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1.
Open Forum Infect Dis ; 9(1): ofab498, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1606723

ABSTRACT

Background: The objective of this study was to characterize hospitalized coronavirus disease 2019 (COVID-19) patients and describe their real-world treatment patterns and outcomes over time. Methods: Adult patients hospitalized on May 1, 2020-December 31, 2020 with a discharge diagnosis of COVID-19 were identified from the Premier Healthcare Database. Patient and hospital characteristics, treatments, baseline severity based on oxygen support, length of stay (LOS), intensive care unit (ICU) utilization, and mortality were examined. Results: The study included 295657 patients (847 hospitals), with median age of 66 (interquartile range, 54-77) years. Among each set of demographic comparators, the majority were male, white, and over 65. Approximately 85% had no supplemental oxygen charges (NSOc) or low-flow oxygen (LFO) at baseline, whereas 75% received no more than NSOc or LFO as maximal oxygen support at any time during hospitalization. Remdesivir (RDV) and corticosteroid treatment utilization increased over time. By December, 50% were receiving RDV and 80% were receiving corticosteroids. A higher proportion initiated COVID-19 treatments within 2 days of hospitalization in December versus May (RDV, 87% vs 40%; corticosteroids, 93% vs 62%; convalescent plasma, 68% vs 26%). There was a shift toward initiating RDV in patients on NSOc or LFO (68.0% [May] vs 83.1% [December]). Median LOS decreased over time. Overall mortality was 13.5% and it was highest for severe patients (invasive mechanical ventilation/extracorporeal membrane oxygenation [IMV/ECMO], 53.7%; high-flow oxygen/noninvasive ventilation [HFO/NIV], 32.2%; LFO, 11.7%; NSOc, 7.3%). The ICU use decreased, whereas mortality decreased for NSOc and LFO. Conclusions: Clinical management of COVID-19 is rapidly evolving. This large observational study found that use of evidence-based treatments increased from May to December 2020, whereas improvement in outcomes occurred over this time-period.

2.
Ann Intern Med ; 174(7): 1037, 2021 07.
Article in English | MEDLINE | ID: covidwho-1526991

Subject(s)
COVID-19 , SARS-CoV-2 , Humans
3.
Clin Infect Dis ; 73(7): e1964-e1972, 2021 10 05.
Article in English | MEDLINE | ID: covidwho-1455261

ABSTRACT

BACKGROUND: People living with human immunodeficiency virus (HIV) may have numerous risk factors for acquiring coronavirus disease 2019 (COVID-19) and developing severe outcomes, but current data are conflicting. METHODS: Health-care providers enrolled consecutively, by nonrandom sampling, people living with HIV (PWH) with lab-confirmed COVID-19, diagnosed at their facilities between 1 April and 1 July 2020. Deidentified data were entered into an electronic Research Electronic Data Capture (REDCap) system. The primary endpoint was a severe outcome, defined as a composite endpoint of intensive care unit (ICU) admission, mechanical ventilation, or death. The secondary outcome was the need for hospitalization. RESULTS: There were 286 patients included; the mean age was 51.4 years (standard deviation, 14.4), 25.9% were female, and 75.4% were African American or Hispanic. Most patients (94.3%) were on antiretroviral therapy, 88.7% had HIV virologic suppression, and 80.8% had comorbidities. Within 30 days of testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 164 (57.3%) patients were hospitalized, and 47 (16.5%) required ICU admission. Mortality rates were 9.4% (27/286) overall, 16.5% (27/164) among those hospitalized, and 51.5% (24/47) among those admitted to an ICU. The primary composite endpoint occurred in 17.5% (50/286) of all patients and 30.5% (50/164) of hospitalized patients. Older age, chronic lung disease, and hypertension were associated with severe outcomes. A lower CD4 count (<200 cells/mm3) was associated with the primary and secondary endpoints. There were no associations between the ART regimen or lack of viral suppression and the predefined outcomes. CONCLUSIONS: Severe clinical outcomes occurred commonly in PWH with COVID-19. The risks for poor outcomes were higher in those with comorbidities and lower CD4 cell counts, despite HIV viral suppression. CLINICAL TRIALS REGISTRATION: NCT04333953.


Subject(s)
COVID-19 , HIV Infections , Aged , Female , HIV , HIV Infections/drug therapy , HIV Infections/epidemiology , Hospitalization , Humans , Middle Aged , Registries , SARS-CoV-2
4.
Clin Infect Dis ; 2021 Oct 01.
Article in English | MEDLINE | ID: covidwho-1447582

ABSTRACT

BACKGROUND: Remdesivir (RDV) improved clinical outcomes among hospitalized COVID-19 patients in randomized trials, but data from clinical practice are limited. METHODS: We examined survival outcomes for US patients hospitalized with COVID-19 between Aug-Nov 2020 and treated with RDV within two-days of hospitalization vs. those not receiving RDV during their hospitalization using the Premier Healthcare Database. Preferential within-hospital propensity score matching with replacement was used. Additionally, patients were also matched on baseline oxygenation level (no supplemental oxygen charges (NSO), low-flow oxygen (LFO), high-flow oxygen/non-invasive ventilation (HFO/NIV) and invasive mechanical ventilation/ECMO (IMV/ECMO) and two-month admission window and excluded if discharged within 3-days of admission (to exclude anticipated discharges/transfers within 72-hrs consistent with ACTT-1 study). Cox Proportional Hazards models were used to assess time to 14-/28-day mortality overall and for patients on NSO, LFO, HFO/NIV and IMV/ECMO. RESULTS: 28,855 RDV patients were matched to 16,687 unique non-RDV patients. Overall, 10.6% and 15.4% RDV patients died within 14- and 28-days, respectively compared with 15.4% and 19.1% non-RDV patients. Overall, RDV was associated with a reduction in mortality at 14-days (HR[95% CI]: 0.76[0.70-0.83]) and 28-days (0.89[0.82-0.96]). This mortality benefit was also seen for NSO, LFO and IMV/ECMO at 14-days (NSO:0.69[0.57-0.83], LFO:0.68[0.80-0.77], IMV/ECMO:0.70[0.58-0.84]) and 28-days (NSO:0.80[0.68-0.94], LFO:0.77[0.68-0.86], IMV/ECMO:0.81[0.69-0.94]). Additionally, HFO/NIV RDV group had a lower risk of mortality at 14-days (0.81[0.70-0.93]) but no statistical significance at 28-days. CONCLUSIONS: RDV initiated upon hospital admission was associated with improved survival among COVID-19 patients. Our findings complement ACTT-1 and support RDV as a foundational treatment for hospitalized COVID-19 patients.

5.
medRxiv ; 2021 Feb 08.
Article in English | MEDLINE | ID: covidwho-1388083

ABSTRACT

BACKGROUND: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. OBJECTIVE: To define performance standards and predict the clinical, epidemiological, and economic outcomes of nationwide, home-based, antigen testing. DESIGN: A simple compartmental epidemic model estimated viral transmission, clinical history, and resource use, with and without testing. DATA SOURCES: Parameter values and ranges informed by Centers for Disease Control guidance and published literature. TARGET POPULATION: United States population. TIME HORIZON: 60 days. PERSPECTIVE: Societal. Costs include: testing, inpatient care, and lost workdays. INTERVENTION: Home-based SARS-CoV-2 antigen testing. OUTCOME MEASURES: Cumulative infections and deaths, numbers isolated and/or hospitalized, and total costs. RESULTS OF BASE-CASE ANALYSIS: Without a testing intervention, the model anticipates 15 million infections, 125,000 deaths, and $10.4 billion in costs ($6.5 billion inpatient; $3.9 billion lost productivity) over a 60-day horizon. Weekly availability of testing may avert 4 million infections and 19,000 deaths, raising costs by $21.5 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.0 billion) and workdays lost ($13.9 billion), yielding incremental costs per infection (death) averted of $5,400 ($1,100,000). RESULTS OF SENSITIVITY ANALYSIS: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios: large reductions in infections, mortality, and hospitalizations; and costs per death averted roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5-17 million). LIMITATIONS: Analysis restricted to at-home testing and limited by uncertainties about test performance. CONCLUSION: High-frequency home testing for SARS-CoV-2 using an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy.

6.
Clin Microbiol Infect ; 27(7): 1007-1010, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1141681

ABSTRACT

OBJECTIVES: To compare the gender distribution of clinical trial leadership in coronavirus disease 2019 (COVID-19) clinical trials. METHODS: We searched https://clinicaltrials.gov/ and retrieved all clinical trials on COVID-19 from 1 January 2020 to 26 June 2020. As a comparator group, we have chosen two fields that are not related to emerging infections and infectious diseases: and considered not directly affected by the pandemic: breast cancer and type 2 diabetes mellitus (T2DM) and included studies within the aforementioned study period as well as those registered in the preceding year (pre-study period: 1 January 2019 to 31 December 2019). Gender of the investigator was predicted using the genderize.io application programming interface. The repository of the data sets used to collect and analyse the data are available at https://osf.io/k2r57/. RESULTS: Only 27.8% (430/1548) of principal investigators among COVID-19-related studies were women, which is significantly different compared with 54.9% (156/284) and 42.1% (56/133) for breast cancer (p < 0.005) and T2DM (p < 0.005) trials over the same period, respectively. During the pre-study period, the proportion of principal investigators who were predicted to be women were 49.7% (245/493) and 44.4% (148/333) for breast cancer and T2DM trials, respectively, and the difference was not statistically significant when compared with results from the study period (p > 0.05). CONCLUSION: We demonstrate that less than one-third of COVID-19-related clinical trials are led by women, half the proportion observed in non-COVID-19 trials over the same period, which remained similar to the pre-study period. These gender disparities during the pandemic may not only indicate a lack of female leadership in international clinical trials and involvement in new projects but also reveal imbalances in women's access to research activities and funding during health emergencies.


Subject(s)
COVID-19 , Leadership , Women , Breast Neoplasms , Clinical Trials as Topic/statistics & numerical data , Diabetes Mellitus, Type 2 , Female , Humans , Male , Research Personnel/statistics & numerical data , Sex Ratio , Sexism
7.
Ann Intern Med ; 174(6): 803-810, 2021 06.
Article in English | MEDLINE | ID: covidwho-1120310

ABSTRACT

BACKGROUND: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. OBJECTIVE: To define performance standards and predict the clinical, epidemiologic, and economic outcomes of nationwide, home-based antigen testing. DESIGN: A simple compartmental epidemic model that estimated viral transmission, portrayed disease progression, and forecast resource use, with and without testing. DATA SOURCES: Parameter values and ranges as informed by Centers for Disease Control and Prevention guidance and published literature. TARGET POPULATION: U.S. population. TIME HORIZON: 60 days. PERSPECTIVE: Societal; costs included testing, inpatient care, and lost workdays. INTERVENTION: Home-based SARS-CoV-2 antigen testing. OUTCOME MEASURES: Cumulative infections and deaths, number of persons isolated and hospitalized, and total costs. RESULTS OF BASE-CASE ANALYSIS: Without a testing intervention, the model anticipates 11.6 million infections, 119 000 deaths, and $10.1 billion in costs ($6.5 billion in inpatient care and $3.5 billion in lost productivity) over a 60-day horizon. Weekly availability of testing would avert 2.8 million infections and 15 700 deaths, increasing costs by $22.3 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.5 billion) and workdays lost ($14.0 billion), yielding incremental cost-effectiveness ratios of $7890 per infection averted and $1 430 000 per death averted. RESULTS OF SENSITIVITY ANALYSIS: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios, with large reductions in infections, mortality, and hospitalizations. Costs per death averted are roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5 to $17 million). LIMITATIONS: Analysis was restricted to at-home testing. There are uncertainties concerning test performance. CONCLUSION: High-frequency home testing for SARS-CoV-2 with an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy. PRIMARY FUNDING SOURCE: National Institutes of Health.


Subject(s)
COVID-19 Testing/economics , COVID-19/diagnosis , COVID-19/prevention & control , Home Care Services/economics , Mass Screening/economics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/prevention & control , COVID-19/mortality , Cost-Benefit Analysis , Disease Progression , Female , Humans , Male , Pandemics , Pneumonia, Viral/mortality , Pneumonia, Viral/virology , SARS-CoV-2 , Sick Leave/economics , United States/epidemiology
8.
Ann Intern Med ; 174(1): 69-79, 2021 01.
Article in English | MEDLINE | ID: covidwho-1067970

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiologic agent of coronavirus disease 2019 (COVID-19), has spread globally in a few short months. Substantial evidence now supports preliminary conclusions about transmission that can inform rational, evidence-based policies and reduce misinformation on this critical topic. This article presents a comprehensive review of the evidence on transmission of this virus. Although several experimental studies have cultured live virus from aerosols and surfaces hours after inoculation, the real-world studies that detect viral RNA in the environment report very low levels, and few have isolated viable virus. Strong evidence from case and cluster reports indicates that respiratory transmission is dominant, with proximity and ventilation being key determinants of transmission risk. In the few cases where direct contact or fomite transmission is presumed, respiratory transmission has not been completely excluded. Infectiousness peaks around a day before symptom onset and declines within a week of symptom onset, and no late linked transmissions (after a patient has had symptoms for about a week) have been documented. The virus has heterogeneous transmission dynamics: Most persons do not transmit virus, whereas some cause many secondary cases in transmission clusters called "superspreading events." Evidence-based policies and practices should incorporate the accumulating knowledge about transmission of SARS-CoV-2 to help educate the public and slow the spread of this virus.


Subject(s)
COVID-19/transmission , SARS-CoV-2/isolation & purification , Aerosols , Equipment Contamination , Fomites/virology , Humans , RNA, Viral/analysis , Risk Factors
9.
JAMA ; 324(16): 1651-1669, 2020 10 27.
Article in English | MEDLINE | ID: covidwho-865967

ABSTRACT

Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices. Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV. Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations. Findings: From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic. Conclusion and Relevance: Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.


Subject(s)
Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , AIDS-Related Opportunistic Infections/drug therapy , Age Factors , Anti-Retroviral Agents/economics , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus Infections/epidemiology , Drug Administration Schedule , Drug Costs , Drug Resistance, Viral/genetics , Drug Substitution/standards , Drug Therapy, Combination/methods , Female , HIV Infections/blood , HIV Infections/diagnosis , Humans , International Agencies , Male , Pandemics , Pneumonia, Viral/epidemiology , Polypharmacy , Pre-Exposure Prophylaxis/methods , Pregnancy , Pregnancy Complications, Infectious/drug therapy , RNA, Viral/blood , SARS-CoV-2 , Societies, Medical , United States , Viral Load/genetics
10.
Journal of Infectious Diseases ; 222(Supplement_1):S63-S69, 2020.
Article in English | MEDLINE | ID: covidwho-662281

ABSTRACT

BACKGROUND: People with human immunodeficiency virus (PWH) face increased risks for heart failure and adverse heart failure outcomes. Myocardial steatosis predisposes to diastolic dysfunction, a heart failure precursor. We aimed to characterize myocardial steatosis and associated potential risk factors among a subset of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) participants. METHODS: Eighty-two PWH without known heart failure successfully underwent cardiovascular magnetic resonance spectroscopy, yielding data on intramyocardial triglyceride (IMTG) content (a continuous marker for myocardial steatosis extent). Logistic regression models were applied to investigate associations between select clinical characteristics and odds of increased or markedly increased IMTG content. RESULTS: Median (Q1, Q3) IMTG content was 0.59% (0.28%, 1.15%). IMTG content was increased (>0.5%) among 52% and markedly increased (>1.5%) among 22% of participants. Parameters associated with increased IMTG content included age (P = .013), body mass index (BMI) ≥25 kg/m2 (P = .055), history of intravenous drug use (IVDU) (P = .033), and nadir CD4 count <350 cells/mm³ (P = .055). Age and BMI ≥25 kg/m2 were additionally associated with increased odds of markedly increased IMTG content (P = .049 and P = .046, respectively). CONCLUSIONS: A substantial proportion of antiretroviral therapy-treated PWH exhibited myocardial steatosis. Age, BMI ≥25 kg/m2, low nadir CD4 count, and history of IVDU emerged as possible risk factors for myocardial steatosis in this group. CLINICAL TRIALS REGISTRATION: NCT02344290;NCT03238755.

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