COVID-19 patients with mild pneumonia MedDRA version: 23.1 Level: PT Classification code 10084380 Term: COVID-19 pneumonia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Veinofytol
Product Name: Veinofytol
Pharmaceutical Form: Tablet
INN or Proposed INN: Veinofytol
Current Sponsor code: CVD19-ESCIN
Other descriptive name: AESCIN
Concentration unit: mg mill
Sponsors
UAB Švencioniu vaistažoles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient age: 18 to 65 years 2. The patient gave informed consent; patients who understand the essence of the study and can independently give the informed consent 3. A positive SARS-CoV-2 sample (nasopharyngeal swab) was determined by RT-PCR 4. Patients diagnosed with mild pneumonia with no identified lesions by chest X-ray 5. Patients who have a fever 6. Premenopausal women who had a negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Fever 37.5 °C more than 14 days after the onset of fever 2. Patients with SpO2 less than 95 % and not treated with O2 therapy 3. Patients with suspected co-fungal infection 4. Patients with congestive heart failure 5. Patients with severe hepatic impairment. 6. Patients with renal insufficiency 7. Patients with impaired consciousness, such as those with dementia 8. Pregnant women 9. Women patients intending to breast-feed 10. Patients with a gout or with hyperuricemia 11. Patients taking immunosuppressants, cancer patients 12. Patients with a recurrent SARS-CoV-2 infection 13. Patients with epilepsy, bronchial asthma 14. Unstable angina pectoris or myocardial infarction within 30 days prior to screening 15. Patients participating in another clinical trial or if participation finished before 3 months 16. Patients have blood purification therapies (hemodialysis, hemofiltration, hemadsorption, plasma exchange, plasma adsorption, peritoneal dialysis, etc.) 17. Patients who develops a disease with diarrhea syndrome 18. Other patients who have been assessed as unfit by the principal investigator or designated physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to determine the therapeutic efficacy of Aesculus Hippocastanum L. seed extract for the COVID-19 disease with mild pneumonia treatment;Secondary Objective: The evaluation of objective measurable indicators (time to improvement in body temperature, SpO2, chest imaging findings, and negative SARS-CoV-2). Also clinical laboratory evaluation of white blood cell count, haemoglobin level, platelet count, blood glucose concentration, serum total bilirubin, creatinine, ALT, AST, electrolytes, (Na+, K+), C-reactive albumin, IL-6, TNF-alfa, ferritin over the study time.;Primary end point(s): The study is aimed to determine whether the efficacy of Aesculus Hippocastanum L. seed extract exceeds the efficacy of maintenance treatment in the control group of SARS-CoV-2 infected patients (Covid-19 disease) with mild pneumonia. The primary endpoint is the determination of the period during which the Covid-19 disease clinical symptoms are reduced, and the patient's condition improves.;Timepoint(s) of evaluation of this end point: Until the end of the clinical trial day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The clinical endpoints of the study, which require regular evaluation in relation to the primary clinic of COVID-19 disease in the assessment of general respiratory symptoms, were selected as secondary endpoints based on their established relevance in clinical practice. They are the following: 1. Changes in the patient's health condition (according to a 10-point scale) 2. Time to the negative SARS-CoV-2 test (RT-PCR) 3. Duration of pyrexia, normalization of body temperature, SpO2 records, and chest radiographic imaging data 4. Changes in expression of clinical symptoms and vital signs 5. Chest imaging picture data on Days 0, 14 (evaluated data of changes) 6. The number (percentage) of patients requiring adjuvant O2 therapy; Duration of oxygen therapy (average) 7. Patients requiring treatment in the intensive care department (percentage), requiring mechanical ventilation therapy (percentage) 8. Clinical laboratory evaluation: white blood cell count, haemoglobin level, platelet count, blood glucose concentration, serum total bilirubin, creatinine, ALT, AST, electrolytes (Na+, K+), C-reactive albumin, IL-6, TNF-alfa, ferritin over the study time.;Timepoint(s) of evaluation of this end point: Until the end of the clinical trial day 28. | — |
Countries
Lithuania
Contacts
Public Contactprojektai@acorus.lt
UAB Švencioniu vaistažoles
Outcome results
None listed