Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial.

Background The entry of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) into type II pneumocytes is dependent on a modification of viral spike proteins by transmembrane protease serine 2 (TMPRSS2) expressed on the surface of human cells. TMPRSS2 is regulated by the androgen receptor, hence, SARS-CoV-2 infectivity is indirectly dependent on androgenic status and phenotype. Previously, we have reported that men affected by androgenetic alopecia (AGA) are overrepresented in severe coronavirus disease 2019 (COVID-19). Additionally, we have reported that men taking antiandrogenic drugs, e.g., 5-alpha-reductase inhibitors (5ARis), are less likely to have severe COVID-19. Here we aimed to test whether the androgen receptor antagonist, Proxalutamide, would be a beneficial treatment for subjects with SARS-CoV-2 infection. Methods Male and female subjects were recruited to a double-blinded, randomized, prospective, investigational study of Proxalutamide for the treatment of COVID-19. Mild to moderate, non-hospitalized subjects, who were confirmed positive for SARS-CoV-2, were treated with either Proxalutamide 200 mg/day or placebo. Endpoints for the study were remission time (days) and the percentage of subjects confirmed negative for SARS-CoV-2 on Day 7 after treatment. A negative SARS-CoV-2 test was defined by concentration-time (Ct)>40 determined by real-time reverse transcription-polymerase chain reaction (rtPCR). Results Two-hundred thirty-six (2360 subjects were included in the study (108 female, 128 male); 171 were randomized to the Proxalutamide arm and 65 were in the placebo group. On Day 7, SARS-CoV-2 became non-detectable with rtPCR (cT>40) in 82% of the subjects in the Proxalutamide group versus 31% in the placebo group (p < 0.001). The average clinical remission time for patients treated with Proxalutamide was 4.2 ±5.4 days versus 21.8 ±13.0 days in the placebo arm (p < 0.001). Conclusion Proxalutamide significantly accelerated viral clearance on Day 7 in mild to moderate COVID-19 patients versus placebo. Further, the time to clinical remission was significantly reduced in patients treated with Proxalutamide versus placebo.

Italian Survey for the Evaluation of the Effects of Coronavirus Disease 2019 (COVID-19) Pandemic on Alopecia Areata Recurrence.

INTRODUCTION: The inflammation storm involved in coronavirus disease 2019 (COVID-19) infection and worsening and the psychological stress derived from current quarantine conditions can affect the course of many skin and scalp conditions. This study examined the possible effects of COVID-19 on alopecia areata (AA) relapse in patients suffering from these scalp conditions during the pandemic. METHODS: The study was carried out in the form of an observational cross-sectional type using a questionnaire sent by mail to a cohort of patients affected by AA during the pandemic from March 2020 to October 2020. RESULTS: During the pandemic, AA relapse was reported in 42.5% of the participants who also declared COVID-19 infection, confirmed by nasopharyngeal swab or hematological analysis. The relapse was reported about 2 months later COVID-19 infection (median of 2.14 months) and 74.0% of these participants continue to experience AA symptoms when the survey was proposed. Only 12.5% of participants reported AA relapse in the absence of COVID-19 infection. CONCLUSIONS: The present study reported a significant relapse in patients suffering from AA and infected by COVID-19. This phenomenon could be attributed to the inflammation storm typical of COVID-19 infection and the psychological stress derived from quarantine conditions.

Evaluation of the alopecia areata patients on tofacitinib treatment during the COVID-19 pandemic.

Tofacitinib is a Janus Kinase 3 inhibitor that is used in the treatment of alopecia areata. We recommended our alopecia areata patients to discontinue their tofacitinib treatment during the COVID-19 pandemic for an average of 80 days. We aimed to evaluate the drug use and the SARS-CoV-2 infection status of alopecia areata patients; and the relationships of recurrence to age, gender, treatment duration, and tofacitinib discontinuation. One-hundred and ninety-one (61.4%) patients were off the drug and 120 (38.6%) were on therapy during the pandemic. The relationship between drug discontinuation due to the COVID-19 pandemic and recurrence was statistically significant (P < .001). Statistically significant relationships of age (P = .013) and treatment duration (P < .001) to recurrence were also found. The change in the SALT score differed between the patients on therapy and off therapy during the pandemic (P < .001). A significant negative correlation was found between the change in the SALT score and treatment duration: the spearman correlation test P = .018. We concluded that the patients may continue to the tofacitinib therapy during the rest of the COVID-19 pandemic if the benefit outweighed the risk.

The impact of individual lifestyle and status on the acquisition of COVID-19: A case-Control study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has spread to the world. Whether there is an association between lifestyle behaviors and the acquisition of COVID-19 remains unclear. METHODS: In this case-control study, we recruited 105 patients with SARS-CoV-2 infection as a case group from the Wuhan Tongji Hospital (Wuhan, China). For each case two control subjects were recruited. Participants were randomly selected from communities in Wuhan and matched for sex, age (± 2yrs), and pre-existing comorbidities (hypertension and diabetes). RESULTS: A total of 105 patients diagnosed with COVID-19 and 210 controls were included. Compared with control group, the case group had higher proportions of lack of sleep (30.5% vs. 14.8%, P = 0.001) and increased physical activities (56.2% vs. 32.9%, P < 0.001). And patients in the case group were more likely to have alopecia (28.6% vs. 10.0%, P < 0.001) than people from the control group. Overall, we found that lack of sleep [adjusted odds ratio (OR) 1.56, 95% confidence interval (CI) 1.03-2.39)], physical activities (≥ 5 times a week) (adjusted OR 2.05, 95%CI 1.39-3.02) and alopecia (adjusted OR 1.73, 95%CI 1.13-2.66) were independent risk factors for COVID-19 infection. Conversely, low-dose alcohol intake (<100g alcohol per week), hand hygiene, and fruits intake (daily) were significantly associated with a decrease in morbidity. CONCLUSIONS: Individual lifestyle behaviors and health status can affect the occurrence of COVID-19.

Cutaneous Manifestations of COVID-19: A Report from the United Arab Emirates.

Coronavirus disease of 2019 (COVID-19) is a viral infection caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). In addition to affecting mainly the respiratory tract, there have been many reported cutaneous manifestations of the disease. A retrospective case series based on history and clinical findings was performed across six hospitals in the UAE, including two field hospitals. A total of 324 patients with COVID-19 were identified and divided into three groups based on the severity of the disease. Forty-five (12.5%) patients had clearly identifiable cutaneous manifestation of COVID-19. Two patients each with alopecia areata and sclerosis of the extremities, respectively, were identified in the second group. Cutaneous manifestations of COVID-19 have been well reported across the literature. The experience in the UAE is similar to that of published reports. The occurrence of other cutaneous manifestations with an underlying autoimmune pathogenesis should raise the possibility of such conditions in those with COVID-19. (SKINmed. 2020;18:218-220).

A preliminary observation: Male pattern hair loss among hospitalized COVID-19 patients in Spain - A potential clue to the role of androgens in COVID-19 severity.

A preliminary observation of high frequency of male pattern hair loss among admitted COVID-19 patients and suggest that androgen expression might be a clue to COVID-19 severity.