A Phase 2 interventional study of Degarelix and Saline in COVID-19, sponsored by VA Office of Research and Development. Completed at 14 sites in United States. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
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.
A novel coronavirus, now termed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), arose late in 2019. The first confirmed cases occurred in December in Wuhan, Hubei province, China. It now infects people on six continents, spreading person to person. The World Health Organization (WHO) classified it as a global pandemic on March 11, 2020. As of April 6, 2020, there are more than 1.2 million confirmed cases and more than 70,000 deaths attributed to this virus. Every person on Earth, as well as every United States Veteran, is at risk. This is the emergent public health threat of our time.
SARS-CoV-2 is a singled stranded RNA virus related to severe acute respiratory syndrome-related coronavirus (SARS-CoV-1). SARS-CoV-2 is thought to be transmissible largely by respiratory droplets or direct contact, but might also be transmitted through aerosolization. SARS-CoV-2 disease severity ranges from no to minimal symptoms, mildly symptomatic with cough and dyspnea, to severe respiratory distress with multi-organ failure requiring admission to an intensive care unit and emergent ventilator support. Although data are evolving, the severity of illness varies with age, co-existing comorbidities, and biological sex, with older age, people with pre-existing cardiovascular disease, and males manifesting greater disease severity.
A worldwide effort is in place to contain and suppress human-to-human transmission. These public-health strategies aim to slow the rate of spread and reduce the burden on critical care infrastructure. However, there is also a need effective therapeutics. Vaccine trials are underway but potential approvals are at least a year away. Development of new drugs de novo to treat SARS2-CoV-2 will likely take even longer. Thus, the most expedient therapeutic strategy to confront this pandemic will repurpose existing FDA-approved therapeutics. One potential strategy targets viral components directly, using existing antivirals and anti-infectives currently used for other diseases. Such efforts include trials of hydroxychloroquine, remdesivir, and ribavirin. Another strategy involves targeting the human proteins, rather than viral proteins, required for SARS CoV-2 entry and replication.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 96 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Use of any of the following hormonal agents within Day 1 of treatment:
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Other: Saline
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Drug: Degarelix
Degarelix is an FDA-approved drug for prostate cancer
09% Saline
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.
Time frame: 15 days
Time to Clinical Improvement
Time to clinical improvement as defined by a decline of 2 categories or more from the baseline modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge, whichever comes first. Participants whose condition worsened, who died, or who withdrew from the study without clinical improvement were censored. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Inpatient Mortality
Number of patients who died during their hospital stay
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Duration of Hospitalization
Length of hospital stay (randomization to discharge)
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Duration of Intubation
Length of time on mechanical ventilation. Length of mechanical ventilation imputed to maximum length (50 days) for patients who died on mechanical ventilation or who were on mechanical ventilation, but date removed was unknown. Length of mechanical ventilation imputed to 0 for patients never on mechanical ventilation.
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Time to Normalization of Temperature.
Length of time for temperature to be less than \< 37.5 degree Celsius for 48 hours
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Maximum Severity of COVID19 Illness.
Maximum severity score on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
Time frame: Through discharge (an average of 8 days with a maximum of 2.5 months)
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
Time frame: 30 days
| Milestone | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Started | 34 | 62 |
| Completed | 27 | 47 |
| Not completed | 7 | 15 |
| Withdrew: Death | 7 | 11 |
| Withdrew: Lost to follow-up | 0 | 4 |
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
| Participants | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15 | 9 | 19 |
Time to clinical improvement as defined by a decline of 2 categories or more from the baseline modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge, whichever comes first. Participants whose condition worsened, who died, or who withdrew from the study without clinical improvement were censored. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
| Days | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Time to Clinical Improvement | 5.50 (5 to 15) | 7.00 (4 to 15) |
Number of patients who died during their hospital stay
| Participants | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Inpatient Mortality | 6 | 11 |
Length of hospital stay (randomization to discharge)
| Days | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Duration of Hospitalization | 5.00 (5 to 8) | 6.00 (3 to 9) |
Length of time on mechanical ventilation. Length of mechanical ventilation imputed to maximum length (50 days) for patients who died on mechanical ventilation or who were on mechanical ventilation, but date removed was unknown. Length of mechanical ventilation imputed to 0 for patients never on mechanical ventilation.
| Days | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Duration of Intubation | 0.00 (0 to 0) | 0.00 (0 to 0) |
Length of time for temperature to be less than \< 37.5 degree Celsius for 48 hours
| Days | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Time to Normalization of Temperature. | 5.00 (2 to 18) | 3.00 (1 to 3) |
Maximum severity score on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.
| Participants | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Hospitalization, not requiring supplemental oxygen | 4 | 8 |
| Hospitalization, requiring supplemental oxygen | 20 | 26 |
| Hospitalization,req. nasal high-flow oxygen therapy &/or noninvasive mechanical ventilation | 4 | 14 |
| Hospitalization, req. extracorporeal membrane oxygenation &/or invasive mech. ventilation | 0 | 3 |
| Death | 6 | 11 |
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
| Participants | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30 | 7 | 15 |
Collected over From randomization through day 60.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + BSC | 7/34 (20.6%) | 11/34 (32.4%) | 8/34 (23.5%) |
| Degarelix + BSC | 11/62 (17.7%) | 19/62 (30.6%) | 13/62 (21%) |
| Event | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 4/34 | 5/62 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/34 | 3/62 |
| Septic shockInfections and infestations | 0/34 | 4/62 |
| COVID-19Infections and infestations | 0/34 | 3/62 |
| Renal failureRenal and urinary disorders | 0/34 | 2/62 |
| GastroenteritisInfections and infestations | 1/34 | 0/62 |
| Acute kidney injuryRenal and urinary disorders | 1/34 | 1/62 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/34 | 1/62 |
| Mouth haemorrhageVascular disorders | 1/34 | 0/62 |
| Orthostatic hypotensionVascular disorders | 1/34 | 0/62 |
| Event | Placebo + BSC | Degarelix + BSC |
|---|---|---|
| Atrial fibrillationCardiac disorders | 2/34 | 1/62 |
| Hot flushVascular disorders | 0/34 | 3/62 |
| NauseaGastrointestinal disorders | 0/34 | 2/62 |
| Accelerated idioventricular rhythmCardiac disorders | 1/34 | 0/62 |
| Peripheral swellingGeneral disorders | 1/34 | 0/62 |
| BacteraemiaInfections and infestations | 1/34 | 0/62 |
| Urinary tract infectionInfections and infestations | 1/34 | 1/62 |
| Tooth avulsionInjury, poisoning and procedural complications | 1/34 | 0/62 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/34 | 0/62 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/34 | 0/62 |
| Age, Continuous(years) | Placebo + BSC | Degarelix + BSC | Total |
|---|---|---|---|
| Mean | 68.1 ± 8.18 | 68.8 ± 8.6 | 68.5 ± 8.42 |
| Sex: Female, Male(Participants) | Placebo + BSC | Degarelix + BSC | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 34 | 62 | 96 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + BSC | Degarelix + BSC | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 12 | 14 |
| Not Hispanic or Latino | 32 | 48 | 80 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Placebo + BSC | Degarelix + BSC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 15 | 23 | 38 |
| White | 17 | 28 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 7 | 9 |
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