RECOVER: Trial to Promote Recovery From COVID-19 With Endocrine Therapy

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04374279
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; SARS-CoV 2	Drug: Bicalutamide 150 Mg Oral Tablet	Phase 2

Study Design

• Study Type: Interventional
• 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.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
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Arms and Interventions

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 Names: Casodex
No Intervention: Standard of care only Randomized participants receive standard of care only.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. All-cause mortality [28 days]

   Number of participants deceased for any cause

2. Duration of hospitalization [up to 60 days]

   Number of calendar days in the hospital

3. Percentage of patients needing upgrade to the intermediate care unit (IMC) [up to 60 days]

4. Duration of IMC stay [up to 60 days]

   Number of calendar days in IMC

5. Percentage of patients needing upgrade to the intensive care unit (ICU) [up to 60 days]

6. Duration of ICU stay [up to 60 days]

   Number of calendar days in ICU

7. Number of participants requiring mechanical ventilation [up to 60 days]

8. Duration of mechanical ventilation [up to 60 days]

   Number of calendar days requiring mechanical ventilation

9. Number of participants experiencing adverse events [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

• Principal Investigator: Catherine H Marshall, MD/MPH, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT04374279
• Other Study ID Numbers: COV2003; IRB00249425
• First Posted: May 5, 2020
• Last Update Posted: Mar 5, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: COVID-19; Coronavirus; COVID; SARS-COV-2
• Additional relevant MeSH terms: COVID-19; Bicalutamide

Study Results

No Results Posted as of Mar 5, 2021