Clinical Trial of Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults
キーワード
概要
説明
Design: a multicenter, placebo-controlled, double-blind, randomized clinical trial in parallel groups.
The study will include both male and female patients aged 18-64 years with clinical signs of influenza within the first 24 hours of the onset of illness.
The influenza diagnosis must be supported by a positive rapid test (detection of influenza virus antigens in nasal epithelial cells). After the patients provide signed Participant Information Sheet and Informed Consent form, their medical history and body temperature will be recorded and physical examination and rapid diagnostic test performed. Patients who test positive will be assessed for 7 influenza-associated symptoms: cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, fatigue.
4-point Flu Symptom Severity scale will be used: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom.
Nasopharyngeal swabs will be obtained from these patients for subsequent real-time reverse transcription polymerase chain reaction (RT-PCR) influenza A/B testing and laboratory tests performed.
If a patient meets all inclusion criteria and does not meet any of the exclusion criteria at Visit 1 (Day 1), he/she will be randomized into one of the treatment groups: Group 1: ММН-407 for 5 days, or Group 2: Placebo on the ММН-407 regimen for 5 days.
The patients will use electronic patient diaries to daily record their morning and evening axillary temperature (taken using a Geratherm mercury-free thermometer) and severity of 7 influenza-associated symptoms (using the Flu Symptom Severity scale). In addition to this, the patients will record doses of antipyretic drugs taken (when applicable) and any worsening of their health status (when applicable, to assess treatment safety and collect adverse events data).
In total, patients will be observed for 14 days (screening and randomization − up to 24 hours, treatment − 5 days, subsequent observation − up to 2 days; and a follow-up 'telephone' visit − Day 14).
During the study, 3 visits from patient to the physician's office and a follow-up telephone visit will be accomplished: 1) patient visits − Days 1, 3 and 7 (Visits 1, 2, and 3) at the medical centre; 2) telephone visit from the physician (Visit 4) - Day 14.
During Visits 2 and 3, the physician will perform a physical examination, record the changes in patients' symptoms and the use of concomitant medications and check the completion of patient diaries. At Visit 2, nasopharyngeal swabs for RT-PCR will be collected. Visit 3 will involve an assessment of treatment compliance and laboratory tests. The telephone visit is intended to provide information on a patient's health status, presence/absence of secondary bacterial complications and the use of antibiotics.
During the study, subjects will be allowed to use symptomatic therapy and medications for their co-morbidities, except for the medicines listed in the "Prohibited Concomitant Medications" section.
日付
| 最終確認済み: | 11/30/2019 |
| 最初に提出された: | 01/28/2020 |
| 提出された推定登録数: | 01/28/2020 |
| 最初の投稿: | 01/30/2020 |
| 最終更新が送信されました: | 02/06/2020 |
| 最終更新日: | 02/09/2020 |
| 実際の研究開始日: | 12/11/2019 |
| 一次完了予定日: | 11/30/2022 |
| 研究完了予定日: | 11/30/2022 |
状態または病気
介入/治療
Drug: MMH-407
Drug: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: MMH-407 Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. | Drug: MMH-407 MMH-407: For oral use. |
| Placebo Comparator: Placebo Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. | Drug: Placebo Placebo: For oral use. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Patients of male and female gender aged 18 to 64 years. 2. Uncomplicated, moderate influenza supported by all the symptoms: - axillary temperature ≥38.1°С on physician examination; - at least one moderate general symptom of influenza infection (headache, fever/chill, aches in the muscles/joints, weakness/drowsiness); - at least one moderate respiratory symptom of influenza infection (cough, sore throat, or nasal congestion). 3. Positive influenza rapid test (detection of virus antigens in the nasal epithelium). 4. First 24 hours of the onset of illness. 5. Patients who agree to use a reliable method of birth control during the study. 6. Patients who have provided signed Participant Information Sheet and Informed Consent form to participate in a clinical trial. Exclusion Criteria: 1. Severe influenza infection that requires hospitalization. 2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) that requires the use of antibiotics, starting from the first day of illness. 3. Suspected early manifestations of a condition that, on its first onset, produces symptoms similar to those of influenza (other infectious diseases and/or influenza-like syndrome associated with the first onset of a systemic connective tissue disorder or another condition). 4. Patients who require the use of antivirals that are not permitted during the study. 5. Current season influenza vaccination. 6. Prior history or diagnosis of primary or secondary immunodeficiency 7. Patients with any known or suspected malignant neoplasm. 8. An exacerbated or decompensated chronic disease interfering with the subject's participation in the clinical trial. 9. Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency), and/or galactosemia. 10. Current allergy to or intolerance of the active substances or any of the excipients in the medications used in the treatment. 11. Pregnancy, breast-feeding, childbirth within less than 3 months prior to the inclusion in the trial, or unwillingness to use contraceptive methods during the study 12. Prior history of non-adherence to medication; mental disorder; or alcohol or substance abuse, which, in the investigator's opinion, will compromise compliance with study procedures. 13. Use of any of the "Prohibited Concomitant Medications" within 2 weeks prior to study entry. 14. Patients who, as judged by the investigator, will fail or be unwilling to comply with the observation requirements or adhere to the dosing regimen during the study. 15. Participation in other clinical studies within 3 months prior to the inclusion in this study. 16. Patients who are related to any of the on-site research personnel directly involved in the conduct of the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). 17. Patients who work for OOO "NPF "Materia Medica Holding" (i.e. company employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned). |
結果
主な結果の測定
1. Time to improvement of influenza symptoms. [On days 1-14 of observation.]
二次的な結果の測定
1. Proportion of patients reporting improvement of influenza symptoms. [On days 1-14 of observation period.]
2. Severity of illness. [On days 1- 6 of the observation period.]
3. Proportion of patients with negative virus shedding. [On day 3 of the observation period.]
4. Dosing frequency of antipyretics according to indications. [On days 1-3 of the treatment period.]
5. Proportion of subjects reporting worsening of illness. [On days 4 -14 of the observation period.]
6. Occurrence and nature of adverse events (AE). [On days 1-5 of the treatment period.]
7. Number of patients with treatment-related changes in vital signs: body temperature, pulse rate (heart rate), respiration rate (breathing rate), and blood pressure. [On days 1- 5 of the treatment period.]
8. Proportion of subjects with clinically significant abnormal laboratory data. [On days 1- 5 of the treatment period.]
