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

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

Tracking Information
First Submitted Date  ICMJE March 8, 2021
First Posted Date  ICMJE March 15, 2021
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE May 1, 2020
Actual Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2021)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2021)
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Nasopharyngitis
  • Anosmia
  • Fever
  • Myalgia
  • Cough
  • Nasal Congestion
Intervention  ICMJE
  • Drug: BNO 1030
    Imupret 25 drops х 6 times per day for 14 days
    Other Name: Imupret
  • Other: Standard care
    isolation mode symptomatic therapy as needed: antipyretic (paracetamol) saline solutions in the nose x 4 times a day -14 days
Study Arms  ICMJE
  • Active Comparator: Treatment group BNO 1030
    BNO 1030
    Intervention: Drug: BNO 1030
  • Control group
    Standard care
    Intervention: Other: Standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2021)
133
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 8, 2021
Actual Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04797936
Other Study ID Numbers  ICMJE BERI_UA_IMU_2020_000003751
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vasyl Popovych, Ivano-Frankivsk National Medical University
Study Sponsor  ICMJE Ivano-Frankivsk National Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vasyl Popovych, Professor Ivano-Frankivsk National Medical University
PRS Account Ivano-Frankivsk National Medical University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP