Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial.

OBJECTIVE: We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19. DESIGN: Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Endpoints were time to (primary) or rate of (secondary) symptom resolution, and resolution of inflammation (exploratory). RESULTS: Of 55 patients in the intention-to-treat group (median age 35 years (IQR: 20); 35 women (64%); 18 African American (33%); 14 Hispanic (26%)), 52 (95%) completed the trial, submitting 1358 electronic symptom surveys. Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms. CONCLUSIONS: Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required.

Factors associated with COVID-19 vaccine receipt at two integrated healthcare systems in New York City: a cross-sectional study of healthcare workers.

OBJECTIVES: To examine the factors associated with COVID-19 vaccine receipt among healthcare workers and the role of vaccine confidence in decisions to vaccinate, and to better understand concerns related to COVID-19 vaccination. DESIGN: Cross-sectional anonymous survey among front-line, support service and administrative healthcare workers. SETTING: Two large integrated healthcare systems (one private and one public) in New York City during the initial roll-out of the COVID-19 vaccine. PARTICIPANTS: 1933 healthcare workers, including nurses, physicians, allied health professionals, environmental services staff, researchers and administrative staff. PRIMARY OUTCOME MEASURES: The primary outcome was COVID-19 vaccine receipt during the initial roll-out of the vaccine among healthcare workers. RESULTS: Among 1933 healthcare workers who had been offered the vaccine, 81% had received the vaccine at the time of the survey. Receipt was lower among black (58%; OR: 0.14, 95% CI 0.1 to 0.2) compared with white (91%) healthcare workers, and higher among non-Hispanic (84%) compared with Hispanic (69%; OR: 2.37, 95% CI 1.8 to 3.1) healthcare workers. Among healthcare workers with concerns about COVID-19 vaccine safety, 65% received the vaccine. Among healthcare workers who agreed with the statement that the vaccine is important to protect family members, 86% were vaccinated. Of those who disagreed, 25% received the vaccine (p<0.001). In a multivariable analysis, concern about being experimented on (OR: 0.44, 95% CI 0.31 to 0.6), concern about COVID-19 vaccine safety (OR: 0.39, 95% CI 0.28 to 0.55), lack of influenza vaccine receipt (OR: 0.28, 95% CI 0.18 to 0.44), disagreeing that COVID-19 vaccination is important to protect others (OR: 0.37, 95% CI 0.27 to 0.52) and black race (OR: 0.38, 95% CI 0.24 to 0.59) were independently associated with COVID-19 vaccine non-receipt. Over 70% of all healthcare workers responded that they had been approached for vaccine advice multiple times by family, community members and patients. CONCLUSIONS: Our data demonstrated high overall receipt among healthcare workers. Even among healthcare workers with concerns about COVID-19 vaccine safety, side effects or being experimented on, over 50% received the vaccine. Attitudes around the importance of COVID-19 vaccination to protect others played a large role in healthcare workers' decisions to vaccinate. We observed striking inequities in COVID-19 vaccine receipt, particularly affecting black and Hispanic workers. Further research is urgently needed to address issues related to vaccine equity and uptake in the context of systemic racism and barriers to care. This is particularly important given the influence healthcare workers have in vaccine decision-making conversations in their communities.

Long-Term Air Pollution Exposure and COVID-19 Mortality: A Patient-Level Analysis from New York City.

Rationale: Risk factors for coronavirus disease (COVID-19) mortality may include environmental exposures such as air pollution. Objectives: To determine whether, among adults hospitalized with PCR-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), long-term air pollution exposure is associated with the risk of mortality, ICU admission, or intubation. Methods: We performed a retrospective analysis of SARS-CoV-2 PCR-positive patients admitted to seven New York City hospitals from March 8, 2020, to August 30, 2020. The primary outcome was mortality; secondary outcomes were ICU admission and intubation. We estimated the annual average fine particulate matter (particulate matter ⩽2.5 µm in aerodynamic diameter [PM2.5]), nitrogen dioxide (NO2), and black carbon (BC) concentrations at patients' residential address. We employed double robust Poisson regression to analyze associations between the annual average PM2.5, NO2, and BC exposure level and COVID-19 outcomes, adjusting for age, sex, race or ethnicity, hospital, insurance, and the time from the onset of the pandemic. Results: Among the 6,542 patients, 41% were female and the median age was 65 (interquartile range, 53-77) years. Over 50% self-identified as a person of color (n = 1,687 [26%] Hispanic patients; n = 1,659 [25%] Black patients). Air pollution exposure levels were generally low. Overall, 31% (n = 2,044) of the cohort died, 19% (n = 1,237) were admitted to the ICU, and 16% (n = 1,051) were intubated. In multivariable models, a higher level of long-term exposure to PM2.5 was associated with an increased risk of mortality (risk ratio, 1.11 [95% confidence interval, 1.02-1.21] per 1-µg/m3 increase in PM2.5) and ICU admission (risk ratio, 1.13 [95% confidence interval, 1.00-1.28] per 1-µg/m3 increase in PM2.5). In multivariable models, neither NO2 nor BC exposure was associated with COVID-19 mortality, ICU admission, or intubation. Conclusions: Among patients hospitalized with COVID-19, a higher long-term PM2.5 exposure level was associated with an increased risk of mortality and ICU admission.

Cross-sectional study evaluating the seroprevalence of SARS-CoV-2 antibodies among healthcare workers and factors associated with exposure during the first wave of the COVID-19 pandemic in New York.

OBJECTIVE: Estimate the seroprevalence of SARS-CoV-2 antibodies among New York City Health and Hospitals (NYC H+H) healthcare workers during the first wave of the COVID-19 pandemic, and describe demographic and occupational factors associated with SARS-CoV-2 antibodies among healthcare workers. DESIGN: Descriptive, observational, cross-sectional study using a convenience sample of data from SARS-CoV-2 serological tests accompanied by a demographic and occupational survey administered to healthcare workers. SETTING: A large, urban public healthcare system in NYC. PARTICIPANTS: Participants were employed by NYC H+H and either completed serological testing at NYC H+H between 30 April 2020 and 30 June 2020, or completed SARS-CoV-2 antibody testing outside of NYC H+H and were able to self-report results from the same time period. PRIMARY OUTCOME MEASURE: SARS-CoV-2 serostatus, stratified by key demographic and occupational characteristics reported through the demographic and occupational survey. RESULTS: Seven hundred and twenty-seven survey respondents were included in analysis. Participants had a mean age of 46 years (SD=12.19) and 543 (75%) were women. Two hundred and fourteen (29%) participants tested positive or reported testing positive for the presence of SARS-CoV-2 antibodies (IgG+). Characteristics associated with positive SARS-CoV-2 serostatus were Black race (25% IgG +vs 15% IgG-, p=0.001), having someone in the household with COVID-19 symptoms (49% IgG +vs 21% IgG-, p<0.001), or having a confirmed COVID-19 case in the household (25% IgG +vs 5% IgG-, p<0.001). Characteristics associated with negative SARS-CoV-2 serostatus included working on a COVID-19 patient floor (27% IgG +vs 36% IgG-, p=0.02), working in the intensive care unit (20% IgG +vs 28% IgG-, p=0.03), being employed in a clinical occupation (64% IgG +vs 78% IgG-, p<0.001) or having close contact with a patient with COVID-19 (51% IgG +vs 62% IgG-, p=0.03). CONCLUSIONS: Results underscore the significance that community factors and inequities might have on SARS-CoV-2 exposure for healthcare workers.

DRUL for school: Opening Pre-K with safe, simple, sensitive saliva testing for SARS-CoV-2.

To address the need for simple, safe, sensitive, and scalable SARS-CoV-2 tests, we validated and implemented a PCR test that uses a saliva collection kit use at home. Individuals self-collected 300 µl saliva in vials containing Darnell Rockefeller University Laboratory (DRUL) buffer and extracted RNA was assayed by RT-PCR (the DRUL saliva assay). The limit of detection was confirmed to be 1 viral copy/µl in 20 of 20 replicate extractions. Viral RNA was stable in DRUL buffer at room temperature up to seven days after sample collection, and safety studies demonstrated that DRUL buffer immediately inactivated virus at concentrations up to 2.75x106 PFU/ml. Results from SARS-CoV-2 positive nasopharyngeal (NP) swab samples collected in viral transport media and assayed with a standard FDA Emergency Use Authorization (EUA) test were highly correlated with samples placed in DRUL buffer. Direct comparison of results from 162 individuals tested by FDA EUA oropharyngeal (OP) or NP swabs with co-collected saliva samples identified four otherwise unidentified positive cases in DRUL buffer. Over six months, we collected 3,724 samples from individuals ranging from 3 months to 92 years of age. This included collecting weekly samples over 10 weeks from teachers, children, and parents from a pre-school program, which allowed its safe reopening while at-risk pods were quarantined. In sum, we validated a simple, sensitive, stable, and safe PCR-based test using a self-collected saliva sample as a valuable tool for clinical diagnosis and screening at workplaces and schools.

Universal screening for SARS-CoV-2 infection among pregnant women at Elmhurst Hospital Center, Queens, New York.

BACKGROUND: Universal screening for SARS-CoV-2 infection on Labor and Delivery (L&D) units is a critical strategy to manage patient and health worker safety, especially in a vulnerable high-prevalence community. We describe the results of a SARS-CoV-2 universal screening program at the L&D Unit at Elmhurst Hospital in Queens, NY, a 545-bed public hospital serving a diverse, largely immigrant and low-income patient population and an epicenter of the global pandemic. METHODS AND FINDINGS: We conducted a retrospective cross-sectional study. All pregnant women admitted to the L&D Unit of Elmhurst Hospital from March 29, 2020 to April 22, 2020 were included for analysis. The primary outcomes of the study were: (1) SARS-CoV-2 positivity among universally screened pregnant women, stratified by demographic characteristics, maternal comorbidities, and delivery outcomes; and (2) Symptomatic or asymptomatic presentation at the time of testing among SARS-CoV-2 positive women. A total of 126 obstetric patients were screened for SARS-CoV-2 between March 29 and April 22. Of these, 37% were positive. Of the women who tested positive, 72% were asymptomatic at the time of testing. Patients who tested positive for SARS-CoV-2 were more likely to be of Hispanic ethnicity (unadjusted difference 24.4 percentage points, CI 7.9, 41.0) and report their primary language as Spanish (unadjusted difference 32.9 percentage points, CI 15.8, 49.9) than patients who tested negative. CONCLUSIONS: In this retrospective cross-sectional study of data from a universal SARS-Cov-2 screening program implemented in the L&D unit of a safety-net hospital in Queens, New York, we found over one-third of pregnant women testing positive, the majority of those asymptomatic. The rationale for universal screening at the L&D Unit at Elmhurst Hospital was to ensure safety of patients and staff during an acute surge in SARS-Cov-2 infections through appropriate identification and isolation of pregnant women with positive test results. Women were roomed by their SARS-CoV-2 status given increasing space limitations. In addition, postpartum counseling was tailored to infection status. We quickly established discharge counseling and follow-up protocols tailored to their specific social needs. The experience at Elmhurst Hospital is instructive for other L&D units serving vulnerable populations and for pandemic preparedness.