Covid-19 disease MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 100000004862
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ivermectin
Other descriptive name: IVERMECTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceuti
Sponsors
Fakultní nemocnice u sv. Anny v Brne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 18 years 2) Willingness to participate in the clinical trial expressed by signing the informed consent form 3) Patients with confirmed Covid-19 disease requiring hospitalization with at least one of the following symptoms: a. febrile illness above 38.5 ° C; b. shortness of breath at rest or with minimal exertion, c. oxygen-free saturation below 93 % SpO2, d. inability to self-service, general exhaustion and more 4) Laboratory PCR confirmed positivity SARS-CoV-2 (nasopharyngeal swab) or positive antigen test not older than 5 days. 5) Clinical trial subjects of childbearing potential must agree to the use of the following methods of contraception for the duration of clinical trial and 3 months after the end of clinical trial. a. For women of childbearing potential using one of the following methods: i. highly reliable contraceptive methods within 3 months after end of clinical trial: combined hormonal contraception (oral, vaginal, transdermal), progesterone-containing contraceptives with ovulation inhibition (oral, injection), intrauterine non-hormonal or hormonal body, bilateral tubal occlusion or partner vasectomy OR ii. sexual abstinence if it is consistent with the lifestyle of the subject. b. For men, use one of the following methods: observance of sexual abstinence (if it is consistent with the lifestyle of the subject) or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse within 3 months after the end of clinical trial. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1) Pregnancy, breastfeeding, positive chorionic gonadotropin (hCG) 2) Inadequacy of classification of the subject on the basis of individual assessment of the examining physician 3) Age 3x ULN detected before IP administration 6) Known hypersensitivity to the components of the preparation 7) Eating and fluid intake disorders and conditions limiting the bioavailability of the drug 8) Participation in another clinical trial 9) BMI > 35 10) Inability to swallow drugs 11) Current use of potent CYP3A4 inhibitors: fluconazole, fluoxetine, indinavir, itraconazole, clarithromycin, nifedipine, ritomavir, verapamil, voriconazole 12) Use of ivermectin 1 month before inclusion in CT 13) Bone marrow transplantation, history of hematopoietic disorders 14) Neurological disorders such as epilepsy that are treated with GABA agonists, such as baclofen, or past suicidal ideation or attempts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the clinical safety of ivermectin versus placebo as an add-on therapy to the standard treatment of COVID-19 disease in both treatment arms. ;Secondary Objective: - Evaluation of the condition of patients at the level of 8-level Ordinal Scale S1 on individual days of the clinical trial - Time to first improvement by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1 - Time to first deterioration by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1 - Duration (days) of need for oxygen therapy - Length (days) of the need for non-invasive ventilation or high flow oxygenation - Duration (days) of need for intubation and mechanical ventilation or organ support by vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO) - Mortality - Length (days) of need for hospitalization - change of X-ray findings on the lungs during the 10th day - upon the invetigator's decision and the length of hospitalization (control X-ray on the 10th day or on the day of discharge - in case of a clinical reason) - Evaluation of concomitant treatment in both arms - Evaluation of the change in viral load as a function of time ;Primary end point(s): 1. Severity, expectations, intensity AE and association with IP and placebo 2. Nature of AE, duration 3. Improvement by at least one grade at the 8-level Ordinal Scale S1 assessment level, assessed on day 10 after the first IP / placebo administration;Timepoint(s) of evaluation of this end point: 1. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 2. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 3. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evaluation of the condition of patients at the level of 8-level Ordinal Scale S1 on individual days of clinical trial (until day 28) 2. Time to first improvement by 1 category compared to Day 1 on the 8-speed Ordinal Scale S1 (until day 28) 3. Time to first deterioration by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1 (until day 28) 4. Duration (days) of necessity of oxygen therapy (until day 28) 5. Duration (days) of the need for non-invasive ventilation or high flow oxygenation (until day 28) 6. Duration (days) of need for intubation and mechanical ventilation or organ support by vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO) (until day 28) 7. Mortality (until day 28) 8. Length (days) of need for hospitalization (until day 28) 9. Change of X-ray findings on the lungs during the 10th day - according to the doctor's decision and according to the length of hospitalization (control X-ray on 10th day or on the day of discharge will be performed if there is a clinical reason for this - f.e. listening findings) 10. Evaluation of concomitant treatment in both arms 11. Evaluation of the change in viral load over time 12. Serum concentration of C-Reactive Protein (CRP) 13. Number of subjects with increased alanine aminotransferase ALT and / or AST aspartate aminotransferase> 3x ULN ;Timepoint(s) of evaluation of this end point: 1.Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 2. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 3. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 4.Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 5. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 6. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 7. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 8. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 9. Day 1 (Day 10) 10. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28 11. Day 1, Day 7 12. Day 1, Day 3, | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických studií
Fakultní nemocnice u sv. Anny v Brne
Outcome results
None listed