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

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ClinicalTrials.gov Identifier: NCT03455491
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
PHARMENTERPRISES LLC

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Viral Infections Influenza Drug: XC221 100 mg Drug: XC221 200 mg Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Blinding will carried out by using Placebo equivalent to XC221 tablets without active substance and the corresponding labeling of the study drug.
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A

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
once daily during 3 days.
Experimental: Group B
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Drug: XC221 200 mg
once daily during 3 days.
Placebo Comparator: Group C
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Drug: Placebo
once daily during 3 days.



Primary Outcome Measures :
  1. 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 ]
    Measured in hours Severity Rating Scale for ARVI


Secondary Outcome Measures :
  1. Body temperature below 37°C without further elevation [ Time Frame: From the time of randomization until the time of body temperature below 37°C, assessed up to Day 14 ]
    Time to normalization of body temperature, measured in hours

  2. Percentage of patients with complications of ARVI or Influenza [ Time Frame: From the time of randomization up to Day 14 ]
    Existence of complications of ARVI or Influenza will be estimated, including secondary complications



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455491


Locations
Russian Federation
City Clinical Hospital №9 Recruiting
Izhevsk, Russian Federation, 426063
Contact: Andrey V. Ejov    +7 (912) 465 6758    andigel2@rambler.ru   
Kuban State Medical University Recruiting
Krasnodar, Russian Federation, 350063
Contact: Marina G. Avdeeva, Prof    +7 918 441 26 06    AvdeevaM@mail.ru   
City Clinical Hospital №1 n.a. Semashko Recruiting
Rostov-on-Don, Russian Federation, 344000
Contact: Natalia Y. Pshenichnaya, Prof    +7 918 553 53 06    natalia-pshenichnaya@yandex.ru   
Ryazan State Medical University n.a. Pavlov Recruiting
Ryazan', Russian Federation, 390026
Contact: Vladimir A. Martynov, MD,PhD    +7 (910) 643 3271    dr.martinov@mail.ru   
The Center for Prevention and Fight about AIDS and Infectious Diseases Recruiting
Saint Petersburg, Russian Federation, 190103
Contact: Natalya V. Dunaeva, Doctor of MS    +7 (921) 741 8820    nvch@mail.ru   
The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation Recruiting
Saint Petersburg, Russian Federation, 197110
Contact: Natalia N. Burova, Doctor of MS    +7 (921) 637 95 61    nnburova@rambler.ru   
Research Institute of Influenza Recruiting
Saint Petersburg, Russian Federation, 197376
Contact: Julia V. Drozdova, MD    +7 (921) 942 0870    Drozdova-julia78@mail.ru   
City Clinical Hospital №40 of Kurortny District Recruiting
Saint Petersburg, Russian Federation, 197706
Contact: Alina S. Agafina, PhD    +7 921) 583 7808    a.agafina@mail.ru   
Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital Recruiting
Saransk, Russian Federation, 430024
Contact: Vera F. Pavelkina, Prof    +7 (906) 379 5641    pavelkina@rambler.ru   
Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1 Recruiting
Volgograd, Russian Federation, 400131
Contact: Mihail E. Statsenko, Prof    +7 (927) 501 9583    mestatsenko@rambler.ru   
Сlinical Hospital №3 Recruiting
Yaroslavl, Russian Federation, 150007
Contact: Sergey M. Noskov, Prof.    +7 (961) 972 2962    noskov03@gmail.ru   
Sponsors and Collaborators
PHARMENTERPRISES LLC

Responsible Party: PHARMENTERPRISES LLC
ClinicalTrials.gov Identifier: NCT03455491     History of Changes
Other Study ID Numbers: ARI-XC221-02
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases