Clinical trial NCT04244084: Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection
Official title: Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of MMH-407 in the Treatment of Acute Respiratory Viral Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Viral Respiratory Infection
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2020-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).

Detailed description: Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial.

The study will enroll outpatients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease during seasonal ARVI morbidity.

After signing patient information sheet and informed consent form, medical history, thermometry, objective examination, laboratory tests and concomitant medication will be performed. Severity of ARVI symptoms is evaluated with 4-point scale.

The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.

If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1) he/she will be randomized into one of two groups: the 1st group will take MMH-407 according to the dosage regimen for 5 days; the 2nd group will take Placebo according to MMH-407 dosage regimen for 5 days.

The study will use electronic patient diary for recording morning and evening axillary body temperature (measured using a mercury-free Geratherm Classic thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any aggravation in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be recorded in a patient diary. The investigator will provide instructions on filling the diary; at Visit 1 the patient together with a doctor will record ARVI symptom severity and body temperature in the diary.

Patient will be observed for 14 days (screening, randomization - Day 1, treatment period - 5 days, follow-up - up to 2 days; deferred "phone visit" - Day 14).

During the treatment and follow-up period the patients or investigators will make 3 visits and the fourth "phone visit" will be scheduled additionally: 1) visits by physician/patient - on Days 1, 5 and 7 (Visits 1, 2 and 3) - in a study center or at home; 2) "phone visit" (Visit 4) - on Day 14.

At Visits 2 and 3, the investigator will perform an objective examination, document changes in the symptoms and concomitant medications to check patient diaries. At Visit 3 compliance will be evaluated and laboratory tests will be performed. "Phone visit" is carried out to interview the patient about his/her condition, presence/absence of secondary bacterial/viral complications and use of antibiotics.

During the study, symptomatic therapy and therapy for their co-morbidities are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".

Eligibility criteria: Inclusion Criteria:

1. Patients of either gender aged 18-70 years.
2. Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.
3. The first 24 hours after ARVI onset.
4. Patients giving their consent to use reliable contraception during the study.
5. Signed patient information sheet (informed consent form).

Exclusion Criteria:

1. Clinical symptoms of severe influenza/ARVI requiring hospitalization.
2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
3. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
4. Patients requiring antiviral medication prohibited within the study.
5. Medical history of primary and secondary immunodeficiency.
6. Medical history/suspicion of oncology of any localization (except for benign neoplasms).
7. Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
9. Allergy/ hypersensitivity to any component of the study drug.
10. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
11. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
12. Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
13. Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.
14. Participation in other clinical trials for 3 months prior to enrollment in this study.
15. Patients who are related to any of the on-site research personnel directly involved in 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).
16. Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Primary outcomes:
measure: Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
timeFrame: 14 days of observation.
Secondary outcomes:
measure: Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)
timeFrame: On days 1- 6 of the observation.
measure: Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
timeFrame: On days 3, 4, 5 and 6 of observation.
measure: Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)
timeFrame: 14 days of observation.
measure: Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
timeFrame: On days 3, 4, 5 and 6 of observation.
measure: Dosing Frequency of Antipyretics.
timeFrame: On days 1, 2, 3 of therapy.
measure: Percentage of Patients Reporting Worsening of Illness
timeFrame: From day 4 to day 14 of the observation period.
measure: Occurrence and Characteristics of Adverse Events (AEs)
timeFrame: From day 1 to day 7 of the treatment period.
measure: Changes in Vital Signs: Blood Pressure.
timeFrame: On days 1, 5 and 7 of the treatment period.
measure: Changes in Vital Signs: Pulse Rate (Heart Rate).
timeFrame: On days 1, 5 and 7 of the treatment period.
measure: Changes in Vital Signs: Respiration Rate (Breathing Rate).
timeFrame: On days 1, 5 and 7 of the treatment period.
measure: Percentage of Patients With Clinically Relevant Laboratory Abnormalities
timeFrame: From day 1 to day 7 of the treatment period.
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Altai State Medical University, Department of Faculty Therapy with a course of immunology and allergology
city: Barnaul
country: Russian Federation
facility: City Hospital #5
city: Belgorod
country: Russian Federation
facility: Belgorod State National Research University, Hospital Therapy Department
city: Chelyabinsk
country: Russian Federation
facility: Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways
city: Izhevsk
country: Russian Federation
facility: City Clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
city: Kazan
country: Russian Federation
facility: Kazan State Medical University, Internal Medicine Department
city: Kazan
country: Russian Federation
facility: Kazan State Medical University, Professorial clinic
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyDepartment
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: Moscow State Medical and Dental University named after A.I. Evdokimov, Pulmonology Laboratory
city: Nizhniy Novgorod
country: Russian Federation
facility: Road Clinical Hospital at the station Nizhny Novgorod of JSC Russian Railways
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital #10 of the Kanavinsky District of Nizhny Novgorod
city: Podolsk
country: Russian Federation
facility: Podolsk City Clinical Hospital # 3
city: Rostov-on-Don
country: Russian Federation
facility: City Emergency Hospital Rostov-on-Don
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University named after academician I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
city: Saint Petersburg
country: Russian Federation
facility: Vvedensky City Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #25 of the Nevsky District
city: Saint Petersburg
country: Russian Federation
facility: Medical Center "Reavita Med SPb"
city: Saint Petersburg
country: Russian Federation
facility: Road Clinical Hospital of JSC Russian Railways
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #51
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #34
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #43
city: Samara
country: Russian Federation
facility: Samara City Hospital #4
city: Stavropol
country: Russian Federation
facility: Scientific Medical Center for General Therapy and Pharmacology
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University, Internal Medicine Department
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
Study officials:
References: