Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04374279 |
Recruitment Status :
Withdrawn
(Limited resources.)
First Posted : May 5, 2020
Last Update Posted : March 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 SARS-CoV 2 | Drug: Bicalutamide 150 Mg Oral Tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy |
Estimated Study Start Date : | April 2021 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard of care and bicalutamide
Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
|
Drug: Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily for 7 days
Other Name: Casodex |
No Intervention: Standard of care only
Randomized participants receive standard of care only.
|
- Percentage of participants who have clinical improvement at day 7 after randomization [ Time Frame: up to 7 days ]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
- All-cause mortality [ Time Frame: 28 days ]Number of participants deceased for any cause
- Duration of hospitalization [ Time Frame: up to 60 days ]Number of calendar days in the hospital
- Percentage of patients needing upgrade to the intermediate care unit (IMC) [ Time Frame: up to 60 days ]
- Duration of IMC stay [ Time Frame: up to 60 days ]Number of calendar days in IMC
- Percentage of patients needing upgrade to the intensive care unit (ICU) [ Time Frame: up to 60 days ]
- Duration of ICU stay [ Time Frame: up to 60 days ]Number of calendar days in ICU
- Number of participants requiring mechanical ventilation [ Time Frame: up to 60 days ]
- Duration of mechanical ventilation [ Time Frame: up to 60 days ]Number of calendar days requiring mechanical ventilation
- Number of participants experiencing adverse events [ Time Frame: up to 60 days ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374279
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21231 |
Principal Investigator: | Catherine H Marshall, MD/MPH | Johns Hopkins University |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT04374279 |
Other Study ID Numbers: |
COV2003 IRB00249425 ( Other Identifier: JHM IRB ) |
First Posted: | May 5, 2020 Key Record Dates |
Last Update Posted: | March 5, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus COVID SARS-COV-2 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Bicalutamide Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents |