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CompletedNCT04797936Updated Mar 15, 2021

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

A Phase 4 interventional study of BNO 1030 and Standard care in Covid19, Nasopharyngitis and Anosmia, sponsored by Ivano-Frankivsk National Medical University. Completed at 1 site in Ukraine. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-15.

Sponsored by Ivano-Frankivsk National Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2020, registered Mar 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19
  • Nasopharyngitis
  • Anosmia
  • Fever
  • Myalgia
  • Cough
  • Nasal Congestion
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 133 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ivano-Frankivsk National Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
133 participants (actual)

Study arms

  • Active comparator
    Treatment group BNO 1030

    BNO 1030

    Drug: BNO 1030

  • Other
    Control group

    Standard care

    Other: Standard care

Interventions

  • DrugBNO 1030

    Imupret 25 drops х 6 times per day for 14 days

    Also known as: Imupret

  • OtherStandard care

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

06

What researchers measure

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.

    Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 14)

Secondary outcomes

  1. Symptom Dynamics (assessed by patients)

    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).

    Time frame: Every day in the treatment phase up to 14 days

Other outcomes

  1. Symptom Dynamics (assessed by docktor)

    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).

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

07

Study locations

1 site
  • Ivano-Frankivsk National Medical University
    Ivano-Frankivsk, 76000, Ukraine
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04797936
Lead sponsor
Ivano-Frankivsk National Medical University
Responsible party
Vasyl Popovych (Head of department "Otolaringology, children otolaryngology and surdology", Ivano-Frankivsk National Medical University) — Principal investigator
First posted
Mar 15, 2021
Start date
May 1, 2020
Primary completion
Dec 19, 2020
Completion
Jan 8, 2021
Last update
Mar 15, 2021

Study contacts

Vasyl Popovych, Professor
principal investigator · Ivano-Frankivsk National Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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