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2.
Clin Infect Dis ; 2021 Dec 15.
Article in English | MEDLINE | ID: covidwho-1746925

ABSTRACT

BACKGROUND: There is an urgent need to understand the real-world effectiveness of remdesivir in the treatment of SARS-CoV-2. METHODS: This was a retrospective comparative effectiveness study. Individuals hospitalized in a large private healthcare network in the US from February 23, 2020 through February 11, 2021 with a positive test for SARS-CoV-2 and ICD-10 diagnosis codes consistent with symptomatic COVID-19 were included. Remdesivir recipients were matched to controls using time-dependent propensity scores. The primary outcome was time to improvement with a secondary outcome of time to death. RESULTS: Of 96,859 COVID-19 patients, 42,473 (43.9%) received at least one remdesivir dose. The median age of remdesivir recipients was 65 years, 23,701 (55.8%) were male and 22,819 (53.7%) were non-white. Matches were found for 18,328 patients (43.2%). Remdesivir recipients were significantly more likely to achieve clinical improvement by 28 days (adjusted hazard ratio [1.19, 95% confidence interval (CI), 1.16-1.22]). Remdesivir patients on no oxygen (aHR 1.30, 95% CI 1.22-1.38) or low-flow oxygen (aHR 1.23, 95% CI 1.19-1.27) were significantly more likely to achieve clinical improvement by 28 days. There was no significant impact on the likelihood of mortality overall (aHR 1.02, 95% CI 0.97-1.08). Remdesivir recipients on low-flow oxygen were significantly less likely to die than controls (aHR 0.85, 95% CI 0.77-0.92; 28-day mortality 8.4% [865 deaths] for remdesivir patients, 12.5% [1,334 deaths] for controls). CONCLUSIONS: These results support the use of remdesivir for hospitalized COVID-19 patients on no or low-flow oxygen. Routine initiation of remdesivir in more severely ill patients is unlikely to be beneficial.

4.
JAMA health forum ; 2(7), 2021.
Article in English | EuropePMC | ID: covidwho-1678738

ABSTRACT

Key Points Question Has the COVID-19 pandemic been associated with any changes in the clinical content of ambulatory care in the US? Findings In this cross-sectional study of serial data from the IQVIA National Disease and Therapeutic Index, there was a moderate rebound in office-based care during the second half of 2020, while telemedicine accounted for 23.9% of care observed. Office-based care during the pandemic (quarters 2-4 of 2020) involved 58.0% long-term, 23.0% short-term, and 25.6% preventive diagnoses, while telemedicine care involved substantially greater long-term (77.2%), modestly greater short-term (26.8%), and almost no preventive (2.7%) diagnoses. Meaning In contrast to office-based care, telemedicine was more commonly used for established patients and substantially greater delivery of psychiatric or behavioral treatments than preventive care. Importance While the COVID-19 pandemic has been associated with some substitution of telemedicine for office-based care in the US, to our knowledge, little is known regarding the pandemic’s association with the clinical content of ambulatory care. Objective To characterize changes in the clinical content of ambulatory care among office-based vs telemedicine encounters in the US before vs during the COVID-19 pandemic. Design, Settings, and Participants This analysis of serial cross-sectional data from the IQVIA National Disease and Therapeutic Index was a 2-stage, stratified nationally representative audit of outpatient care in the US from January 1, 2018, through December 31, 2020. The National Disease and Therapeutic Index generates approximately 33 617 quarterly visits that are projected to 306.7 million national visits based on the survey design. Main Outcomes and Measures (1) Prevalence of common diagnoses and (2) mix of long-term, short-term, and preventive care. Results The mean (SD) number of projected quarterly, in-person, office-based visits was 282.1 (1.4) million in 2018 and 284.7 (10.3) in 2019 before declining to 250.8 million in quarter 1 of 2020 and 147.8 million in quarter 2 of 2020 and then increasing moderately to 181.5 million in quarter 3 of 2020 and 180.2 million in quarter 4 of 2020. The mean (SD) number of telemedicine visits was 2.8 (0.4) million in 2018 and 3.0 (0.1) million in 2019 before increasing to 8.6 million in quarter 1 of 2020 and 72.2 million in quarter 2 of 2020 and then declining notably to 43.8 million in quarter 3 of 2020 and 44.2 million in quarter 4 of 2020. Office-based care during the second through fourth quarters of 2020 involved 58.0% long-term, 23.0% short-term, and 25.6% preventive care. In contrast to office-based care, 4 of the top 10 diagnoses that were treated by telemedicine during 2020 were for psychiatric or behavioral conditions: depression, attention deficit/hyperactivity, anxiety, and bipolar disorders. Throughout this period, approximately half of office-based visits and nearly two-thirds of telemedicine visits were for established rather than new patients. Conclusions and Relevance This cross-sectional study’s findings suggest that while telemedicine rapidly increased early during course of the COVID-19 pandemic, its use declined modestly since then. In contrast to office-based care, telemedicine was more commonly used for established patients and substantially greater delivery of psychiatric or behavioral treatments rather than preventive care. This cross-sectional study of data from the IQVIA National Disease and Therapeutic Index examines changes in the clinical content of ambulatory care among office-based vs telemedicine encounters in the US during the COVID-19 pandemic.

5.
Lancet Rheumatol ; 4(1): e33-e41, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1591231

ABSTRACT

BACKGROUND: Many individuals take long-term immunosuppressive medications. We evaluated whether these individuals have worse outcomes when hospitalised with COVID-19 compared with non-immunosuppressed individuals. METHODS: We conducted a retrospective cohort study using data from the National COVID Cohort Collaborative (N3C), the largest longitudinal electronic health record repository of patients in hospital with confirmed or suspected COVID-19 in the USA, between Jan 1, 2020, and June 11, 2021, within 42 health systems. We compared adults with immunosuppressive medications used before admission to adults without long-term immunosuppression. We considered immunosuppression overall, as well as by 15 classes of medication and three broad indications for immunosuppressive medicines. We used Fine and Gray's proportional subdistribution hazards models to estimate the hazard ratio (HR) for the risk of invasive mechanical ventilation, with the competing risk of death. We used Cox proportional hazards models to estimate HRs for in-hospital death. Models were adjusted using doubly robust propensity score methodology. FINDINGS: Among 231 830 potentially eligible adults in the N3C repository who were admitted to hospital with confirmed or suspected COVID-19 during the study period, 222 575 met the inclusion criteria (mean age 59 years [SD 19]; 111 269 [50%] male). The most common comorbidities were diabetes (23%), pulmonary disease (17%), and renal disease (13%). 16 494 (7%) patients had long-term immunosuppression with medications for diverse conditions, including rheumatological disease (33%), solid organ transplant (26%), or cancer (22%). In the propensity score matched cohort (including 12 841 immunosuppressed patients and 29 386 non-immunosuppressed patients), immunosuppression was associated with a reduced risk of invasive ventilation (HR 0·89, 95% CI 0·83-0·96) and there was no overall association between long-term immunosuppression and the risk of in-hospital death. None of the 15 medication classes examined were associated with an increased risk of invasive mechanical ventilation. Although there was no statistically significant association between most drugs and in-hospital death, increases were found with rituximab for rheumatological disease (1·72, 1·10-2·69) and for cancer (2·57, 1·86-3·56). Results were generally consistent across subgroup analyses that considered race and ethnicity or sex, as well as across sensitivity analyses that varied exposure, covariate, and outcome definitions. INTERPRETATION: Among this cohort, with the exception of rituximab, there was no increased risk of mechanical ventilation or in-hospital death for the rheumatological, antineoplastic, or antimetabolite therapies examined. FUNDING: None.

6.
Ann Intern Med ; 174(10): 1395-1403, 2021 10.
Article in English | MEDLINE | ID: covidwho-1481181

ABSTRACT

BACKGROUND: Relatively little is known about the use patterns of potential pharmacologic treatments of COVID-19 in the United States. OBJECTIVE: To use the National COVID Cohort Collaborative (N3C), a large, multicenter, longitudinal cohort, to characterize the use of hydroxychloroquine, remdesivir, and dexamethasone, overall as well as across individuals, health systems, and time. DESIGN: Retrospective cohort study. SETTING: 43 health systems in the United States. PARTICIPANTS: 137 870 adults hospitalized with COVID-19 between 1 February 2020 and 28 February 2021. MEASUREMENTS: Inpatient use of hydroxychloroquine, remdesivir, or dexamethasone. RESULTS: Among 137 870 persons hospitalized with confirmed or suspected COVID-19, 8754 (6.3%) received hydroxychloroquine, 29 272 (21.2%) remdesivir, and 53 909 (39.1%) dexamethasone during the study period. Since the release of results from the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial in mid-June, approximately 78% to 84% of people who have had invasive mechanical ventilation have received dexamethasone or other glucocorticoids. The use of hydroxychloroquine increased during March 2020, peaking at 42%, and started declining by April 2020. By contrast, remdesivir and dexamethasone use gradually increased over the study period. Dexamethasone and remdesivir use varied substantially across health centers (intraclass correlation coefficient, 14.2% for dexamethasone and 84.6% for remdesivir). LIMITATION: Because most N3C data contributors are academic medical centers, findings may not reflect the experience of community hospitals. CONCLUSION: Dexamethasone, an evidence-based treatment of COVID-19, may be underused among persons who are mechanically ventilated. The use of remdesivir and dexamethasone varied across health systems, suggesting variation in patient case mix, drug access, treatment protocols, and quality of care. PRIMARY FUNDING SOURCE: National Center for Advancing Translational Sciences; National Heart, Lung, and Blood Institute; and National Institute on Aging.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Dexamethasone/therapeutic use , Hydroxychloroquine/therapeutic use , Practice Patterns, Physicians' , Adenosine Monophosphate/therapeutic use , Adolescent , Adult , Aged , Alanine/therapeutic use , Anti-Inflammatory Agents/therapeutic use , COVID-19/therapy , Female , Humans , Male , Middle Aged , Pandemics , Respiration, Artificial , Retrospective Studies , SARS-CoV-2 , United States , Young Adult
7.
Diabetes Care ; 44(7): 1564-1572, 2021 07.
Article in English | MEDLINE | ID: covidwho-1405389

ABSTRACT

OBJECTIVE: To determine the respective associations of premorbid glucagon-like peptide-1 receptor agonist (GLP1-RA) and sodium-glucose cotransporter 2 inhibitor (SGLT2i) use, compared with premorbid dipeptidyl peptidase 4 inhibitor (DPP4i) use, with severity of outcomes in the setting of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. RESEARCH DESIGN AND METHODS: We analyzed observational data from SARS-CoV-2-positive adults in the National COVID Cohort Collaborative (N3C), a multicenter, longitudinal U.S. cohort (January 2018-February 2021), with a prescription for GLP1-RA, SGLT2i, or DPP4i within 24 months of positive SARS-CoV-2 PCR test. The primary outcome was 60-day mortality, measured from positive SARS-CoV-2 test date. Secondary outcomes were total mortality during the observation period and emergency room visits, hospitalization, and mechanical ventilation within 14 days. Associations were quantified with odds ratios (ORs) estimated with targeted maximum likelihood estimation using a super learner approach, accounting for baseline characteristics. RESULTS: The study included 12,446 individuals (53.4% female, 62.5% White, mean ± SD age 58.6 ± 13.1 years). The 60-day mortality was 3.11% (387 of 12,446), with 2.06% (138 of 6,692) for GLP1-RA use, 2.32% (85 of 3,665) for SGLT2i use, and 5.67% (199 of 3,511) for DPP4i use. Both GLP1-RA and SGLT2i use were associated with lower 60-day mortality compared with DPP4i use (OR 0.54 [95% CI 0.37-0.80] and 0.66 [0.50-0.86], respectively). Use of both medications was also associated with decreased total mortality, emergency room visits, and hospitalizations. CONCLUSIONS: Among SARS-CoV-2-positive adults, premorbid GLP1-RA and SGLT2i use, compared with DPP4i use, was associated with lower odds of mortality and other adverse outcomes, although DPP4i users were older and generally sicker.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , Glucagon-Like Peptide-1 Receptor/agonists , Sodium-Glucose Transporter 2 Inhibitors , Adult , Aged , COVID-19/diagnosis , Diabetes Mellitus, Type 2/drug therapy , Female , Humans , Longitudinal Studies , Male , Middle Aged , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , United States
8.
J Med Econ ; 24(1): 1060-1069, 2021.
Article in English | MEDLINE | ID: covidwho-1345680

ABSTRACT

AIMS: The Novel Coronavirus (COVID-19) has infected over two hundred million worldwide and caused 4.4 million of deaths as of August 2021. Vaccines were quickly developed to address the pandemic. We sought to analyze the cost-effectiveness and budget impact of a non-specified vaccine for COVID-19. MATERIALS AND METHODS: We constructed a Markov model of COVID-19 infections using a susceptible-exposed-infected-recovered structure over a 1-year time horizon from a U.S. healthcare sector perspective. The model consisted of two arms: do nothing and COVID-19 vaccine. Hospitalization and mortality rates were calibrated to U.S. COVID-19 reports as of November 2020. We performed economic calculations of costs in 2020 U.S. dollars and effectiveness in units of quality-adjusted life years (QALYs) to measure the budget impact and incremental cost-effectiveness at a $100,000/QALY threshold. RESULTS: Vaccines have a high probability of reducing healthcare costs and increasing QALYs compared to doing nothing. Simulations showed reductions in hospital days and mortality by more than 50%. Even though this represents a major U.S. investment, the budget impacts of these technologies could save program costs by up to 60% or more if uptake is high. LIMITATIONS: The economic evaluation draws on the reported values of the clinical benefits of COVID-19 vaccines, although we do not currently have long-term conclusive data about COVID-19 vaccine efficacies. CONCLUSIONS: Spending on vaccines to mitigate COVID-19 infections offer high-value potential that society should consider. Unusually high uptake in vaccines in a short amount of time could result in unprecedented budget impacts to government and commercial payers. Governments should focus on expanding health system infrastructure and subsidizing payer coverage to deliver these vaccines efficiently.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Cost-Benefit Analysis , Humans , Pandemics , Quality-Adjusted Life Years , SARS-CoV-2
9.
J Am Pharm Assoc (2003) ; 61(6): e32-e41, 2021.
Article in English | MEDLINE | ID: covidwho-1313200

ABSTRACT

BACKGROUND: Despite the importance of pharmacies in ensuring medications and health care needs are met, there is limited up-to-date information regarding access to pharmacies or their services in the United States. OBJECTIVES: To evaluate trends and disparities in access to pharmacies in 4 largest cities in the United States, New York City, Los Angeles, Houston, and Chicago, by neighborhood racial and ethnic composition from 2015 to 2020. METHODS: Data from the National Council for Prescription Drug Programs (2015-2020) and the American Community Survey (2015-2019) were used. We examined neighborhoods (i.e., census tracts) and evaluated disparities in "pharmacy deserts" (low-income neighborhoods (1) whose average distance to the nearest pharmacy was at least 1 mile or (2) whose average distance to the nearest pharmacy was at least 0.5 mile and at least 100 households had no vehicle access). We also evaluated the differences in pharmacy closures and the availability of pharmacy services. RESULTS: From 2015 to 2020, the percent of neighborhoods with pharmacy deserts declined in New York City (from 1.6% to 0.9% of neighborhoods, P < 0.01), remained stable in Los Angeles (13.7% to 13.4%, P = 0.58) and Houston (27.0% to 28.5%, P = 0.18), and increased in Chicago (15.0% to 19.9%, P < 0.01). Pharmacy deserts were persistently more common in Black and Latino neighborhoods in all 4 cities. As of 2020, pharmacies in Black and Latino neighborhoods were also more likely to close and less likely to offer immunization, 24-hour, and drive-through services than pharmacies in other neighborhoods. CONCLUSION: To reduce disparities in access to medications and health care services, including those in response to the coronavirus disease 2019 pandemic (e.g., testing and vaccinations), policies that improve pharmacy access and expand the provision of pharmacy services in minority neighborhoods are critical.


Subject(s)
COVID-19 , Pharmaceutical Services , Pharmacies , Chicago , Health Services Accessibility , Humans , Los Angeles , New York City , SARS-CoV-2 , United States
10.
Health Aff (Millwood) ; 40(5): 802-811, 2021 05.
Article in English | MEDLINE | ID: covidwho-1211720

ABSTRACT

The accessibility of pharmacies may be an overlooked contributor to persistent racial and ethnic disparities in the use of prescription medications and essential health care services within urban areas in the US. We examined the availability and geographic accessibility of pharmacies across neighborhoods based on their racial/ethnic composition in the thirty most populous US cities. In all cities examined, we found persistently fewer pharmacies located in Black and Hispanic/Latino neighborhoods than White or diverse neighborhoods throughout 2007-15. In 2015 there were disproportionately more pharmacy deserts in Black or Hispanic/Latino neighborhoods than in White or diverse neighborhoods, including those that are not federally designated Medically Underserved Areas. These disparities were most pronounced in Chicago, Illinois; Los Angeles, California; Baltimore, Maryland; Philadelphia, Pennsylvania; Milwaukee, Wisconsin; Dallas, Texas; Boston, Massachusetts; and Albuquerque, New Mexico. We also found that Black and Hispanic/Latino neighborhoods were more likely to experience pharmacy closures compared with other neighborhoods. Our findings suggest that efforts to increase access to medications and essential health care services, including in response to COVID-19, should consider policies that ensure equitable pharmacy accessibility across neighborhoods in US cities. Such efforts could include policies that encourage pharmacies to locate in pharmacy deserts, including increases to Medicaid and Medicare reimbursement rates for pharmacies most at risk for closure.


Subject(s)
COVID-19 , Pharmacies , African Americans , Aged , Baltimore , Boston , Chicago , Health Services Accessibility , Humans , Illinois , Los Angeles , Massachusetts , Medicare , New Mexico , Philadelphia , SARS-CoV-2 , Texas , United States , Wisconsin
11.
PLoS One ; 16(4): e0248080, 2021.
Article in English | MEDLINE | ID: covidwho-1199975

ABSTRACT

BACKGROUND: Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs) may positively or negatively impact outcomes in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We investigated the association of ARB or ACEI use with coronavirus disease 2019 (COVID-19)-related outcomes in US Veterans with treated hypertension using an active comparator design, appropriate covariate adjustment, and negative control analyses. METHODS AND FINDINGS: In this retrospective cohort study of Veterans with treated hypertension in the Veterans Health Administration (01/19/2020-08/28/2020), we compared users of (A) ARB/ACEI vs. non-ARB/ACEI (excluding Veterans with compelling indications to reduce confounding by indication) and (B) ARB vs. ACEI among (1) SARS-CoV-2+ outpatients and (2) COVID-19 hospitalized inpatients. The primary outcome was all-cause hospitalization or mortality (outpatients) and all-cause mortality (inpatients). We estimated hazard ratios (HR) using propensity score-weighted Cox regression. Baseline characteristics were well-balanced between exposure groups after weighting. Among outpatients, there were 5.0 and 6.0 primary outcomes per 100 person-months for ARB/ACEI (n = 2,482) vs. non-ARB/ACEI (n = 2,487) users (HR 0.85, 95% confidence interval [CI] 0.73-0.99, median follow-up 87 days). Among outpatients who were ARB (n = 4,877) vs. ACEI (n = 8,704) users, there were 13.2 and 14.8 primary outcomes per 100 person-months (HR 0.91, 95%CI 0.86-0.97, median follow-up 85 days). Among inpatients who were ARB/ACEI (n = 210) vs. non-ARB/ACEI (n = 275) users, there were 3.4 and 2.0 all-cause deaths per 100 person months (HR 1.25, 95%CI 0.30-5.13, median follow-up 30 days). Among inpatients, ARB (n = 1,164) and ACEI (n = 2,014) users had 21.0 vs. 17.7 all-cause deaths, per 100 person-months (HR 1.13, 95%CI 0.93-1.38, median follow-up 30 days). CONCLUSIONS: This observational analysis supports continued ARB or ACEI use for patients already using these medications before SARS-CoV-2 infection. The novel beneficial association observed among outpatients between users of ARBs vs. ACEIs on hospitalization or mortality should be confirmed with randomized trials.


Subject(s)
Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , COVID-19/pathology , Hypertension/drug therapy , Aged , COVID-19/mortality , COVID-19/virology , Female , Hospitalization/statistics & numerical data , Humans , Hypertension/pathology , Male , Middle Aged , Propensity Score , Proportional Hazards Models , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Survival Rate , Veterans
12.
JAMA Netw Open ; 4(3): e213071, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-1147545

ABSTRACT

Importance: Clinical effectiveness data on remdesivir are urgently needed, especially among diverse populations and in combination with other therapies. Objective: To examine whether remdesivir administered with or without corticosteroids for treatment of coronavirus disease 2019 (COVID-19) is associated with more rapid clinical improvement in a racially/ethnically diverse population. Design, Setting, and Participants: This retrospective comparative effectiveness research study was conducted from March 4 to August 29, 2020, in a 5-hospital health system in the Baltimore, Maryland, and Washington, DC, area. Of 2483 individuals with confirmed severe acute respiratory syndrome coronavirus 2 infection assessed by polymerase chain reaction, those who received remdesivir were matched to infected individuals who did not receive remdesivir using time-invariant covariates (age, sex, race/ethnicity, Charlson Comorbidity Index, body mass index, and do-not-resuscitate or do-not-intubate orders) and time-dependent covariates (ratio of peripheral blood oxygen saturation to fraction of inspired oxygen, blood pressure, pulse, temperature, respiratory rate, C-reactive protein level, complete white blood cell count, lymphocyte count, albumin level, alanine aminotransferase level, glomerular filtration rate, dimerized plasmin fragment D [D-dimer] level, and oxygen device). An individual in the remdesivir group with k days of treatment was matched to a control patient who stayed in the hospital at least k days (5 days maximum) beyond the matching day. Exposures: Remdesivir treatment with or without corticosteroid administration. Main Outcomes and Measures: The primary outcome was rate of clinical improvement (hospital discharge or decrease of 2 points on the World Health Organization severity score), and the secondary outcome, mortality at 28 days. An additional outcome was clinical improvement and time to death associated with combined remdesivir and corticosteroid treatment. Results: Of 2483 consecutive admissions, 342 individuals received remdesivir, 184 of whom also received corticosteroids and 158 of whom received remdesivir alone. For these 342 patients, the median age was 60 years (interquartile range, 46-69 years), 189 (55.3%) were men, and 276 (80.7%) self-identified as non-White race/ethnicity. Remdesivir recipients had a shorter time to clinical improvement than matched controls without remdesivir treatment (median, 5.0 days [interquartile range, 4.0-8.0 days] vs 7.0 days [interquartile range, 4.0-10.0 days]; adjusted hazard ratio, 1.47 [95% CI, 1.22-1.79]). Remdesivir recipients had a 28-day mortality rate of 7.7% (22 deaths) compared with 14.0% (40 deaths) among matched controls, but this difference was not statistically significant in the time-to-death analysis (adjusted hazard ratio, 0.70; 95% CI, 0.38-1.28). The addition of corticosteroids to remdesivir was not associated with a reduced hazard of death at 28 days (adjusted hazard ratio, 1.94; 95% CI, 0.67-5.57). Conclusions and Relevance: In this comparative effectiveness research study of adults hospitalized with COVID-19, receipt of remdesivir was associated with faster clinical improvement in a cohort of predominantly non-White patients. Remdesivir plus corticosteroid administration did not reduce the time to death compared with remdesivir administered alone.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Hospitalization , Adenosine Monophosphate/therapeutic use , Aged , Alanine/therapeutic use , Baltimore , COVID-19/virology , Case-Control Studies , Comparative Effectiveness Research , District of Columbia , Female , Hospital Mortality , Humans , Male , Middle Aged , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
14.
Clin Infect Dis ; 73(11): e4124-e4130, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1012824

ABSTRACT

BACKGROUND: It is unclear whether chronic use of immunosuppressive drugs worsens or improves the severity of coronavirus disease 2019 (COVID-19), with plausible mechanisms for both. METHODS: Retrospective cohort study in 2121 consecutive adults with acute inpatient hospital admission between 4 March and 29 August 2020 with confirmed or suspected COVID-19 in a large academic health system, with adjustment for confounding with propensity score-derived stabilized inverse probability of treatment weights. Chronic immunosuppression was defined as prescriptions for immunosuppressive drugs current at the time of admission. Outcomes included mechanical ventilation, in-hospital mortality, and length of stay. RESULTS: There were 2121 patients admitted with laboratory-confirmed (1967, 93%) or suspected (154, 7%) COVID-19 during the study period, with a median age of 55 years (interquartile range, 40-67). Of these, 108 (5%) were classified as immunosuppressed before COVID-19, primarily with prednisone (>7.5 mg/day), tacrolimus, or mycophenolate mofetil. Among the entire cohort, 311 (15%) received mechanical ventilation; the median (interquartile range) length of stay was 5.2 (2.5-10.6) days, and 1927 (91%) survived to discharge. After adjustment, there were no significant differences in the risk of mechanical ventilation (hazard ratio [HR], .79; 95% confidence interval [CI], .46-1.35), in-hospital mortality (HR, .66; 95% CI, .28-1.55), or length of stay (HR, 1.16; 95% CI, .92-1.47) among individuals with immunosuppression and counterparts. CONCLUSIONS: Chronic use of immunosuppressive drugs was neither associated with worse nor better clinical outcomes among adults hospitalized with COVID-19 in one US health system.


Subject(s)
COVID-19 , Pharmaceutical Preparations , Adult , Cohort Studies , Hospital Mortality , Hospitalization , Humans , Middle Aged , Respiration, Artificial , Retrospective Studies , SARS-CoV-2
17.
Clin Transl Sci ; 14(1): 153-162, 2021 01.
Article in English | MEDLINE | ID: covidwho-883254

ABSTRACT

Many academic institutions are collecting blood samples from patients seeking treatment for coronavirus disease 2019 (COVID-19) to build research biorepositories. It may be feasible to extract pharmacogenomic (PGx) information from biorepositories for clinical use. We sought to characterize the potential value of multigene PGx testing among individuals hospitalized with COVID-19 in the United States. We performed a cross-sectional analysis of electronic health records from consecutive individuals hospitalized with COVID-19 at a large, urban academic health system. We characterized medication orders, focusing on medications with actionable PGx guidance related to 14 commonly assayed genes (CYP2C19, CYP2C9, CYP2D6, CYP3A5, DPYD, G6PD, HLA-A, HLA-B, IFNL3, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1). A simulation analysis combined medication data with population phenotype frequencies to estimate how many treatment modifications would be enabled if multigene PGx results were available. Sixty-four unique medications with PGx guidance were ordered at least once in the cohort (n = 1,852, mean age 60.1 years). Nearly nine in 10 individuals (89.7%) had at least one order for a medication with PGx guidance and 427 patients (23.1%) had orders for 4 or more actionable medications. Using a simulation, we estimated that 17 treatment modifications per 100 patients would be enabled if PGx results were available. The genes CYP2D6 and CYP2C19 were responsible for the majority of treatment modifications, and the medications most often affected were ondansetron, oxycodone, and clopidogrel. PGx results would be relevant for nearly all individuals hospitalized with COVID-19 and would provide the opportunity to improve clinical care.


Subject(s)
COVID-19/drug therapy , Pharmacogenomic Testing/methods , SARS-CoV-2 , Adult , Aged , Aged, 80 and over , COVID-19/genetics , Cross-Sectional Studies , Cytochrome P-450 CYP2C19/genetics , Cytochrome P-450 CYP2D6/genetics , Female , Hospitalization , Humans , Male , Middle Aged , Retrospective Studies
18.
JAMA Netw Open ; 3(10): e2021476, 2020 10 01.
Article in English | MEDLINE | ID: covidwho-812816

ABSTRACT

Importance: Little is known about the association between the coronavirus disease 2019 (COVID-19) pandemic and the level and content of primary care delivery in the US. Objective: To quantify national changes in the volume, type, and content of primary care delivered during the COVID-19 pandemic, especially with regard to office-based vs telemedicine encounters. Design, Setting, and Participants: Analysis of serial cross-sectional data from the IQVIA National Disease and Therapeutic Index, a 2-stage, stratified nationally representative audit of outpatient care in the US from the first calendar quarter (Q1) of 2018 to the second calendar quarter (Q2) of 2020. Main Outcomes and Measures: Visit type (office-based or telemedicine), overall and stratified by patient population and geographic region; assessment of blood pressure or cholesterol measurement; and initiation or continuation of prescription medications. Results: In the 8 calendar quarters between January 1, 2018, and December 31, 2019, between 122.4 million (95% CI, 117.3-127.5 million) and 130.3 million (95% CI, 124.7-135.9 million) quarterly primary care visits occurred in the US (mean, 125.8 million; 95% CI, 121.7-129.9 million), most of which were office-based (92.9%). In 2020, the total number of encounters decreased to 117.9 million (95% CI, 112.6-123.2 million) in Q1 and 99.3 million (95% CI, 94.9-103.8 million) in Q2, a decrease of 21.4% (27.0 million visits) from the average of Q2 levels during 2018 and 2019. Office-based visits decreased 50.2% (59.1 million visits) in Q2 of 2020 compared with Q2 2018-2019, while telemedicine visits increased from 1.1% of total Q2 2018-2019 visits (1.4 million quarterly visits) to 4.1% in Q1 of 2020 (4.8 million visits) and 35.3% in Q2 of 2020 (35.0 million visits). Decreases occurred in blood pressure level assessment (50.1% decrease, 44.4 million visits) and cholesterol level assessment (36.9% decrease, 10.2 million visits) in Q2 of 2020 compared with Q2 2018-2019 levels, and assessment was less common during telemedicine than during office-based visits (9.6% vs 69.7% for blood pressure; P < .001; 13.5% vs 21.6% for cholesterol; P < .001). New medication visits in Q2 of 2020 decreased by 26.0% (14.1 million visits) from Q2 2018-2019 levels. Telemedicine adoption occurred at similar rates among White individuals and Black individuals (19.3% vs 20.5% of patient visits, respectively, in Q1/Q2 of 2020), varied by region (low of 15.1% of visits [East North Central region], high of 26.8% of visits [Pacific region]), and was not correlated with regional COVID-19 burden. Conclusions and Relevance: The COVID-19 pandemic has been associated with changes in the structure of primary care delivery, with the content of telemedicine visits differing from that of office-based encounters.


Subject(s)
Office Visits/statistics & numerical data , Primary Health Care/statistics & numerical data , Telemedicine/statistics & numerical data , Adult , African Americans , Aged , Betacoronavirus , COVID-19 , Coronavirus Infections/epidemiology , Cross-Sectional Studies , Delivery of Health Care/statistics & numerical data , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , SARS-CoV-2 , United States/epidemiology , Young Adult
19.
BMJ Open ; 10(6): e039978, 2020 06 09.
Article in English | MEDLINE | ID: covidwho-592392

ABSTRACT

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19. DESIGN, SETTING AND PARTICIPANTS: Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO's International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers. MAIN OUTCOMES: Trial intervention, sponsorship, critical design elements and specified outcomes RESULTS: Overall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020. CONCLUSIONS: While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.


Subject(s)
Antimalarials/pharmacology , Antineoplastic Agents/pharmacology , Antiviral Agents/pharmacology , Clinical Trials as Topic , Coronavirus Infections , Immunization, Passive/methods , Immunosuppressive Agents/pharmacology , Pandemics , Plasma/immunology , Pneumonia, Viral , Betacoronavirus/isolation & purification , COVID-19 , Clinical Trials as Topic/classification , Clinical Trials as Topic/methods , Clinical Trials as Topic/standards , Clinical Trials as Topic/statistics & numerical data , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Cross-Sectional Studies , Humans , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Registries/statistics & numerical data , SARS-CoV-2 , Therapies, Investigational/methods , Therapies, Investigational/statistics & numerical data
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