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

• ClinicalTrials.gov Identifier: NCT04797936
• Recruitment Status: Completed
• First Posted: March 15, 2021
• Last Update Posted: March 15, 2021
• Sponsor: Ivano-Frankivsk National Medical University
• Information provided by (Responsible Party): Vasyl Popovych, Ivano-Frankivsk National Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19; Nasopharyngitis; Anosmia; Fever; Myalgia; Cough; Nasal Congestion	Drug: BNO 1030; Other: Standard care	Phase 4

Detailed Description:

The new coronavirus (2019-nCoV) from Wuhan is currently of great concern, as the virus is spreading rapidly around the world and the number of cases and deaths is constantly growing. The main cause of death is the severe course of COVID-19 disease, which includes pneumonia, acute respiratory distress syndrome (ARDS), sepsis, and septic shock. As the spread of COVID-19 is progressing worldwide, the focus is on the rapid identification, testing, and treatment of patients with severe COVID-19 and the hospitalization of people with the highest risk of fatal outcomes.

Less attention is paid to cases of mild disease. According to WHO data, about 40% of patients with COVID-19 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. An infected person, even with minor clinical symptoms, can infect between 1.5 and 3.5 people and spread the virus among approximately 368 people in just five infection cycles. 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. South Korea, China, and Italy have already proven that a significant number of patients with proven COVID-19 infection developed anosmia/hyposmia. In Germany, more than 2 out of 3 confirmed cases are reported to have anosmia. 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. However, 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.

Fever, cough, sore throat, nasal congestion, malaise, headache, muscle pain, and decreased sense of smell are typical symptoms of acute nasopharyngitis. It is believed that the previously described coronaviruses account for 10-15% of cases of nasopharyngitis, so it is not surprising that the new COVID-19 virus can also cause anosmia in infected patients. These patients need isolation and treatment because they are covert carriers that contribute to the rapid spread of COVID-19.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Multicentre, Comparative Study of Therapeutic Efficacy, Safety, and Tolerability of BNO 1030 Extract, in the Treatment of Mild Forms of COVID-19
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: December 19, 2020
• Actual Study Completion Date: January 8, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treatment group BNO 1030; BNO 1030	Drug: BNO 1030; Imupret 25 drops х 6 times per day for 14 days; Other Name: Imupret
Control group; Standard care	Other: Standard care; isolation mode symptomatic therapy as needed: antipyretic (paracetamol) saline solutions in the nose x 4 times a day -14 days

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 14) ]
   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.

Secondary Outcome Measures :

1. Symptom Dynamics (assessed by patients) [ Time Frame: Every day in the treatment phase up to 14 days ]
   Symptom measurement by patient's self assessment (General condition, sore throat, fever, rhinorrhea, cough, nasal congestion via ten-point visual analogue scale (VAS, 0 - 10 points (0- no symptom; 10 -maximal expression of the symptom).

Other Outcome Measures:

1. Symptom Dynamics (assessed by docktor) [ Time Frame: At Visit 1 (Day 0) and at Visit 3 (day 14) ]
   Symptom measurement by doctors (General condition, sore throat, fever, rhinorrhea, cough, nasal congestion via 5-point criteria: 0-4 points/symptom. 0 - none symptom; 1- mild; 2- moderate; 3- severe; 4- very severe).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

Ukraine

Ivano-Frankivsk National Medical University

Ivano-Frankivsk, Ukraine, 76000

Sponsors and Collaborators

Ivano-Frankivsk National Medical University

Investigators

• Principal Investigator: Vasyl Popovych, Professor; Ivano-Frankivsk National Medical University

More Information

• Responsible Party: Vasyl Popovych, Head of department "Otolaringology, children otolaryngology and surdology", Ivano-Frankivsk National Medical University
• ClinicalTrials.gov Identifier: NCT04797936
• Other Study ID Numbers: BERI_UA_IMU_2020_000003751
• First Posted: March 15, 2021
• Last Update Posted: March 15, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Nasopharyngitis; Myalgia; Anosmia; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Olfaction Disorders; Sensation Disorders; Pharyngitis; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases