Trial to Promote Recovery From COVID-19 With Endocrine Therapy

COVID-19 Clinical Trial

— RECOVER  

Official title:

A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04374279
• Other study ID #: COV2003
• Secondary ID: IRB00249425
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: January 2022

Study information

• Verified date: March 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=3 days from enrollment

• Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms

• Able to provide informed consent

Exclusion Criteria:

• Unable to take oral medication

• Pregnant or breastfeeding

• On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry

• Requiring =6L oxygen or respiratory rate =30

• Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry

• Known hypersensitivity to bicalutamide or its components.

• A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin > 3x the upper limit of normal

• Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction < 40%

• Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Drug:
• Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily for 7 days

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who have clinical improvement at day 7 after randomization	Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death	up to 7 days
Secondary	All-cause mortality	Number of participants deceased for any cause	28 days
Secondary	Duration of hospitalization	Number of calendar days in the hospital	up to 60 days
Secondary	Percentage of patients needing upgrade to the intermediate care unit (IMC)		up to 60 days
Secondary	Duration of IMC stay	Number of calendar days in IMC	up to 60 days
Secondary	Percentage of patients needing upgrade to the intensive care unit (ICU)		up to 60 days
Secondary	Duration of ICU stay	Number of calendar days in ICU	up to 60 days
Secondary	Number of participants requiring mechanical ventilation		up to 60 days
Secondary	Duration of mechanical ventilation	Number of calendar days requiring mechanical ventilation	up to 60 days
Secondary	Number of participants experiencing adverse events	Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	up to 60 days