Public Health Response to SARS-CoV-2 in Assisted Living Facilities in New York State: March 2020-December 2022.

CONTEXT: Assisted living facility (ALF) residents are especially vulnerable to SARS-CoV-2 infection due to the age and comorbidities of the resident population and the social nature of these facilities. OBJECTIVE: To collate all New York State Department of Health guidance and regulations to control transmission of SARS-CoV-2 infection within ALFs from March 2020 through December 2022 and to include US Food and Drug Administration COVID-19 testing and vaccine authorizations. DESIGN: A narrative chronological review of all New York State Department of Health guidance. RESULTS: Documents and associated guidance and regulations are divided into 4 sections: (1) lockdown until COVID-19 vaccine emergency use authorization; (2) COVID-19 vaccine authorization until phased reopening; (3) phased reopening, vaccination requirements, and booster vaccination; (4) the period of the bivalent booster. CONCLUSION: Controlling the spread of SARS-CoV-2 within ALFs required a multifactorial approach that included stringent infection control measures, testing, and vaccination and careful attention to the social structure and support systems within ALFs. The SARS-CoV-2 pandemic highlighted the complexity of controlling spread of an easily transmissible respiratory pathogen in assisted living communities and the need to structure infection control programs within the diverse ALFs that provide care for our aging population.

Sequential Phase II clinical trials evaluating CRLX101 as monotherapy and in combination with bevacizumab in recurrent ovarian cancer.

BACKGROUND: Topoisomerase-1 inhibitors are an important class of cytotoxics associated with toxicity that limits their use. CRLX101 is a novel cyclodextrin-containing polymer conjugate of camptothecin (CPT) that self-assembles into nanoparticles to deliver sustained levels of active CPT into cancer cells while substantially reducing systemic exposure. METHODS: We conducted sequential phase II, open label, single arm clinical trials to evaluate CRLX101 as a single agent (n = 29) and with bevacizumab (Bev) (n = 34). Patients (pts) had measurable recurrent epithelial ovarian, tubal or primary peritoneal cancer, that could be platinum refractory, resistant or sensitive. Cohort A (Single agent CRLX101) allowed up to 3 prior chemotherapy regimens, but no prior topo-1 inhibitors. Pts received CRLX101 15 mg/m2 IV every 14 days Q28 with response evaluation every 2 cycles. Cohort B also received Bev 10 mg/kg D1,15 Q28, and included only platinum resistant disease with up to 2 prior lines, and more rigorous eligibility criteria. RESULTS: CRLX101 was well tolerated other than nausea, fatigue and anemia. 29 pts. received a median of 3 (1-16) cycles with a clinical benefit rate (CBR) of 68% and overall response rate (ORR) of 11%. With the addition of Bev in Cohort B (n = 34), the CBR was increased to 95% and the ORR to 18%. PFS was 4.5 months (0.9 to 15.9 months) in Cohort A and 6.5 months (2.8 to 14.4 months) in Cohort B. Bev increased the incidence of hypertension and qualitatively increased bladder toxicities, but without SAEs. CONCLUSIONS: CRLX101 meets the clinical need for an effective and tolerable topoisomerase I inhibitor and can be safely combined with bevacizumab.