Clinical trial NCT03455491: Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Viral Infections
Influenza
Lead sponsor: PHARMENTERPRISES LLC
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
timeFrame: From the time of randomization up to Day 14
Secondary outcomes:
measure: Time to Body Temperature Normalization
timeFrame: From the time of randomization assessed up to Day 14
measure: Percentage of Patients With Complications
timeFrame: From the time of randomization up to Day 14
measure: The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
timeFrame: From randomization up to 3 days of treatment
Other outcomes:
Locations:
city: Izhevsk
country: Russian Federation
facility: City Clinical Hospital №9
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Rostov-on-Don
country: Russian Federation
facility: City Clinical Hospital №1 n.a. Semashko
city: Ryazan'
country: Russian Federation
facility: Ryazan State Medical University n.a. Pavlov
city: Saint Petersburg
country: Russian Federation
facility: The Center for Prevention and Fight about AIDS and Infectious Diseases
city: Saint Petersburg
country: Russian Federation
facility: The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Influenza
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Hospital №40 of Kurortny District
city: Saransk
country: Russian Federation
facility: Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
city: Yaroslavl
country: Russian Federation
facility: Сlinical Hospital №3
Study officials:
References: