A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19)

A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19) - COVIDENZA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002027-10-SE

Enrollment

600

Registered

2020-04-24

Start date

2020-07-13

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona virus disease 2019 (COVID-19) MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862

Interventions

Trade Name: Xtandi Product Name: Xtandi Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Clinical status as assessed by the 7-point ordinal scale up to 30 days after inclusion;Secondary Objective: • 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 ;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.;Timepoint(s) of evaluation of this end point: Up to 30 days after inclusion.	—

Measure

Time frame

Main Objective: Clinical status as assessed by the 7-point ordinal scale up to 30 days after inclusion;Secondary Objective: • 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 ;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.;Timepoint(s) of evaluation of this end point: Up to 30 days after inclusion.

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Secondary

Measure	Time frame
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; ;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);	—

Measure

Time frame

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; ;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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Countries

Sweden

Contacts

Public ContactSponsor's representative

Norrlands universitetssjukhus

andreas.josefsson@umu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026