COVID-19 MedDRA version: 23.1 Level: LLT Classification code 10084355 Term: COVID-19 virus test positive System Organ Class: 100000004848
Conditions
Sponsors
Mitochon Technologies Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be randomized in this clinical research trial only if they meet all of the following criteria: 1. Male and female patients between age of 65 and 80 years 2. Confirmed positive rapid antigen test for SARS-CoV-2 in the previous 72 hours. 3. Not requireing immediate hospitalization 4. Oxygen Saturation = 95 % 5. Having at least one of the following conditions: a. Documented and treated diabetes b. Documented and treated hypertension c. Documented and treated chronic cardiovascular disease d. BMI> 30 6. Ability to comprehend and willingness to sign statements of the Informed Consent Form 7. Willingness to undergo Protocol required physical, laboratory and self examinations. 8. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective double barrier contraception, being a condom for male patients and a highly effective form of contraception for the his female partner of childbearing potential a. male patients practicing true sexual abstinence (when this in line with the preferred and usual lifestyle of the participant) can be included b. sterilized male patients who have had vasectomy with documented post procedure aspermia, can be included Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 660
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics/conditions will not be randomized in this clinical research trial: 1. Patient with malignancy or history of malignancy (including lymphoma, leukemia, orly mphoproliferative disease) with the exception of patients with adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. 2. Any known coagulopathy or hypercoagulant syndrome 3. Participant with a known immunodeficiency disorder 4. History of major surgery that involves major organs (e.g. brain, gastrointestinal tract heart, lung, liver, hip or knee joint prosthesis, kidney or bladder, lower limb amputation) within 3 months. 5. Planned surgery scheduled to occur during the study including the follow-up period. 6. Impaired renal function (eGFR160 Hgmm or diastolic pressure >100 Hgmm) 19. Uncontrolled diabetes mellitus ( HbA1c > 9%) 20. History of major organ transplant (eg. heart, lung, kidney and liver) or hemopoietic stem cell/marrow transplant. 21. Patient who permanently rests in bed (for more than one month, 20 hours/day) 22. Documented severe depression treated with SSRI. Acute or chronic psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour. 23. Documented treated or untreated Alzheimer diesease. 24. Body mass index: BMI37 25. Patient who participated in any clinical research trial within 3 months 26. Clinically meaningful laboratory abnormalities at screening including but not limited to the ranges below a. Absolute neutrophil count (ANC) <1000/µL XML File Identifier: TRwFNpbAFWLGK0+YFea74J6Citk= Page 12/23 b. Total white blood cell count (WBC) <2,500/µL c. Platelet count <100,000/µL d. Haemoglobin <9.0 g/L e. Alanine Aminotransferase (ALT) or Aspartate Aminot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if the administration of single agent BGP-15 compared to placebo results in a significant decrease in hospitalisations of newly detected SARS-CoV-2 positive, high risk patients.;Secondary Objective: The secondary objectives of this study are to determine if the administration of single agent BGP-15 compared to placebo results in a significant change in - the number of patients requiring acute mechanical ventilation during the treatment or Follow-up period, - mortality due to COVID-19 related reasons during the treatment or Follow-up period, - oxygen saturation, - Interleukin-6 levels - dyspnea functional limitations and - Adverse Events and Serious Adverse Events.;Primary end point(s): The difference in proportion of patients, who have not required hospitalisation in relation to COVID-19 between Day 3 and End of Treatment;Timepoint(s) of evaluation of this end point: End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Between Screening and End of Treatement;Secondary end point(s): - The difference in proportion of patients, who have not required acute mechanical ventilation between Day 3 and end of Follow-up period. - The difference in proportion of patients, who have survived between Day 3 and end of Follow-up period. - Treatment effects on SatO2%. - Treatment effects on IL-6. - Safety parameters: Adverse Events (AEs), Serious Adverse Events (SAEs) | — |
Countries
Hungary
Contacts
Public ContactClinical Trial Information
Mitochon Technologies Kft.
Outcome results
None listed