State Budgetary Healthcare Institution (SBHI) of Yaroslavl region
Yaroslavl, 150007
About this study
Official title: Double-blind Randomized Placebo-controlled Comparative Multicenter Study to Assess the Safety, Tolerability and Efficacy of XC221 in a Dose of 200mg Per Day in Patients With Uncomplicated Influenza or Other ARVI
The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute respiratory viral infections during the 3-days treatment.
Read the detailed description
A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planned to be randomized. Patients will be randomized into 2 groups: 60 patients in the treatment group 200 mg XC221 and 60 patients in the placebo group. The purpose of the clinical trial is to assess the safety, tolerability and efficacy of the drug XC21 in treatment of influenza or other acute respiratory viral infections. The primary objective is to demonstrate the difference between the groups in the time of the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale. The study will consist of the following periods: screening (duration not more than 36 hours from the moment of the first symptoms of the disease), treatment period (3 days), follow-up period (11 ± 1 days after completion of treatment with the study drug/placebo). The duration of participation in the study for each patient is no more than 16 days and 12 hours.
- Conditions
- Influenza, Acute Respiratory Viral Infections
- Being tested
- XC221, 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.
XC221Drug
Participants will receive 200 mg XC221 once a day during 3 days
PlaceboDrug
Participants will receive Placebo once a day during 3 days
| Study group | Role | What they receive |
|---|---|---|
| XC221 | Experimental | XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period Receives: Drug: XC221 |
| Placebo | Placebo comparator | Placebo orally. 2 tablets of Placebo once daily during 3 days of treatment period Receives: 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 according to the Modified Jackson Scale for measuring respiratory symptoms.
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug.
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
Secondary outcomes (11)
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).
The time of the first assessment of 3 consecutive ratings on the Modified Jackson Scale, in which all the clinical symptoms were 0 points.
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Total score of no more than 3 points, when there is no more than 1 point for each symptom, measured in hours from the moment of taking the first dose of the drug.
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
Time to normalization of body temperature.
Measured in hours. Normalization means the establishment of body temperature below 37° C without a rise above these values in the subsequent observation period.
Measured: From the moment of the first dose up to Day 14
The average score according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
The average score according to the Modified Jackson Scale on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
The proportion of patients with a sum of not more than 3 points according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days
Score for each symptom should be no higher than 1 point at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days from the moment of the start of treatment.
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
The proportion of patients with the normalization of body temperature on the first - the 14th days from the start of treatment;
Measured: From the moment of the first dose up to Day 14
Time to disappearance (0 points) of each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Symptom (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) manifested at the level of 2 or 3 points at the first assessment at Visit 0 (Day 0).
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
The proportion of patients with 0 points score for each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Modified Jackson Scale (sneezing, rhinorrhea, nasal congestion, cough, fever, malaise, chills, headache, myalgia, sore throat, tickling, hoarseness) at the 2nd, 3rd 2nd, 4th, 5th, 6th, 7th and 8th days from the moment of the start of treatment in a population of patients with the corresponding symptom shown at the level of 2 or 3 points at Visit 0 (Day 0).
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Measured: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen
The proportion of patients with a detected viral pathogen at Visit 0, Visit 4 and Visit 6.
Measured: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen at Visit 4 and Visit 6 compared with the initial proportion of such patients in the XC221.
Measured: From the moment of the first dose up to Day 14
The frequency of adverse events (AEs) and serious adverse events (SAEs) in the XC221 treatment group and in the placebo group.
Measured: From the moment of the first dose up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start31 Jan 2019
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMENTERPRISES LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RSV Therapeutics LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830905
- Sponsor's protocol ID
- ARI-XC221-03
- Status last verified
- Nov 2020
- First submitted
- 30 Jan 2019
- Last updated
- 16 Nov 2020
- 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 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Placebo-controlled Comparative Multicenter Study to Assess the Safety, Tolerability and Efficacy of XC221 in a Dose of 200mg Per Day in Patients With Uncomplicated Influenza or Other ARVI
- ClinicalTrials.gov ID
- NCT03830905
- Acronym / sponsor ID
- ARI-XC221-03
- Conditions
- Influenza, Acute Respiratory Viral Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Collaborators
- RSV Therapeutics LLC
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 5 Feb 2019 (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 innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, tolerability and efficacy of XC221 at a dose of 200 mg per day in patients with uncomplicated influenza or other acute respiratory viral infections during the 3-days treatment.
Detailed description
A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planned to be randomized. Patients will be randomized into 2 groups: 60 patients in the treatment group 200 mg XC221 and 60 patients in the placebo group. The purpose of the clinical trial is to assess the safety, tolerability and efficacy of the drug XC21 in treatment of influenza or other acute respiratory viral infections. The primary objective is to demonstrate the difference between the groups in the time of the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale. The study will consist of the following periods: screening (duration not more than 36 hours from the moment of the first symptoms of the disease), treatment period (3 days), follow-up period (11 ± 1 days after completion of treatment with the study drug/placebo). The duration of participation in the study for each patient is no more than 16 days and 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XC221 | Experimental | Drug: XC221XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally. 2 tablets of Placebo once daily during 3 days of treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both sexes aged 18 years and older.
- Clinically diagnosed influenza or ARVI mild or moderate severity.
- Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
- Uncomplicated course of influenza or ARVI based on clinical estimations.
- The first 36 hours from the beginning of symptoms of influenza or ARVI.
Key exclusion criteria (20 listed)
- Complications of influenza or ARVI (including the presence / development of bacterial infection).
- The need for inpatient treatment of influenza and ARVI.
- Hypersensitivity to excipients of the drug XC221 or placebo.
- Antiviral medications 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).
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 |
|---|---|---|
| XC221Participants will receive 200 mg XC221 once a day during 3 days | Drug | XC221 |
| PlaceboParticipants will receive Placebo once a day during 3 days | Drug | Placebo |
Primary outcome
Time to sustained improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Time frame: From the moment of the first dose up to Day 14
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
11 secondary outcomes
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms (0 points).
Time frame: From the moment of the first dose up to Day 14
The time before the onset of persistent improvement in clinical symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Time frame: From the moment of the first dose up to Day 14
Time to normalization of body temperature.
Time frame: From the moment of the first dose up to Day 14
The average score according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th days.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a sum of not more than 3 points according to the Modified Jackson Scale for measuring respiratory symptoms at the 1st, 2nd, 3rd, 4th, 5th, 6th , The 7th, 8th days
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with the normalization of body temperature on the first - the 14th days from the start of treatment;
Time frame: From the moment of the first dose up to Day 14
Time to disappearance (0 points) of each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with 0 points score for each of the symptoms according to the Modified Jackson Scale for measuring respiratory symptoms.
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen
Time frame: From the moment of the first dose up to Day 14
The proportion of patients with a detected viral pathogen at Visit 4 and Visit 6 compared with the initial proportion of such patients in the XC221.
Time frame: From the moment of the first dose up to Day 14
The frequency of adverse events (AEs) and serious adverse events (SAEs) in the XC221 treatment group and in the placebo group.
Time frame: From the moment of the first dose up to Day 14
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 Nov 2020.
- 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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XC221 in people with Influenza and Acute Respiratory Viral Infections, run by PHARMENTERPRISES LLC at 16 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 8 inclusion and 20 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 according to the Modified Jackson Scale for measuring respiratory symptoms. (time frame: From the moment of the first dose up to Day 14). 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 Nov 2020.