E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of COVID-19 infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084268 |
E.1.2 | Term | COVID-19 |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 assess the efficacy of ivermectin compared to placebo in the prevention of laboratory-confirmed COVID-19 infection. |
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E.2.2 | Secondary objectives of the trial |
• To assess the efficacy of ivermectin on Time to RT-PCR positive testing. • To assess the efficacy of ivermectin on the occurence of severe COVID-19 symptoms. • To assess the efficacy of ivermectin on Time to first COVID-19 related clinical events. • To assess the efficacy of ivermectin on the rate of COVID-19 related hospitalisations. • To assess the efficacy of ivermectin on the rate of COVID-19 related mortality. • To assess the safety and tolerability of ivermectin given for a period of 28 days.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age between 18 and 65 years, inclusive. 2. Body weight >45 kg. 3. Body Mass Index >18.5. 4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening. 5. Only one member in the same household will be enrolled. 6. Participants must be able to give informed consent and comply with the study’s scheduled events/visits and study assessments. 7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test. 8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial. Their male partners should also use a contraception method (i.e condom) unless vasectomized. (Refer to section 4.5 Contraception Requirements). 9. Male participants must use a contraception method (i.e condom) for the duration of the trial, unless vasectomized. Their female partners, if they are of childbearing potential, must use a highly effective method of contraception. (Refer to section 4.5 Contraception Requirements). |
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E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding. 2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study. 3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening. 4. Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening. 5. Presence of a known uncontrolled/unstable clinically significant medical condition, considered by the investigator as incompatible with study participation. 6. Known history of HIV, HBV and/or HCV. 7. Hypersensitivity to any component of ivermectin. 8. Participants who have been administered ivermectin within 30 days prior to screening. 9. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first. 10. Having undergone extensive bowel resection which may alter ivermectin absorption. 11. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). 12. Known or clinically suspected disturbance of the blood-brain-barrier (e.g., ABCB-1 [=MDR1] mutation). 13. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. 14. Current use of P-gp inhibitor drugs such as amiodarone, azithromycin, ketoconazole, cyclosporine. 15. Current use of monoclonal antibodies for the treatment of COVID-19. 16. Known drug or alcohol abuse. 17. Travel to endemic Loa loa regions within the past 3 months prior to screening (central and western Africa). 18. Participants under legal guardianship or trusteeship. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Time to change from baseline in negative RT-PCR to positive RT-PCR. • Change from baseline in the WHO-COVID 19 and NEWS-2 scores. • Time to change from baseline to first COVID-19 related clinical events. • Proportion of COVID-19 related hospitalisations. • Proportion of COVID-19 related mortality. • Safety and Tolerability of ivermectin based on treatment emergent adverse events (TEAE) and serious adverse events (SAE) according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 4, Day 7, Day 10, Day 28 and day 56 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
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 | 16 |
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
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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 | 11 |
E.8.9.1 | In the Member State concerned days | 0 |