confirmed SARS-CoV-2 infection
Conditions
Interventions
Product Code: HUVE-19
Pharmaceutical Form: Tablet
INN or Proposed INN: ivermectin
CAS Number: 70288-86-7
Current Sponsor code: HUVE-19
Other descriptive name: 22,23-Dihydroavermectin B1
Concentration
Sponsors
HUVEPHARMA EOOD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients at least 18 years old 2. Signed informed consent 3. Admitted to hospital for treatment of COVID -19. The hospitalization must be for medical and not for social reasons. 4. Patient within 7 days from symptom onset and within 72 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR) 5. Mild to Moderate COVID-19 disease defined as clinical status category 3 or 4 on the WHO 9-point ordinal scale • Hospitalized, no oxygen treatment • Oxygen by mask or nasal prongs 6. Presence of at least 1 symptom characteristic for COVID-19 disease, e.g. fever, cough, sore throat, myalgia, fatigue, GI disorders, skin lesions etc 7. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study 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 40
Exclusion criteria
Exclusion criteria: 1. Critical patients with expected survival time 2 X upper limit of normal (ULN) • Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) > 3 X ULN 5. Clinical suspicion for a bacterial superinfection at screening 6. Allergic or hypersensitive to the IMP or any of the ingredients 7. Patients who cannot take drugs orally, or have severe gastro-intestinal disorders, extensive bowel resection or bowel obstruction. 8. Previous (in the past 3 months) or concurrent use of any other Investigational product (IP) 9. Use of the prohibited medications during the treatment with IP, as defined in the protocol; 10. Patients with end stage liver disease (Child Pugh C score) 11. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class III or 4) 12. Presence of acute stroke at screening or a history of acute stroke within the last 6 months. 13. Pregnant or breastfeeding 14. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial. 15. Patients who are institutionalized due to judicial order. 16. An employee or immediate relative of the Investigator or Sponsor. 17. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma and COPD), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastro-intestinal disorder, that according to Investigator could jeopardize the safety of the patient, or the integrity of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on the qualitative virological clearance in upper respiratory tract swab samples on Day 7. ;Secondary Objective: 1. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on clinical improvement on Day7 and Day14 2. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on clinical recovery on Day 7 and Day 14. Additional secondary objectives 1. To evaluate the efficacy of Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC in the treatment of coronavirus disease 2019 (COVID-19) based on different additional clinical endpoints 2. To evaluate the effect of treatment with Ivermectin plus investigator’s choice of standard of care therapy (SoC) vs placebo plus SoC on hematology and inflammatory markers ;Primary end point(s): Rate of subjects converted to negative SARS-CoV-2 (qualitative) test on Days 7;Timepoint(s) of evaluation of this end point: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Number of patients achieving clinical recovery on Day 7 •Number of patients achieving clinical recovery on Day 14 Additional secondary end points •Time to conversion to a negative SARS-CoV-2 (qualitative) test until Day 28 •Time to achieving clinical improvement until Day 28 •Time to achieving clinical recovery until Day 28 •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 4 •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 9 and Day 12 •Rate of subjects conversion converted to a negative SARS-CoV-2 (qualitative) test on Day 14 •Time to hospital discharge •Number of patients who have needed high flow oxygen therapy •Number of patients who have needed ICU treatment •Inflammatory and FBC markers ;Timepoint(s) of evaluation of this end point: Day 4, 7, 9, 12, 14, Until Day 28 | — |
Countries
Bulgaria
Contacts
Public ContactSpas Petkov
HUVEPHARMA EOOD
Outcome results
None listed