Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization

NCT04397718 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: COVID19-8900-15
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15

  Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.

  15 days

Secondary Outcomes (7)

• Time to Clinical Improvement

  Through discharge (an average of 8 days with a maximum of 2.5 months)

• Inpatient Mortality

  Through discharge (an average of 8 days with a maximum of 2.5 months)

• Duration of Hospitalization

  Through discharge (an average of 8 days with a maximum of 2.5 months)

• Duration of Intubation

  Through discharge (an average of 8 days with a maximum of 2.5 months)

• Time to Normalization of Temperature.

  Through discharge (an average of 8 days with a maximum of 2.5 months)

Study Arms (2)

Placebo + BSC

PLACEBO COMPARATOR

No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.

Other: Saline

Degarelix + BSC

EXPERIMENTAL

Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.

Drug: Degarelix

Interventions

Degarelix DRUG

Degarelix is an FDA-approved drug for prostate cancer

Degarelix + BSC

Saline OTHER

09% Saline

Placebo + BSC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male Veterans admitted to a VA hospital.
• Age \> 18
• Hospitalized on an acute care ward with a diagnosis of COVID-19 contributing to hospitalization.
• Positive RT-PCR assay for SARS-CoV-2 on a nasopharyngeal swab sample.
• Severity of illness of level 3, 4 or 5 on the influenza severity scale (see Appendix A) at the time of randomization.
• The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.

You may not qualify if:

• History of severe hypersensitivity to degarelix or any component of their respective formulation.
• History of congenital long QT syndrome or known history of prolonged QT interval corrected by the Fridericia correction formula (QTcF) \> 500 msec on electrocardiogram performed at screening.
• Planned discharge within 24 hours of treatment initiation.
• Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
• Ongoing usage of a Class IA or Class III antiarrhythmic agent. At least 5 half lives must elapse since any prior use of a Class IA or III antiarrhythmic agent prior to administration of study drug.
• Baseline electrolyte abnormalities of Grade 3 or higher (based on CTCAE v5.0 criteria). Patients may be included if baseline electrolyte abnormalities are corrected to Grade 2 or lower prior to study drug administration.
• Myocardial infarction in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease.
• Enrollment in another investigational study within 30 days of Day 1.
• Known psychiatric or substance abuse disorder that would interfere with the requirements of the trial.
• Child-Pugh Class C liver disease.
• Use of any of the following hormonal agents within Day 1 of treatment:
• Androgen receptor antagonists or agonists within 4 weeks,
• Ketoconazole or abiraterone acetate within 2 weeks,
• Estrogens or progestins within 2 weeks,
• Herbal products that contain hormonally active agents within 2 weeks.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (14)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484, United States

Location

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Los Angeles, California, 90073, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY

Brooklyn, New York, 11209, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Philadelphia MultiService Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19106, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Nickols NG, Mi Z, DeMatt E, Biswas K, Clise CE, Huggins JT, Maraka S, Ambrogini E, Mirsaeidi MS, Levin ER, Becker DJ, Makarov DV, Adorno Febles V, Belligund PM, Al-Ajam M, Muthiah MP, Montgomery RB, Robinson KW, Wong YN, Bedimo RJ, Villareal RC, Aguayo SM, Schoen MW, Goetz MB, Graber CJ, Bhattacharya D, Soo Hoo G, Orshansky G, Norman LE, Tran S, Ghayouri L, Tsai S, Geelhoed M, Rettig MB. Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e227852. doi: 10.1001/jamanetworkopen.2022.7852.

  PMID: 35438754 RESULT

• Nickols NG, Goetz MB, Graber CJ, Bhattacharya D, Soo Hoo G, Might M, Goldstein DB, Wang X, Ramoni R, Myrie K, Tran S, Ghayouri L, Tsai S, Geelhoed M, Makarov D, Becker DJ, Tsay JC, Diamond M, George A, Al-Ajam M, Belligund P, Montgomery RB, Mostaghel EA, Sulpizio C, Mi Z, Dematt E, Tadalan J, Norman LE, Briones D, Clise CE, Taylor ZW, Huminik JR, Biswas K, Rettig MB. Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial. Trials. 2021 Jul 5;22(1):431. doi: 10.1186/s13063-021-05389-0.

  PMID: 34225789 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Matthew Rettig
• Organization: Department of Veterans Affairs GLA

matthew.rettig@va.gov

310-478-3711

Study Officials

• Matthew B. Rettig, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 21, 2020
• Study Start: July 6, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)