Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04797936 |
| Other study ID # |
BERI_UA_IMU_2020_000003751 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
January 8, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Ivano-Frankivsk National Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
