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CompletedNCT03455491Updated Nov 4, 2019Results posted

Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

A Phase 2 interventional study of XC221 100 mg and XC221 200 mg in Acute Respiratory Viral Infections and Influenza, sponsored by PHARMENTERPRISES LLC. Completed at 11 sites in Russian Federation. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by PHARMENTERPRISES LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Acute Respiratory Viral Infections
  • Influenza
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men and women aged 18 to 45 years (inclusively).
  2. Clinically diagnosed influenza or ARVI.
  3. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
  4. Uncomplicated course of influenza or ARVI based on clinical estimations.
  5. The first 36 hours from the beginning of symptoms of influenza or ARVI.
  6. 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.
  7. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
  8. Signed Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  1. Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
  2. Hypersensitivity to excipients of the drug XC221 or placebo.
  3. 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.
  4. 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).
  5. 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).
  6. Infectious diseases during the last week before including into the study.
  7. History of bronchial asthma.
  8. History of increased convulsive activity.
  9. 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).
  10. History of oncological diseases, HIV, tuberculosis.
  11. Diabetes mellitus.
  12. Drug or alcohol abuse.
  13. Participation in any other clinical trial in the last 90 days.
  14. Pregnancy or lactation.
  15. Military or prison populations.
  16. Impossibility or inability to comply with the study procedures.
  17. A member of the investigator's family or other person interested in the results of the study.
  18. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
  19. History of renal insufficiency.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    XC221 100 mg

    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

    Drug: XC221 100 mg

  • Experimental
    XC221 200 mg

    XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period

    Drug: XC221 200 mg

  • Placebo comparator
    Placebo

    Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period

    Drug: Placebo

Interventions

  • DrugXC221 100 mg

    once daily during 3 days.

  • DrugXC221 200 mg

    once daily during 3 days.

  • DrugPlacebo

    once daily during 3 days.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the time of randomization up to Day 14

Secondary outcomes

  1. 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)

    Time frame: From the time of randomization assessed up to Day 14

  2. Percentage of Patients With Complications

    The percentage of patients with complications of influenza/acute viral URI

    Time frame: From the time of randomization up to Day 14

  3. 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.

    Time frame: From randomization up to 3 days of treatment

06

Results

Posted Nov 4, 2019

Participant flow

Patients receiving both in- and outpatient treatment could be enrolled.

Participant flow — Overall Study
MilestoneGroup AGroup BGroup C
Started404040
Completed404040
Not completed000

Outcome measures

PrimaryTime 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.

Time frame:
From the time of randomization up to Day 14
Reported as:
Median · hours
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
hoursXC221 100 mgXC221 200 mgPlacebo
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI57.38 (53.31 to 73.53)67.75 (53.69 to 73.87)69.64 (63.56 to 88.97)
Statistical analysis
  • XC221 100 mg vs XC221 200 mg vs Placebo · Gekhan-Wilcoxon test · p = 0.3541
SecondaryTime 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)

Time frame:
From the time of randomization assessed up to Day 14
Reported as:
Mean · hours
Time to Body Temperature Normalization
hoursXC221 100 mgXC221 200 mgPlacebo
Time to Body Temperature Normalization61.08 ± 52.8552.26 ± 34.0861.40 ± 38.06
Statistical analysis
  • XC221 100 mg vs XC221 200 mg vs Placebo · Gekhan-Wilcoxon test · p = 0.3597
SecondaryPercentage of Patients With Complications

The percentage of patients with complications of influenza/acute viral URI

Time frame:
From the time of randomization up to Day 14
Reported as:
Count of participants · Participants
Percentage of Patients With Complications
ParticipantsXC221 100 mgXC221 200 mgPlacebo
No complications394040
With complications100
SecondaryThe 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.

Time frame:
From randomization up to 3 days of treatment
Reported as:
Mean · Ln(units_on_a_scale*sec)
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
Ln(units_on_a_scale*sec)XC221 100 mgXC221 200 mgPlacebo
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy14.6 ± 0.414.6 ± 0.414.7 ± 0.4
Statistical analysis
  • XC221 100 mg vs XC221 200 mg vs Placebo · ANOVA · p = 0.4551one-way ANOVA

Adverse events

Collected over 16 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A0/40 (0%)0/40 (0%)16/40 (40%)
Group B0/40 (0%)0/40 (0%)13/40 (32.5%)
Group C0/40 (0%)0/40 (0%)14/40 (35%)
Most frequent other events
Showing 10 of 31
Most frequent other events
EventGroup AGroup BGroup C
Strengthening rhinorrheaEar and labyrinth disorders3/402/405/40
Strengthening ailmentsGeneral disorders5/401/403/40
HeadacheNervous system disorders2/402/404/40
Fever increaseGeneral disorders4/403/402/40
Increased nasal congestionEar and labyrinth disorders2/402/403/40
FeverGeneral disorders3/402/402/40
Strengthening coughRespiratory, thoracic and mediastinal disorders0/402/400/40
RhinorrheaEar and labyrinth disorders1/402/401/40
TickeringEar and labyrinth disorders0/400/402/40
Increased sneezingEar and labyrinth disorders2/400/401/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group AGroup BGroup CTotal
Mean30 ± 7.331.1 ± 7.132.2 ± 8.131.1 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)Group AGroup BGroup CTotal
Female25242372
Male15161748
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group AGroup BGroup CTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White403940119
More than one race0000
Unknown or Not Reported0101
Region of Enrollment
Region of Enrollment(participants)Group AGroup BGroup CTotal
Russia404040120
Presence of confirmed viral infection by PCR
Presence of confirmed viral infection by PCR(Participants)Group AGroup BGroup CTotal
Viral infection confirmed by PCR29272278
No viral infection confirmed by PCR11131842
07

Study locations

11 sites
  • City Clinical Hospital №9
    Izhevsk, 426063, Russian Federation
  • Kuban State Medical University
    Krasnodar, 350063, Russian Federation
  • City Clinical Hospital №1 n.a. Semashko
    Rostov-on-Don, 344000, Russian Federation
  • Ryazan State Medical University n.a. Pavlov
    Ryazan', 390026, Russian Federation
  • The Center for Prevention and Fight about AIDS and Infectious Diseases
    Saint Petersburg, 190103, Russian Federation
  • The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
    Saint Petersburg, 197110, Russian Federation
  • Research Institute of Influenza
    Saint Petersburg, 197376, Russian Federation
  • City Clinical Hospital №40 of Kurortny District
    Saint Petersburg, 197706, Russian Federation
  • Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
    Saransk, 430024, Russian Federation
  • Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
    Volgograd, 400131, Russian Federation
  • Сlinical Hospital №3
    Yaroslavl, 150007, Russian Federation
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 25, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03455491
Lead sponsor
PHARMENTERPRISES LLC
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Feb 12, 2018
Primary completion
Jun 28, 2018
Completion
Jun 28, 2018
Results posted
Nov 4, 2019
Last update
Nov 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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