Status:
COMPLETED
Study to Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI
Lead Sponsor:
PHARMENTERPRISES LLC
Collaborating Sponsors:
RSV Therapeutics LLC
Conditions:
Influenza
Acute Respiratory Viral Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The innovative drug XC221 is planned for use in treatment of acute respiratory viral infections in a double-blind, randomized, placebo-controlled, comparative multicenter study assessing the safety, t...
Detailed Description
A double-blind, randomized, placebo-controlled, comparative multicenter study in two groups. A total of 120 patients with uncomplicated influenza or other acute respiratory viral infections are planne...
Eligibility Criteria
Inclusion
- Both sexes aged 18 years and older.
- Clinically diagnosed influenza or ARVI mild or moderate severity.
- 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.
Exclusion
- Complications of influenza or ARVI (including the presence / development of bacterial infection).
- The need for inpatient treatment of influenza and ARVI.
- Hypersensitivity to excipients of the drug XC221 or placebo.
- Antiviral medications 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 of viral pneumonia symptoms (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.
- Bronchial asthma, COPD, pulmonary emphysema in history.
- 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.
- Drug or alcohol abuse.
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- 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.
- Deviations from laboratory standards, which prevent the inclusion of the patient in the study according to the Investigator.
- A history of kidney failure.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03830905
Start Date
January 31 2019
End Date
July 3 2019
Last Update
November 16 2020
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Federal State Budgetary Institution of Health "Northern Medical Clinical Center named after NA Semashko of the Federal Medical and Biological Agency"
Arkhangelsk, Russia, 163000
2
Regional State Budgetary Institution of Health "Belgorod Regional Clinical Hospital of St. Joasaph"
Belgorod, Russia, 308007
3
City Clinical Hospital №9
Izhevsk, Russia, 426063
4
Kuban State Medical University
Krasnodar, Russia, 350063