Phase 3
N=240
Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection
Viral Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT04244084 ↗Enrolled (actual)
240
Serious AEs
0.4%
Results posted
Oct 2021
Primary outcome: Primary: Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms — 4.1; 5.0 days — p=0.0155
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MMH-407 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Materia Medica Holding
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms |
4.1; 5.0 | 0.0155 sig |
| SECONDARY Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed) |
48.5; 52.6 | 0.1839 |
| SECONDARY Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed) |
15; 8; 44; 38; 74; 70 | 0.0640 |
| SECONDARY Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed) |
4.4; 4.8 | 0.1927 |
| SECONDARY Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed) |
12; 3; 28; 22; 54; 38 | 0.0014 sig |
| SECONDARY Dosing Frequency of Antipyretics. |
0.30; 0.38; 0.19; 0.24; 0.03; 0.04 | 0.2009 |
| SECONDARY Percentage of Patients Reporting Worsening of Illness |
1; 3 | 0.62 |
| SECONDARY Occurrence and Characteristics of Adverse Events (AEs) |
9; 11; 9; 11; 8; 11 | — |
| SECONDARY Changes in Vital Signs: Blood Pressure. |
121.0; 121.0; 120.0; 120.0; 120.0; 119.0 | 0.5981 |
| SECONDARY Changes in Vital Signs: Pulse Rate (Heart Rate). |
86.9; 88.0; 73.5; 74.4; 71.1; 71.7 | 0.4426 |
| SECONDARY Changes in Vital Signs: Respiration Rate (Breathing Rate). |
17.4; 17.5; 16.6; 16.7; 16.4; 16.4 | 0.6197 |
| SECONDARY Percentage of Patients With Clinically Relevant Laboratory Abnormalities |
0; 1 | 1.000 |
Summary
To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).
Eligibility Criteria
Inclusion Criteria
- Patients of either gender aged 18-70 years.
- 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.
- The first 24 hours after ARVI onset.
- Patients giving their consent to use reliable contraception during the study.
- Signed patient information sheet (informed consent form).
Exclusion Criteria
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
- 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).
- Patients requiring antiviral medication prohibited within the study.
- Medical history of primary and secondary immunodeficiency.
- Medical history/suspicion of oncology of any localization (except for benign neoplasms).
- Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Allergy/ hypersensitivity to any component of the study drug.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
- 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.
- Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.
- Participation in other clinical trials for 3 months prior to enrollment in this study.
- 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).
- 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).
Data sourced from ClinicalTrials.gov (NCT04244084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.