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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 14
- 主要终点
- Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
- •Unwilling or unable to comply with the study protocol.
- •Any condition, which in the opinion of the investigator, would preclude participation in the trial.
研究组 & 干预措施
Placebo + BSC
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
干预措施: Saline (Other)
Degarelix + BSC
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
干预措施: Degarelix (Drug)
结局指标
主要结局
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
时间窗: 15 days
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
次要结局
- Inpatient Mortality(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))
- Time to Clinical Improvement(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))
- Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30(30 days)
- Duration of Intubation(Through discharge (an average of 8 days with a maximum of 2.5 months))
- Maximum Severity of COVID19 Illness.(Through discharge (an average of 8 days with a maximum of 2.5 months))