Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB00249425 | Other Identifier | JHM IRB |
Not provided
Not provided
Limited resources.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care and bicalutamide | Active Comparator | Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care |
|
| Standard of care only | No Intervention | Randomized participants receive standard of care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide 150 Mg Oral Tablet | Drug | Bicalutamide 150 mg by mouth daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Number of participants deceased for any cause | 28 days |
| Duration of hospitalization | Number of calendar days in the hospital |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine H Marshall, MD/MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C053541 | bicalutamide |
Not provided
Not provided
Not provided
Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Not provided
Not provided
Not provided
Not provided
| up to 60 days |
| Percentage of patients needing upgrade to the intermediate care unit (IMC) | up to 60 days |
| Duration of IMC stay | Number of calendar days in IMC | up to 60 days |
| Percentage of patients needing upgrade to the intensive care unit (ICU) | up to 60 days |
| Duration of ICU stay | Number of calendar days in ICU | up to 60 days |
| Number of participants requiring mechanical ventilation | up to 60 days |
| Duration of mechanical ventilation | Number of calendar days requiring mechanical ventilation | up to 60 days |
| 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 |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |