Acute Respiratory Viral InfectionsPhase 2NCT03455491
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
A Phase 2 study testing XC221 100 mg and XC221 200 mg in people with Acute Respiratory Viral Infections and Influenza, run by PHARMENTERPRISES LLC at 11 sites in Russia.
Trial summary
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Respiratory Viral Infections, Influenza
- What is being tested?
- XC221 100 mg and XC221 200 mg
- 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
- 11 sitesRussia
- Study dates
- 12 Feb 2018to 28 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 ARVI.
- 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
- Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
- Hypersensitivity to excipients of the drug XC221 or placebo.
- 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.
Show all 19Show fewer
- 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.
- Diabetes mellitus.
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
City Clinical Hospital №9
Izhevsk, 426063
Kuban State Medical University
Krasnodar, 350063
City Clinical Hospital №1 n.a. Semashko
Rostov-on-Don, 344000
Ryazan State Medical University n.a. Pavlov
Ryazan, 390026
The Center for Prevention and Fight about AIDS and Infectious Diseases
Saint Petersburg, 190103
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
Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
Saransk, 430024
Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
Volgograd, 400131
Сlinical Hospital №3
Yaroslavl, 150007
About this study
Official title: Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.
The primary objective of the study is to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
Read the detailed description
11 Russian centers were planned for participation in this study. The study consists of three periods: screening, treatment and follow-up.
All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:
Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group C - Placebo (40 patients).
During the treatment period (3 days), patients will receive XC221 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasts for 11 days.
- Conditions
- Acute Respiratory Viral Infections, Influenza
- Being tested
- XC221 100 mg, XC221 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.
XC221 100 mgDrug
once daily during 3 days.
XC221 200 mgDrug
once daily during 3 days.
PlaceboDrug
once daily during 3 days.
| Study group | Role | What they receive |
|---|---|---|
| XC221 100 mg | Experimental | XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period Receives: Drug: XC221 100 mg |
| XC221 200 mg | Experimental | XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period Receives: Drug: XC221 200 mg |
| Placebo | Placebo comparator | Placebo orally. 2 tablets of Placebo 100 mg 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 Based on Modified Jackson Scale for ARVI
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 time of randomization up to Day 14
Secondary outcomes (3)
Time to Body Temperature Normalization
Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)
Measured: From the time of randomization assessed up to Day 14
Percentage of Patients With Complications
The percentage of patients with complications of influenza/acute viral URI
Measured: From the time of randomization up to Day 14
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
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 randomization up to 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start12 Feb 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Viral InfectionsStudies 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455491
- Sponsor's protocol ID
- ARI-XC221-02
- Status last verified
- Oct 2019
- First submitted
- 28 Feb 2018
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults
- ClinicalTrials.gov ID
- NCT03455491
- Acronym / sponsor ID
- ARI-XC221-02
- Conditions
- Acute Respiratory Viral Infections, Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PHARMENTERPRISES LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Posted 4 Nov 2019
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-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.
The primary objective of the study is to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
Detailed description
11 Russian centers were planned for participation in this study. The study consists of three periods: screening, treatment and follow-up.
All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:
Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group C - Placebo (40 patients).
During the treatment period (3 days), patients will receive XC221 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasts for 11 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XC221 100 mg | Experimental | Drug: XC221 100 mgXC221 100 mg orally. 1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period |
| XC221 200 mg | Experimental | Drug: XC221 200 mgXC221 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 100 mg once daily during 3 days of treatment period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 18 to 45 years (inclusively).
- Clinically diagnosed influenza or ARVI.
- 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 (19 listed)
- Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
- Hypersensitivity to excipients of the drug XC221 or placebo.
- 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 |
|---|---|---|
| XC221 100 mgonce daily during 3 days. | Drug | XC221 100 mg |
| XC221 200 mgonce daily during 3 days. | Drug | XC221 200 mg |
| Placeboonce daily during 3 days. | Drug | Placebo |
Primary outcome
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
Time frame: From the time of randomization 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.
3 secondary outcomes
Time to Body Temperature Normalization
Time frame: From the time of randomization assessed up to Day 14
Percentage of Patients With Complications
Time frame: From the time of randomization up to Day 14
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
Time frame: From randomization up to 3 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
11 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 100 mg and XC221 200 mg in people with Acute Respiratory Viral Infections and Influenza, run by PHARMENTERPRISES LLC at 11 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 19 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Based on Modified Jackson Scale for ARVI (time frame: From the time of randomization 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 4 Nov 2019.