Status:
COMPLETED
XC8 in the Treatment of Patients With Acute Respiratory Viral Infection
Lead Sponsor:
PHARMENTERPRISES LLC
Conditions:
Influenza
Acute Respiratory Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placeb...
Detailed Description
Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase II...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 45 years (inclusively).
- Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.
- Uncomplicated course of ARVI or influenza.
- The onset of symptoms no more than 36h prior to the inclusion into the study.
- 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 Informant Consent Form.
Exclusion
- The patient will be deemed ineligible for the study meeting any of the following criteria:
- Complicated course of influenza or ARVI (including the presence / development of bacterial infection).
- 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.
- 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.
- Hypersensitivity to excipients of the XC8.
- Diabetes mellitus, lactose intolerance, lactase deficiency.
- 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.
- Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01.
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Key Trial Info
Start Date :
February 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2017
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03441373
Start Date
February 3 2016
End Date
February 9 2017
Last Update
February 23 2018
Active Locations (18)
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1
Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
Izhevsk, Russia, 426063
2
State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
Kazan', Russia, 420012
3
State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Krasnodar, Russia, 350063
4
Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
Nizhny Novgorod, Russia, 603022