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Covid19Phase 4NCT04797936

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

A Phase 4 study testing BNO 1030 in people with Covid19 and Nasopharyngitis, run by Ivano-Frankivsk National Medical University at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Covid19, Nasopharyngitis, Anosmia
What is being tested?
BNO 1030
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteUkraine
Study dates
1 May 2020to 8 Jan 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Ivano-Frankivsk National Medical University

    Ivano-Frankivsk, 76000

Other trials in Ukraine

About this study

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

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.

Being tested
BNO 1030, Standard care
Medical subject headings
COVID-19, Nasopharyngitis, Anosmia, Fever, Myalgia, Cough, Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNO 1030Drug

    Also called Imupret

    Imupret 25 drops х 6 times per day for 14 days

  • Standard careOther

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

Study groups in NCT04797936
Study groupRoleWhat they receive
Treatment group BNO 1030Active comparatorBNO 1030
Receives: Drug: BNO 1030
Control groupOtherStandard care
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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).

    Measured: Every day in the treatment phase up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start1 May 2020
  3. Primary completion19 Dec 2020
  4. Study completion8 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797936
Sponsor's protocol ID
BERI_UA_IMU_2020_000003751
Status last verified
Mar 2021
First submitted
8 Mar 2021
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BNO 1030 in people with Covid19 and Nasopharyngitis, run by Ivano-Frankivsk National Medical University at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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