Clinical trial NCT04374279: Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Official title: A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
SARS-CoV 2
Keywords: COVID-19
Coronavirus
COVID
SARS-COV-2
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants who have clinical improvement at day 7 after randomization
timeFrame: up to 7 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 days
measure: Duration of hospitalization
timeFrame: up to 60 days
measure: Percentage of patients needing upgrade to the intermediate care unit (IMC)
timeFrame: up to 60 days
measure: Duration of IMC stay
timeFrame: up to 60 days
measure: Percentage of patients needing upgrade to the intensive care unit (ICU)
timeFrame: up to 60 days
measure: Duration of ICU stay
timeFrame: up to 60 days
measure: Number of participants requiring mechanical ventilation
timeFrame: up to 60 days
measure: Duration of mechanical ventilation
timeFrame: up to 60 days
measure: Number of participants experiencing adverse events
timeFrame: up to 60 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Catherine H Marshall, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: