BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19

NCT04797936 | Completed Phase 4

• 1 other identifier: BERI_UA_IMU_2020_000003751
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

According to WHO (World Health Organisation) data, about 40% of patients with COVID-19 (Corona Virus SARS-CoV-2) have a mild course of the disease, namely, cases of mild course are of great danger from the point of view of the spread of infection, since the main source of infection is a sick person. The mild course of COVID-19 is characterized by a number of nonspecific symptoms: fever, cough, sore throat, nasal congestion, malaise, headache, muscle pain. Evidence has emerged of loss of smell as a symptom of COVID-19 infection. Anosmia/hyposmia in the absence of other respiratory diseases, such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis, are considered as a clinical marker of COVID-19 infection in a pandemic.For people with a mild course of the disease, WHO recommends providing home care, and the recommendations come down to observing a sanitary-hygienic regimen and taking antipyretics if necessary. Unfortunately, the treatment of patients with a mild course is still outside the interest of medical science. In its updated strategy to curb the spread of COVID-19, WHO states the need for diagnosis, effective isolation, and treatment of patients with mild to moderate severity of the clinical course of patients.Currently, there is experience with the use of the drug Imupret for the treatment of nasopharyngitis associated with other viral pathogens, in particular Epstein-Barr virus. It was shown that the use of a Phyto preparation helps to accelerate the regression of symptoms characteristic of nasopharyngitis, as well as accelerate the elimination of the virus from the body. Obviously, the proven activity of Imupret is important in relation to the activation of factors of nonspecific immunity, which is important in confronting viruses, including COVID-19. Another obvious factor that is important for the treatment of viral diseases is the synergism of the active substances in oak bark and walnut leaves with respect to inhibition of reverse transcriptase of a wide range of respiratory viruses, as well as the anti-inflammatory effect of the drug. Confirmation of the therapeutic effect of Imupret for the treatment of nasopharyngitis associated with COVID-19 would allow the development of new therapeutic tools to combat this infection and put into practice updated WHO emphasis on national health systems: it is important to identify, treat and isolate all cases of COVID-19, including cases with mild or moderate severity of the disease.

Conditions

Covid19; Nasopharyngitis; Anosmia; Fever; Myalgia; Cough; Nasal Congestion

Outcome Measures

Primary Outcomes (1)

• Day of response to treatment from baseline to end of treatment (up to two weeks) - decrease in the average score of the symptom assessed by the patient (VAS, 0-10 points for each symptom) by 50% compared to baseline.

  patient's assessment of the symptoms 11 Point visual analogue scale 0 - absent symptom, 10 - the maximum severity of the symptom) for rhinorrhea, nasal congestion, rhinolalia, anosmia, sore throat, general condition, fever.

  Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 14)

Secondary Outcomes (1)

• Symptom Dynamics (assessed by patients)

  Every day in the treatment phase up to 14 days

Other Outcomes (1)

• Symptom Dynamics (assessed by docktor)

  At Visit 1 (Day 0) and at Visit 3 (day 14)

Study Arms (2)

Treatment group BNO 1030

ACTIVE COMPARATOR

BNO 1030

Drug: BNO 1030

Control group

OTHER

Standard care

Other: Standard care

Interventions

BNO 1030 DRUG

Imupret 25 drops х 6 times per day for 14 days

Also known as: Imupret

Treatment group BNO 1030

Standard care OTHER

isolation mode symptomatic therapy as needed: antipyretic (paracetamol) saline solutions in the nose x 4 times a day -14 days

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old;
• Clinical signs of a mild form of COVID-19 (acute nasopharyngitis associated with 2019-nCoV), assessed by direct contact or remotely: sudden onset, fever, cough
• \+ at least one of the following:
• nasal congestion;
• discharge from the nose (front and back rhinorrhea);
• anosmia/hyposmia;
• Contact with a confirmed or suspected case of COVID-19
• The possibility of treatment on an outpatient basis subject to the self-isolation mode

You may not qualify if:

• Indications for inpatient treatment
• The presence of immunodeficiency conditions, oncological diseases, chronic diseases of the cardiovascular or broncho-pulmonary system, diabetes mellitus.
• Individual intolerance to the components of the drug.

Sponsors & Collaborators

• Ivano-Frankivsk National Medical University: lead

Study Sites (1)

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, 76000, Ukraine

Location

MeSH Terms

Conditions

COVID-19; Nasopharyngitis; Anosmia; Fever; Myalgia; Cough; Nasal Obstruction

Interventions

imupret; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pharyngitis; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Respiration Disorders; Signs and Symptoms, Respiratory; Nose Diseases; Airway Obstruction; Respiratory Insufficiency

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Vasyl Popovych, Professor

  Ivano-Frankivsk National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department "Otolaringology, children otolaryngology and surdology"

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: May 1, 2020
• Primary Completion: December 19, 2020
• Study Completion: January 8, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)