BGP-15 effect on the hospitalization rate of COVID-19 patients
- Conditions
- COVID-19MedDRA version: 23.1Level: LLTClassification code 10084355Term: COVID-19 virus test positiveSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005539-62-HU
- Lead Sponsor
- Mitochon Technologies Kft.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
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
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 (eGFR<30 ml/min/1,73m2), renal failure,
hystory of dialysis treatment
7. Documented biological immunomodulatory therapy within 3 months
8. Patient with any of the following infections or infections history:
a. any infection requiring hospitalization, parenteral antimicrobal
therapy within 60 days, or as otherwise judged by the investigator to be
an opportunistic infection or clinically significant, within the last 6
months;
b. Moderate to severe treated infection within 1 month
9. Active moderate to severe Crohn's disease or ulcerative colitis within
3 month
10. Documented severe pulmonary fibrosis, emphysema, COPD or
pneumonectomy
11. Documented mycobacterial infection, aspergillosis, pneumocystosis,
tuberculosis within the last 3 years. Any history of either untreated or
inadequatly treated latent or active tuberculosis infection, current
treatment for active
12. Mechanical ventilation (minimum 7 days) within 3 months
13. Documented history of Human Immunodeficiency Virus infection
14. Documented present or past hepatitis B or hepatitis C infection
15. Patient with ischemic or haemorrhagic stroke, meningitis or
encephalitis within 6 months
16. Hemiplegia due to any reason
17. Recent (within 6 months of screening) myocardial infarction,
coronary revascularization, or percutaneous angioplasty with or without
placement of a coronary artery stent; acute coronary syndrome; chronic
uncompensated heart failure or New York Heart Association (NYHA)
Functional Class III or IV; left ventricular assist devices; implanted
defibrillators, unstable angina
18. Uncontrolled hypertension (systolic pressure >160 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: BMI<15 or BMI>37
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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,<br>- mortality due to COVID-19 related reasons during the treatment or<br>Follow-up period,<br>- oxygen saturation,<br>- Interleukin-6 levels<br>- dyspnea functional limitations and<br>- Adverse Events and Serious Adverse Events.;Primary end point(s): The difference in proportion of patients, who have not required<br>hospitalisation in relation to COVID-19 between Day 3 and End of<br>Treatment;Timepoint(s) of evaluation of this end point: End of Treatment
- Secondary Outcome Measures
Name Time Method 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<br>mechanical ventilation between Day 3 and end of Follow-up period.<br>- The difference in proportion of patients, who have survived between<br>Day 3 and end of Follow-up period.<br>- Treatment effects on SatO2%.<br>- Treatment effects on IL-6.<br>- Safety parameters: Adverse Events (AEs), Serious Adverse Events<br>(SAEs)