Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial.

Importance: SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. Objective: To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. Design, Setting, and Participants: The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021. Interventions: Patients stratified by age, history of hypertension, and disease severity were centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo. Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone. Main Outcomes and Measures: The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. Secondary end points were time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference range, maximum severity of COVID-19, and the composite end point at 30 days. Results: The trial was stopped for futility after the planned interim analysis, at which time there were 96 evaluable patients, including 62 patients randomized to the degarelix group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns. Conclusions and Relevance: In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. Trial Registration: ClinicalTrials.gov Identifier: NCT04397718.

Characteristics and Outcomes of Infectious Diseases Electronic COVID-19 Consultations at a Multisite Academic Health System.

Objective The need for clinicians to access Infectious Diseases (ID) consultants for clinical decision-making support increased during the Coronavirus Disease 2019 (COVID-19) pandemic. Traditional ID consultations with face-to-face (FTF) patient assessments are not always possible or practical during a pandemic and involve added exposure risk and personal protective equipment (PPE) use. Electronic consultations (e-consults) may provide an alternative and improve access to ID specialists during the pandemic. Methods We implemented ID e-consult platforms designed to answer clinical questions related to COVID-19 at three academic clinical institutions in Dallas, Texas. We conducted a retrospective review of all COVID-19 ID e-consults between March 16, 2020 and May 15, 2020 evaluating characteristics and outcomes of e-consults among the clinical sites. Results We completed 198 COVID-19 ID e-consults at participating institutions. The most common e-consult indications were for 63 (32%) repeat testing, 61 (31%) initial testing, 65 (33%) treatment options, and 61 (31%) Infection Prevention (IP). Based on the e-consult recommendation, 53 (27%) of patients were initially tested for COVID-19, 45 (23%) were re-tested, 44 (22%) of patients had PPE precautions initiated, and 37 (19%) had PPE precautions removed. The median time to consult completion was four hours and 8 (4%) consults were converted to standard FTF consults. Conclusion E-consult services can provide safe and timely access to ID specialists during the COVID-19 pandemic, minimizing the risk of infection to the patient and health care workers, while preserving PPE and testing supplies.