E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Corona virus disease 2019 (COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Corona virus disease 2019 (COVID-19) |
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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 | LLT |
E.1.2 | Classification code | 10053983 |
E.1.2 | Term | Corona virus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Clinical status as assessed by the 7-point ordinal scale up to 30 days after inclusion |
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E.2.2 | Secondary objectives of the trial |
• Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs) • Duration of supplemental oxygen (days) • Need of mechanical ventilation • Laboratory assessment day 0, 2, 4 and 6 • Virus load assessment day 0, 2, 4 and 6 • Hospital stay (days) • Re-admission to hospital due to rebound COVID-19 • Mortality at 6 months
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Positive COVID-19 test - Mild to severe symptoms of COVID-19 - Recent hospitalization due to COVID-19 (0-3 days) - WHO performance status 0-3 - Age above or equal to 50 years - Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. - Estimated expected survival of 1 year (excluding symptoms due to COVID-19) - Women of Childbearing Capacity (WOCBC) must: a) Comply to use of highly effective contraception methods from start of the trial until three months after the last dose of study medication. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk. Women of Childbearing Capacity (WOCBC) must: b) Have a negative pregnancy test - Male patients included in the study that have fertile female partners must use adequate contraception within their relationship from start of the trial until three months after the last dose of study medication.
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E.4 | Principal exclusion criteria |
o Severe allergy to enzalutamide o Pregnant or Breast-feeding women o Need of immediate mechanical ventilation o Current hormonal therapy for prostate and breast cancer (finasteride or dutasteride is allowed) o Treatment for HIV o Treatment with warfarin or Clopidogrel o Treatment with immunosuppressive agents. Allowed exceptions are: equivalent medication to prednisolone 10 mg/day or low dose methotrexate 15 mg/week. Any treatment initiated as standard of care for COVID-19 is allowed. o Severe immunosuppressive disease o Other serious illness or medical condition o Current symptomatic unstable cardiovascular disease o Stroke in medical history o Epileptic seizure in medical history
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to need of mechanical ventilation or death, and time to discharge as assessed by the 7-point ordinal scale up to 30 days after inclusion:
1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7) Death. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 30 days after inclusion. |
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E.5.2 | Secondary end point(s) |
1) Safety evaluation of adverse events; 2) Duration of supplemental oxygen (days); 3) Need of mechanical ventilation; 4) Laboratory assessments; 5) Pharmacokinetic interaction of enzalutamide with other drugs: 6) Virus load; 7) Duration of hospital stay; 8) Re-admission to hospital due to rebound COVID-19; 9) Mortality at 6 months;
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) From randomisation until day 45; 2) From randomisation until day 30 and at the end of follow-up (6 months); 3) From randomisation until day 30 and at the end of follow-up (6 months); 4) Day 0, 2, 4, and 6; 5) Day 6 6) Day 0, 2, 4, and 6; 7) Evaluated for 30 days and at the end of follow-up (6 months); 8) Evaluated for 30 days and at the end of follow-up (6 months); 9) From randomisation until the end of follow-up (6 months);
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 8 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |