BNO 1030 Extract (Imupret) in the Treatment of Mild Forms of COVID-19
Condition: Covid19; Nasopharyngitis; Anosmia; Fever; Myalgia; Cough; Nasal Congestion
MeSH terms: COVID-19; Nasopharyngitis; Myalgia; Anosmia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): BNO 1030; Standard care
Intervention type(s): Drug; Other
Intervention description(s): Imupret 25 drops х 6 times per day for 14 days; isolation mode symptomatic therapy as needed: antipyretic (paracetamol) saline solutions in the nose x 4 times a day -14 days
Other intervention name(s): Imupret
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment