ABSTRACT
Importance Coronavirus disease 2019 (COVID-19) outbreaks are frequent occurrences in nursing homes and long-term care facilities (LTCFs), resulting in subsequent hospitalization and death. Rationale Virus-neutralizing monoclonal antibodies demonstrate a significant decrease in both viral load and hospital transfer rate among patients with mild-to-moderate COVID-19 infection. Objective To assess the clinical outcomes of COVID-19 patients with mild-to-moderate symptoms in LTCFs who received LY-CoV555 as compared to those who did not receive this treatment. Design Retrospective case-control study and logistic regression analysis. Setting LTCFs in New York. Participants Two-hundred forty-six (246) LTCF patients diagnosed with mild-to-moderate COVID-19 infection with positive COVID-19 polymerase chain reaction (PCR) from November 15, 2020, to January 31, 2021. Methods Two-hundred forty-six (246) COVID-19 patients were identified from electronic medical records, out of which 160 cases were exposed to LY-CoV555 treatment (700 mg single dose, intravenous infusion). Eighty-six (86) patients were unexposed controls who did not receive monoclonal antibodies, LY-CoV555. Outcome We assessed the odds of death and hospitalization of exposed cases as compared to unexposed controls. Using logistic regression analysis, we also assessed the risk factors associated with these outcomes in the entire sample population. Results The mean age of the entire sample was 82.4 years. Fifty-two percent (52%) of patients (n = 129) were female and 48% (n = 117) were male. The mean ages of the exposed group and the unexposed group were 81 years and 84 years, respectively. At the end of the study, 92% (148/160) of the exposed group were alive or not transferred to the hospital as compared to 79% (68/86) patients of the unexposed group (OR 3.23, 95% CI: (1.48, 7.31), p-value = 0.0032). Three percent (3%; 5/160) of patients died in the exposed group compared to 10% (9/86) of patients who died in the unexposed group (OR = 0.25, 95% CI: (0.1, 0.85), p-value = 0.0257). Four point thirty-seven percent (4.37%; 7/160) of patients in the exposed group and 10.46% (9/86) of patients in the unexposed group were transferred to the hospital (OR = 0.35, 95% CI: (0.15, 1.08), p-value = 0.0793). Conclusion Early treatment with monoclonal antibody LY-CoV555 is associated with decreased mortality among high-risk patients with mild-to-moderate COVID-19 infection in LTCFs. Although not statistically significant, there was a trend towards a lower risk of hospitalization in patients treated with LY-CoV555.
ABSTRACT
Rationale Due to the cluster and associated comorbidities in residents of long-term care facilities (LTCFs), COVID-19-associated morbidity and mortality are significantly increased. Multiple therapeutic options, including hydroxychloroquine (HCQ) and azithromycin (AZI), were tried initially to treat moderate to severe COVID-19 and high-risk patients in LTCFs, but they were abandoned due to unfavorable reports. As a less toxic option, we initiated treatment with doxycycline (DOXY) very early in the course of illness. DOXY has antiviral, cardioprotective, immunomodulatory, and anti-inflammatory properties, but the efficacy of early intervention with DOXY in high-risk COVID-19 patients in LTCFs is unknown. Objective The goal of this retrospective study is to describe the clinical outcomes of high-risk COVID-19 patients with moderate to severe symptoms in LTCFs after early intervention with DOXY. Design Case-series analysis Setting LTCFs in New York Participants This observational study examines 89 patients who were diagnosed with COVID-19 from March 18 to May 13, 2020. Exposure All patients who were diagnosed with COVID-19 received DOXY and regular standard of care within 12 hours of the onset of symptoms. Additionally, four patients received meropenem, three patients received Zosyn, two patients received linezolid, and two patients received Bactrim DS. Four patients were on chronic ventilator support. No patients received any steroids or any other antiviral or immunomodulatory agents. The majority of the patients received zinc and calcium supplements as well. Main outcomes and measures Assessed measures were patients' characteristics, fever, shortness of breath (SOB), cough, oxygen saturation/pulse oximetry (POX), radiologic improvements, laboratory tests, DOXY side effects, hospital transfers, and death. Results Eighty-nine (89) high-risk patients, who developed a sudden onset of fever, cough, SOB, and hypoxia and were diagnosed with COVID-19, were treated with DOXY (100 mg PO or intravenous (IV) for seven days) and regular standard of care. Eighty-five percent (85%) of patients (n=76) demonstrated clinical recovery that is defined as resolution of fever (average 3.7 days, Coeff = -0.96, p = 0.0001), resolution of SOB (average 4.2 days), and improvement of POX: average 84% before treatment and average 95% after treatment (84.7 ± 7% vs. 95 ± 2.6%, p = 0.0001). Higher pre- and post-treatment POX is associated with lower mortality (oxygen saturation (Spo2) vs. Death, Coeff = -0.01, p = 0.023; post-Spo2 vs. Death, Coeff = -0.05, p = 0.0002). Within 10 days of symptom onset, 3% of patients (n=3) were transferred to hospital due to clinical deterioration and 11% of patients (n=10) died. The result was followed for 30 days from the onset of symptoms in each patient. Conclusion Early treatment with DOXY for high-risk patients with moderate to severe COVID-19 infections in non-hospital settings, such as LTCFs, is associated with early clinical recovery, decreased hospitalization, and decreased mortality.