E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
confirmed SARS-CoV-2 infection |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal exclusion criteria |
1. Critical patients with expected survival time < 72 hours
2. Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring
3. Participation in the trial is not in the patient`s best interest based on the judgement of the Investigator
4. Presence of the following laboratory values at screening
• White blood cell count <1,5X109/L
• Platelet count< 100000 mm3(<100 X109/L)
• Total bilirubin>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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of subjects converted to negative SARS-CoV-2 (qualitative) test on Days 7 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 4, 7, 9, 12, 14,
Until Day 28 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |