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Bicalutamide 150 Mg Oral TabletWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2122 Placebo Wiki 0.04

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D000856 Anorexia Nervosa NIH 0.71
D000855 Anorexia NIH 0.71
D007239 Infection NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002039 Anorexia HPO 0.71

There are 2 clinical trials

Clinical Trials

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

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.

NCT04374279 COVID-19 SARS-CoV 2 Drug: Bicalutamide 150 Mg Oral Tablet

Primary Outcomes

Description: 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

Measure: Percentage of participants who have clinical improvement at day 7 after randomization

Time: up to 7 days

Secondary Outcomes

Description: Number of participants deceased for any cause

Measure: All-cause mortality

Time: 28 days

Description: Number of calendar days in the hospital

Measure: Duration of hospitalization

Time: up to 60 days

Measure: Percentage of patients needing upgrade to the intermediate care unit (IMC)

Time: up to 60 days

Description: Number of calendar days in IMC

Measure: Duration of IMC stay

Time: up to 60 days

Measure: Percentage of patients needing upgrade to the intensive care unit (ICU)

Time: up to 60 days

Description: Number of calendar days in ICU

Measure: Duration of ICU stay

Time: up to 60 days

Measure: Number of participants requiring mechanical ventilation

Time: up to 60 days

Description: Number of calendar days requiring mechanical ventilation

Measure: Duration of mechanical ventilation

Time: up to 60 days

Description: 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

Measure: Number of participants experiencing adverse events

Time: up to 60 days

2 Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection

COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.

NCT04509999 COVID-19 Drug: Bicalutamide 150 Mg Oral Tablet Drug: Placebo
MeSH:Infection

Primary Outcomes

Description: COVID-19 symptom relief at day 28, and % of COVID-19 symptom relief and its 95% confidence interval (CI) will be calculated using the exact binomial distribution and compared using Fisher's exact test.

Measure: Proportion x 100 = percent of patients with improved COVID-19 symptoms

Time: Day 28

No related HPO nodes (Using clinical trials)