Enzalutamide Treatment in COVID-19

COVID-19 Clinical Trial

— COVIDENZA  

Official title:

A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04475601
• Other study ID #: COVIDENZA
• Status: Terminated
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: May 29, 2021

Study information

• Verified date: August 2021
• Source: Region Västerbotten
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: May 29, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Positive COVID-19 test

• Mild to severe symptoms of COVID-19

• Hospitalization

• 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)

Exclusion Criteria:

• Severe allergy to Enzalutamide

• Pregnant or breast-feeding women

• Need of immediate mechanical ventilation

• Current medication includes enzalutamide treatment

• Stroke or Transitory Ischemic attack in medical history

• Treatment for HIV

• Treatment with tamoxifen

• Treatment with immunosuppressive agents

• Severe immunosuppressive disease

• Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)

• Previous seizure in medical history

• Other serious illness or medical condition

• Unstable cardiovascular disease

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19

Intervention

Drug:
• Enzalutamide Pill
The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Ryhovs Hospital	Jönköping	Småland
Sweden	Linköping University Hospital	Linköping
Sweden	Anders Bjartell	Malmö	Skåne
Sweden	Sundsvall Region Hosptial	Sundsvall
Sweden	Umeå Univerisity Hospital	Umeå

Sponsors (12)

Lead Sponsor	Collaborator
Andreas Josefsson	Astellas Pharma Europe Ltd., Göteborg University, Helsingborgs Hospital, Jonkoping County Hospital, Norrlands University Hospital, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Sundsvall Hospital, Umeå University, University Hospital, Umeå, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to worsening of disease	Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale	Up to 30 days after inclusion
Primary	Time to improvement of disease	Time to discharge from hospital assessed by the 7-point ordinal scale	Up to 30 days after inclusion
Secondary	Adverse events	Safety evaluation, as measured by AEs	Up to 6 months
Secondary	Duration of supplemental oxygen (days)	Total days of extra oxygen	Up to 30 days
Secondary	Admission to ICU	Frequence of admission to ICU	Up to 30 days and up to 6 months
Secondary	Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6	Changes of laboratory parameters: Hb	Up to 30 days
Secondary	Virus load assessment day 0, 2, 4 and 6	PCR based SARS-CoV-2 measurement from upper respiratory tract	UP to 7 days
Secondary	Hospital stay (days)	Total number of days evaluated at 30 days and 6 months	Up to30 days and 6 months
Secondary	Re-admission to hospital due to rebound COVID-19	If admitted to hospital due to COVID-19 disease after discharge from hospital	Evaluated for 30 days and after 6 months
Secondary	Mortality at 6 months	Death due to any cause	up to 30 days and up to 6 months respectively
Secondary	Laboratory assessment of CRP concentration day 0, 2, 4 and 6	Changes of laboratory parameters: CRP	Up to 30 days
Secondary	Laboratory assessment of liver function day 0, 2, 4 and 6	Changes of laboratory parameters: ALAT, ASTA and/or ALP	Up to 30 days
Secondary	Laboratory assessment of creatinine concentration day 0, 2, 4 and 6	Changes of laboratory parameters: Createnin	Up to 30 days
Secondary	Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6	Changes of laboratory parameters: D-dimer	Up to 30 days
Secondary	Laboratory assessment of platelets concentration day 0, 2, 4 and 6	Changes of laboratory parameters: TPK	Up to 30 days
Secondary	Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6	Changes of laboratory parameters: IL-6	Up to 30 days
Secondary	Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6	Changes of laboratory parameters: Differentiate count of leucocytes	Up to 30 days
Secondary	Pharmacokinetic interaction of enzalutamide with steroids	Maximum Plasma Concentration [Cmax] of steroids in blood	Up to 30 days

External Links

•   Homepage of the trial
•   Publication of the results