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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT04397718
• Collaborator: (none)
• Enrollment: 96
• Locations: 14
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Degarelix; Other: Saline	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH): A Multicenter, Phase 2 Randomized Controlled Trial of Best Supportive Care (BSC) vs BSC Plus Degarelix
• Actual Study Start Date: Jul 6, 2020
• Actual Primary Completion Date: Jun 8, 2021
• Actual Study Completion Date: Jun 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo + BSC No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.	Other: Saline; 09% Saline
Experimental: Degarelix + BSC 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

Outcome Measures

Primary Outcome Measures

1. Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15 [15 days]

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

Secondary Outcome Measures

1. Time to Clinical Improvement [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   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.

2. Inpatient Mortality [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   Number of patients who died during their hospital stay

3. Duration of Hospitalization [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   Length of hospital stay (randomization to discharge)

4. Duration of Intubation [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   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.

5. Time to Normalization of Temperature. [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   Length of time for temperature to be less than < 37.5 degree Celsius for 48 hours

6. Maximum Severity of COVID19 Illness. [Through discharge (an average of 8 days with a maximum of 2.5 months)]

   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.

7. Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30 [30 days]

   Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

1. at the time of randomization.

• The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.

Exclusion Criteria:

• 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:

1. Androgen receptor antagonists or agonists within 4 weeks,

2. Ketoconazole or abiraterone acetate within 2 weeks,

3. Estrogens or progestins within 2 weeks,

4. Herbal products that contain hormonally active agents within 2 weeks.

• Unwilling or unable to comply with the study protocol.

• Any condition, which in the opinion of the investigator, would preclude participation in the trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix VA Health Care System, Phoenix, AZ	Phoenix	Arizona	United States	85012
2	Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR	Little Rock	Arkansas	United States	72205-5484
3	VA Long Beach Healthcare System, Long Beach, CA	Long Beach	California	United States	90822
4	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	Los Angeles	California	United States	90073
5	Miami VA Healthcare System, Miami, FL	Miami	Florida	United States	33125
6	St. Louis VA Medical Center John Cochran Division, St. Louis, MO	Saint Louis	Missouri	United States	63106
7	Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY	Brooklyn	New York	United States	11209
8	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York	United States	10010
9	Philadelphia MultiService Center, Philadelphia, PA	Philadelphia	Pennsylvania	United States	19106
10	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina	United States	29401-5799
11	Memphis VA Medical Center, Memphis, TN	Memphis	Tennessee	United States	38104
12	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas	United States	75216
13	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030
14	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Matthew B. Rettig, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

• Study Protocol - Feb 9, 2021
• Statistical Analysis Plan - Aug 5, 2021

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04397718
• Other Study ID Numbers: COVID19-8900-15
• First Posted: May 21, 2020
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• 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
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Period Title: Overall Study
STARTED	34	62
COMPLETED	27	47
NOT COMPLETED	7	15

Baseline Characteristics

Arm/Group Title	Placebo + BSC	Degarelix + BSC	Total
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer	Total of all reporting groups
Overall Participants	34	62	96
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.1 (8.18)	68.8 (8.6)	68.5 (8.42)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	34 100%	62 100%	96 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.9%	12 19.4%	14 14.6%
Not Hispanic or Latino	32 94.1%	48 77.4%	80 83.3%
Unknown or Not Reported	0 0%	2 3.2%	2 2.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1.6%	1 1%
Asian	0 0%	2 3.2%	2 2.1%
Native Hawaiian or Other Pacific Islander	0 0%	1 1.6%	1 1%
Black or African American	15 44.1%	23 37.1%	38 39.6%
White	17 50%	28 45.2%	45 46.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 5.9%	7 11.3%	9 9.4%

Outcome Measures

1. Primary Outcome

Title	Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
Description	Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
Time Frame	15 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	34	62
Count of Participants [Participants]	9 26.5%	19 30.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.667
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.46 to 3.06
	Parameter Dispersion	Type: Value:
	Estimation Comments	Logistic regression adjusted for age, hypertension, and COPD

2. Secondary Outcome

Title	Time to Clinical Improvement
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	34	62
Median (Inter-Quartile Range) [Days]	5.50	7.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.876
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.58 to 1.49
	Parameter Dispersion	Type: Value:
	Estimation Comments	Cox regression model adjusted for age, hypertension, and COPD.

3. Secondary Outcome

Title	Inpatient Mortality
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	34	62
Count of Participants [Participants]	6 17.6%	11 17.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.991
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.31 to 2.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	Logistic regression adjusted for age, hypertension, and COPD.

4. Secondary Outcome

Title	Duration of Hospitalization
Description	Length of hospital stay (randomization to discharge)
Time Frame	Through discharge (an average of 8 days with a maximum of 2.5 months)

Outcome Measure Data

Analysis Population Description

Patients who died during the hospital stay were excluded.

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	28	51
Median (Inter-Quartile Range) [Days]	5.00	6.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.841
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Quantile Regression
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -2.03 to 4.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted for age, hypertension, and COPD

5. Secondary Outcome

Title	Duration of Intubation
Description	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)

Outcome Measure Data

Analysis Population Description

Patients who died and who were not on mechanical ventilation prior to death were excluded (N=4).

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	33	59
Median (Inter-Quartile Range) [Days]	0.00	0.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.746
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Quantile Regression
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; 0 to 0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted for age, hypertension, and COPD

6. Secondary Outcome

Title	Time to Normalization of Temperature.
Description	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)

Outcome Measure Data

Analysis Population Description

Patients with a fever (temperature greater than or equal to 37.5 degrees Celsius) at baseline.

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	7	17
Median (Inter-Quartile Range) [Days]	5.00	3.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.72 to 7.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	Cox regression model adjusted for age, hypertension, and COPD

7. Secondary Outcome

Title	Maximum Severity of COVID19 Illness.
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	34	62
Hospitalization, not requiring supplemental oxygen	4 11.8%	8 12.9%
Hospitalization, requiring supplemental oxygen	20 58.8%	26 41.9%
Hospitalization,req. nasal high-flow oxygen therapy &/or noninvasive mechanical ventilation	4 11.8%	14 22.6%
Hospitalization, req. extracorporeal membrane oxygenation &/or invasive mech. ventilation	0 0%	3 4.8%
Death	6 17.6%	11 17.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.425
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.33 to 2
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.

8. Secondary Outcome

Title	Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30
Description	Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo + BSC	Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline	Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
Measure Participants	34	62
Count of Participants [Participants]	7 20.6%	15 24.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo + BSC, Degarelix + BSC
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.688
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; 0.44 to 3.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	Logistic regression adjusted for age, hypertension, and COPD.

Adverse Events

Time Frame	From randomization through day 60.
Adverse Event Reporting Description	AE and SAE data were collected through spontaneous local SC/LSI/Co-I contact, during in-person study visits, and gathered during telephone contacts and medical record reviews when performed.
Arm/Group Title	Placebo + BSC		Degarelix + BSC
Arm/Group Description	No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline		Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer
All Cause Mortality
	Placebo + BSC		Degarelix + BSC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/34 (20.6%)		11/62 (17.7%)
Serious Adverse Events
	Placebo + BSC		Degarelix + BSC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/34 (32.4%)		19/62 (30.6%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/34 (0%)	0	1/62 (1.6%)	1
Leukocytosis	0/34 (0%)	0	1/62 (1.6%)	1
Cardiac disorders
Supraventricular tachycardia	0/34 (0%)	0	1/62 (1.6%)	1
Gastrointestinal disorders
Diarrhoea	0/34 (0%)	0	1/62 (1.6%)	1
Infections and infestations
COVID-19	0/34 (0%)	0	3/62 (4.8%)	3
COVID-19 pneumonia	4/34 (11.8%)	4	5/62 (8.1%)	5
Gastroenteritis	1/34 (2.9%)	1	0/62 (0%)	0
SARS-CoV-2 sepsis	0/34 (0%)	0	1/62 (1.6%)	1
Septic shock	0/34 (0%)	0	4/62 (6.5%)	4
Metabolism and nutrition disorders
Hyperglycaemia	0/34 (0%)	0	1/62 (1.6%)	1
Renal and urinary disorders
Acute kidney injury	1/34 (2.9%)	1	1/62 (1.6%)	1
Chronic kidney disease	0/34 (0%)	0	1/62 (1.6%)	1
Renal failure	0/34 (0%)	0	2/62 (3.2%)	2
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/34 (0%)	0	1/62 (1.6%)	1
Dyspnoea	1/34 (2.9%)	1	1/62 (1.6%)	1
Pleuritic pain	0/34 (0%)	0	1/62 (1.6%)	1
Pneumomediastinum	0/34 (0%)	0	1/62 (1.6%)	1
Pulmonary embolism	0/34 (0%)	0	1/62 (1.6%)	1
Respiratory failure	4/34 (11.8%)	4	3/62 (4.8%)	3
Vascular disorders
Mouth haemorrhage	1/34 (2.9%)	1	0/62 (0%)	0
Orthostatic hypotension	1/34 (2.9%)	1	0/62 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo + BSC		Degarelix + BSC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/34 (23.5%)		13/62 (21%)
Cardiac disorders
Accelerated idioventricular rhythm	1/34 (2.9%)	1	0/62 (0%)	0
Arrhythmia	0/34 (0%)	0	1/62 (1.6%)	1
Atrial fibrillation	2/34 (5.9%)	2	1/62 (1.6%)	1
Gastrointestinal disorders
Abdominal pain	0/34 (0%)	0	1/62 (1.6%)	1
Constipation	0/34 (0%)	0	1/62 (1.6%)	1
Diarrhoea	0/34 (0%)	0	1/62 (1.6%)	1
Nausea	0/34 (0%)	0	2/62 (3.2%)	2
General disorders
Fatigue	0/34 (0%)	0	1/62 (1.6%)	1
Peripheral swelling	1/34 (2.9%)	1	0/62 (0%)	0
Pyrexia	0/34 (0%)	0	1/62 (1.6%)	1
Infections and infestations
Bacteraemia	1/34 (2.9%)	1	0/62 (0%)	0
Urinary tract infection	1/34 (2.9%)	1	1/62 (1.6%)	1
Injury, poisoning and procedural complications
Injection site pain	0/34 (0%)	0	1/62 (1.6%)	1
Injection site reaction	0/34 (0%)	0	1/62 (1.6%)	1
Tooth avulsion	1/34 (2.9%)	1	0/62 (0%)	0
Metabolism and nutrition disorders
Hyperglycaemia	1/34 (2.9%)	1	0/62 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in extremity	1/34 (2.9%)	1	0/62 (0%)	0
Nervous system disorders
Seizure	0/34 (0%)	0	1/62 (1.6%)	1
Syncope	1/34 (2.9%)	1	0/62 (0%)	0
Reproductive system and breast disorders
Erectile dysfunction	0/34 (0%)	0	1/62 (1.6%)	1
Gynaecomastia	1/34 (2.9%)	1	0/62 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/34 (2.9%)	1	0/62 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/34 (0%)	0	1/62 (1.6%)	2
Vascular disorders
Hot flush	0/34 (0%)	0	3/62 (4.8%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.