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Trial - NCT04374279


Column Value
Trial registration number NCT04374279
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04374279

First author
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Catherine H Marshall, MD/MPH

Contact
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

chm@jhmi.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-05

Recruitment status
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Other Name: Casodex", "treatment_id": 204, "treatment_name": "Bicalutamide", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]