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1.
JAMA Network Open ; 5(12):e2244505, 2022.
Article in English | MEDLINE | ID: covidwho-2127467

ABSTRACT

Importance: SARS-CoV-2, which causes COVID-19, poses considerable morbidity and mortality risks. Studies using data collected during routine clinical practice can supplement randomized clinical trials to provide needed evidence, especially during a global pandemic, and can yield markedly larger sample sizes to assess outcomes for important patient subgroups.

2.
Journal of Neurology, Neurosurgery and Psychiatry ; 93(Supplement 1):A69, 2022.
Article in English | EMBASE | ID: covidwho-2064254

ABSTRACT

Video consultations have become a viable alternative for face-to-face consultations during Covid19 pandemic and are expected to be used increasingly in the future. To date, there is little evidence to support the acceptability of these services or to document the benefits and challenges when offering online clinics to HD patients. Method We report on an EHDN WG Genetic Counselling and Testing project of 41 healthcare professionals from 15 European countries. Participants filled in a purposely-designed survey to assess the acceptability, benefits and challenges of telemedicine with HD affected and at risk individuals. The survey was active from March 2020 until March 2021. Results Respondents were geneticists (34%), neurologists (34%), genetic counsellors (15%), and others (psychologists, psychiatrists and research practitioners) (17%). Before the Covid-19 pandemic, professionals saw 4.5 HD patients per week and most (85%) never used telemedicine. During the pandemic, professionals saw 2.4 patients per week in face-toface consultations and 3.4 patients in online consultations. 85% of professionals felt that HD clinics can be done safely and effectively online. Most respondents agreed several aspects of consultations can be done safely online: follow-up counselling (78%), genetic counselling for predictive testing (54%), psychological assessment (49%), psychiatric and behavioural assessment (44%). The main benefits of telemedicine perceived were and challenges were also listed and discussed at length. Conclusions and discussion Our data are encouraging in relation to the potential for virtual and hybrid consultations in HD care. We draw on both quantitative and qualitative data to discuss professionals' views on telemedicine as well as potential implications for future practice.

3.
American Journal of Transplantation ; 22(Supplement 3):404, 2022.
Article in English | EMBASE | ID: covidwho-2063367

ABSTRACT

Purpose: The OPTN DTAC, a multidisciplinary group, evaluates potential donor derived transmission events (PDDTE) to assess the likelihood of disease transmission. Method(s): Retrospective study of PDDTE cases reported to the OPTN between 01/20 and 12/20. DTAC reviewed cases using a standardized classification algorithm. Result(s): During 2020, there were 18,318 donors and 37,583 unique recipients. DTAC reviewed 261/427 PDDTE from donor (111) or recipient (150) findings. 64/261 (25%) donors had proven/probable transmission (P/P Tr) of infection, malignancies or other to 84/206 (41%) exposed recipients [figure]. 12 involved living donors. Infection occurred with 44/64 P/P cases affecting 63 recipients. Viruses were most frequent P/P infections with 29 recipients having P/P Tr from 19 donors. COVID-19 PDDTE represented 11% (29/261) of all cases reviewed involving 29 donors and 15 lung and 76 non-lung recipients. One lung recipient had P/P Tr and died;none of the non-lung recipients developed P/P Tr. For bacteria, 20 recipients had P/P Tr from 14 donors. Deaths from infection (N=10) occurred at a median of 20 days (5-89 days). Attributable death was highest for fungal (4/12, 33%) and bacterial infections (6/20, 30%). 7 donors with malignancies were classified as P/P impacting 15 recipients with 1 attributable death. 53 non-infection, non-malignancy PDDTE were reported;13 resulted in P/P Tr to 14 recipients. Conclusion(s): Although P/P events remain rare, 1/4 reviewed cases resulted in unanticipated P/P Tr. This is a conservative estimate due to passive reporting and empiric interventions. In 29 COVID-19 PDDTE only 1 lung recipient had P/P Tr. The DTAC continues to evaluate PDDTE to maximize organ use and minimize the risk of transmission. (Table Presented).

4.
American Journal of Transplantation ; 22(Supplement 3):333, 2022.
Article in English | EMBASE | ID: covidwho-2063353

ABSTRACT

Purpose: Decision to transplant organs from SARS-CoV-2 NAT+ donors(N+D) balances risk of donor-derived infection with the scarcity of available organs to meet the needs of waitlisted candidates. Method(s): OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) reports on the use of organs from N+D from the onset of required SARS-CoV-2 lower respiratory tract(LRT) testing for lung donors (May 27, 2021) through August 31, 2021. OPTN data were analyzed for donors with a positive LRT or upper respiratory tract (URT) test reported in DonorNet discrete data fields (N+D), compared with donors who did not have positive LRT or URT in the discrete data fields (N-D). Result(s): Organs were recovered from 120 N+D (all OPTN Regions and 40/57 OPOs (70%)). Median donor age was 42 (IQR: 32-52) for N+D and 43 (30-56) for N-D. There was a greater proportion of DCD N+D than N-D (37.5% vs 28.3%, p=0.04). Underlying COD of anoxia and other were different (N+D 31.7%, 16.7% vs N-D 48%, 2.7%, respectively). Transplanted N+D and N-D did not differ by KDPI, LDRI or LVEF for kidney(KT), liver(LT) or heart(HT), respectively (Table 1). Median time from donor admission to first reported test (any result) was 0 and 4 days for URT and LRT, respectively. N+D recovery occurred a median of 2 (IQR: 1-6) days from last positive test. 246 organs (152KT, 50LT, 22HT, 22other) were transplanted from 107 N+D compared to 8969 organs from 3348 N-D. Recipients from N+D and N-D were similar in age, MELD/PELD (LT) and medical urgency status (HT). Median time from listing to transplant similar for N+D for all organs. The match run sequence number for final acceptor was higher for N+D for all organ types (Table 2). Median length of stay was similar for N+D and N-D for KT and LT (5d and 12-13d, respectively). For HT, median stay was shorter for N+D (30 vs 34d). For N+D, 3 of 50 LT died within 30d of transplant. During this timeframe, no PDDTEs were reported for any N+D at the time of transplant. Conclusion(s): N+D and N-D were similar in terms organ quality characteristics. Recipients receiving organs from N+D had higher match run sequence numbers, suggesting use of organs from N+D is not widespread across centers;however, with small numbers, this data will need to be verified. We cannot assess the relatedness of the three early mortality events in N+D recipients to donor or recipient characteristics. However, these data highlight the importance of ongoing outcome review of N+D recipients. (Figure Presented).

5.
Neurology ; 98(18 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1925472

ABSTRACT

Objective: To examine the temporal trends of humoral and cell-mediated immune responses to SARS-CoV-2 mRNA vaccines among multiple sclerosis (MS) patients on different immunomodulatory therapies. Background: The impact of various MS medications on the immune responses to SARS-CoV-2 vaccine is of acute interest to patients and clinicians. Design/Methods: 22 MS patients treated with ocrelizumab (OCR, n=9), natalizumab (NTZ, n=8), fumarates (FUM, n=5;diroximel fumarate, 3 and dimethyl fumarate, 2) received BNT162b2 (Pfizer, n=15) or mRNA-1273 (Moderna, n=7) vaccines. Blood samples were collected before and after each of the two vaccine doses, and 2 months after second vaccine dose. AntiSARS-CoV-2 spike protein titers were measured using quantitative assay (Labcorp). Antibody neutralization was measured with a lentivirus-based pseudovirus particle expressing the D614 spike protein (Labcorp-Monogram Biosciences). T-cell reactivity was determined by measuring interferon-gamma and interleukin-2 in response to stimulation with SARS-CoV-2 peptides. Results: All patients in NTZ and FUM cohorts, but only 22% (2/9) of OCR cohort developed anti-spike and neutralizing antibodies. The highest titers were measured after the second vaccine dose, without significant difference between the NTZ and FUM cohorts in anti-spike IgG (69.7+/-55.1 vs 56.0+/-36.7 arbitrary units/ml) or neutralizing ID50 (1513+/-1317 vs 942+/ -566). Two months after the second vaccine, the antibody titers and neutralizing ID50 decreased by 72% and 79% in NTZ cohort, respectively, and by 45% and 49% in FUM cohort. T-cell reactivity was observed in all cohorts as early as 7 days after the first vaccine, and further increased following the second vaccine. Conclusions: Patients on NTZ and FUM mounted robust antibody responses to SARS-CoV-2 mRNA vaccines, in contrast to OCR-treated patients. T-cell responses were comparable among all three treatment cohorts. Two months after the second vaccine, the serological responses decreased by 45-79%. These findings may inform the optimal timing of additional vaccine doses for MS patients.

6.
Children & Schools ; : 5, 2022.
Article in English | Web of Science | ID: covidwho-1868273

ABSTRACT

During the beginning stages of COVID-19, school social workers in New York City (NYC) were at the forefront of managing the mental health of youth and families. There were multiple barriers that interfered with the level of care that school social workers wanted and needed to provide to both students and their families. This article is an NYC school social worker's firsthand account of how she and her collaborative team managed the mental health of NYC students and families. Specifically, this article addresses suicidal ideation and suicidality in adolescents during the pandemic. This article also addresses the disparities and recommendations for further access to mental health care in NYC's racially and socioeconomically diverse school communities. The article recommends both micro and macro changes that can be implemented to better address the acute crisis and long-term trauma implications for this population. Finally, this article makes recommendations for furthering social work educational practices to better train clinicians to handle future crises.

7.
Journal of Neuropathology and Experimental Neurology ; 81(6):476-476, 2022.
Article in English | Web of Science | ID: covidwho-1866087
8.
Anesthesia and Analgesia ; 134(4 SUPPL):59, 2022.
Article in English | EMBASE | ID: covidwho-1820565

ABSTRACT

Introduction: The COVID-19 pandemic has advanced market awareness of the benefits of remote-controlled ventilators to reduce the exposure of healthcare workers to patients with COVID-19, enable more rapid and frequent ventilator setting adjustment, and preserve limited personal protective equipment. The US FDA permitted manufacturers to add remote monitoring and control capabilities to ventilators and infusion pumps through immediate in effect guidance [1,2]. When integrated with tele-critical care systems, remote control of medical devices allows distant clinical experts to collaborate with local clinicians to “virtually” manage the therapy of patients at hotspots. Core remote control capabilities can also be used by software applications to implement medical device control algorithms for Software as a Medical Device (SaMD). The US Army /TATRC launched the National Tele-Critical Care Network (NETCCN) to rapidly develop and deploy a platform to support COVID-19 disaster response [3]. We are investigating technical solutions, communication protocols, and safety assurance measures for integrating remote control of medical devices to the NETCCN systems. Methods: We developed an architecture and a prototype system (Figure 1) to investigate safety, security, and interoperability requirements for integration of remote control of medical devices with tele-critical care systems. The prototype system is based on OpenICE [4], an open-source interoperability platform developed by our program to transmit data and control medical devices at the patient's bedside. Customized interfaces (hardware and software) translate device proprietary protocols to ISO/IEEE 11073-10101 terminology over DDS middleware. Remote control applications of devices connected to OpenICE are implemented as either stand-alone OpenICE apps, which can be deployed inside or immediately outside the patient's room, or as web-based apps, which can be launched from any location to communicate with the OpenICE system. We refer to the former as “nearpatient remote control”, which may be at the bedside or co-located outside the room, and the latter as “far remote” control where the operator does not have physical access to the patient or medical equipment. Our prototype system uses the RTI Web Integration Service [5] to enable web-based control applications to communicate with the connected devices. Results: The generic architecture in Figure 1 is device agnostic: it can be used with critical care ventilators, IV infusion pumps, and other devices, provided that the device interfaces support remote control. As a proof of concept, we applied this architecture to a Q Core Sapphire IV infusion pump using a non-clinical control interface, and confirmed that the infusion rate could be adjusted by both near-patient and far remote (web) control applications with generally acceptable delays (3∼8 seconds from remote control action until the pump executes the change). This prototype system allows the exploration and validation of risks associated with medical device remote control in the tele-critical care context. An example of a risk identified in our study relates contention between near and far “loci of control”. Unexpected device behavior can occur if there is no mechanism to 1) explicitly prioritize loci of control that may occur simultaneously (e.g., always prioritize local control over far control to enable the local provider to regain control or prevent remote control);and 2) clearly indicate where the locus of control resides. Other risks may arise due to issues related to cybersecurity, network QoS, permission for remote control, and usability (e.g., use errors associated with far remote control due to the lack of a real-time view of the patient). We are collaborating with the AAMI InterOperability Working Group (IOWG) to share the experience and lessons learned in this effort to develop a safety standard for medical device remote control, and with other performers in the NETCCN portfolio. (Figure Presented).

9.
Open Forum Infectious Diseases ; 8(SUPPL 1):S77, 2021.
Article in English | EMBASE | ID: covidwho-1746783

ABSTRACT

Background. T cells are central to the early identification and clearance of viral infections and support antibody generation by B cells, making them desirable for assessing the immune response to SARS-CoV-2 infection and vaccines. We combined 2 high-throughput immune profiling methods to create a quantitative picture of the SARS-CoV-2 T-cell response that is highly sensitive, durable, diagnostic, and discriminatory between natural infection and vaccination. Methods. We deeply characterized 116 convalescent COVID-19 subjects by experimentally mapping CD8 and CD4 T-cell responses via antigen stimulation to 545 Human Leukocyte Antigen (HLA) class I and 284 class II viral peptides. We also performed T-cell receptor (TCR) repertoire sequencing on 1815 samples from 1521 PCR-confirmed SARS-CoV-2 cases and 3500 controls to identify shared public TCRs from SARS-CoV-2-associated CD8 and CD4 T cells. Combining these approaches with additional samples from vaccinated individuals, we characterized the response to natural infection as well as vaccination by separating responses to spike protein from other viral targets. Results. We find that T-cell responses are often driven by a few immunodominant, HLA-restricted epitopes. As expected, the SARS-CoV-2 T-cell response peaks about 1-2 weeks after infection and is detectable at least several months after recovery. Applying these data, we trained a classifier to diagnose past SARS-CoV-2 infection based solely on TCR sequencing from blood samples and observed, at 99.8% specificity, high sensitivity soon after diagnosis (Day 3-7 = 85.1%;Day 8-14 = 94.8%) that persists after recovery (Day 29+/convalescent = 95.4%). Finally, by evaluating TCRs binding epitopes targeting all non-spike SARS-CoV-2 proteins, we were able to separate natural infection from vaccination with > 99% specificity. Conclusion. TCR repertoire sequencing from whole blood reliably measures the adaptive immune response to SARS-CoV-2 soon after viral antigenic exposure (before antibodies are typically detectable) as well as at later time points, and distinguishes post-infection vs. vaccine immune responses with high specificity. This approach to characterizing the cellular immune response has applications in clinical diagnostics as well as vaccine development and monitoring.

10.
Open Forum Infectious Diseases ; 8(SUPPL 1):S808-S809, 2021.
Article in English | EMBASE | ID: covidwho-1746275

ABSTRACT

Background. Interventions to reduce mortality in critically ill patients with COVID-19 are a crucial unmet medical need. Baricitinib (BARI) is an oral, selective Janus kinase (JAK)1/JAK2 inhibitor with efficacy in hospitalized adults with COVID-19. Treatment with BARI 4-mg was evaluated in critically ill adult patients with COVID-19 with baseline need for invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Methods. COV-BARRIER (NCT04421027) was a randomized double-blind, placebo-controlled trial in patients with confirmed SARS-CoV-2 infection and elevation of ≥ 1 serum inflammatory marker. In this newly completed substudy, enrolled participants (not previously reported) from 4 countries on IMV or ECMO at study entry were randomly assigned 1:1 to once-daily BARI 4-mg or placebo (PBO) for up to 14 days plus standard of care (SOC), which included baseline systemic corticosteroid use in 86% of patients. The prespecified exploratory endpoints included all-cause mortality and number of ventilator-free days (VFDs) through Day 28. Results. Characteristics for 101 participants are shown in Table 1. Treatment with BARI significantly reduced all-cause mortality by Day 28 compared to PBO [39.2% vs 58.0%, respectively;hazard ratio (HR) = 0.54 (95%CI 0.31, 0.96), p=0.030, relative risk (RR) = 0.68 (95%CI 0.45, 1.02);Figure 1A]. One additional death was prevented for every six BARI-treated patients. Significant reduction in mortality was also observed by Day 60 [45.1% vs 62.0%;HR = 0.56 (95%CI 0.33, 0.97), p=0.027, RR = 0.73 (95%CI 0.50, 1.06);Figure 1B]. Patients treated with BARI showed a numerical reduction in the duration of IMV and duration of hospitalization vs PBO and more BARI treated patients recovered (Table 2). No new safety findings were observed (Table 2). Conclusion. Treatment with BARI+SOC (corticosteroids) resulted in an absolute risk reduction in mortality of 19% at Day 28 and 17% at Day 60 in patients with COVID-19 who were on IMV or ECMO at enrollment. These results are consistent with the reduction in mortality observed in the less severely ill hospitalized patients in the primary COV-BARRIER study population.

11.
Critical Care Medicine ; 50(1 SUPPL):43, 2022.
Article in English | EMBASE | ID: covidwho-1692107

ABSTRACT

INTRODUCTION: The National Emergency Tele-Critical Care Network (NETCCN) was developed to address limited and geographically unevenly distributed critical care (CC) providers during COVID-19 pandemic surges. Although designed for on-demand access to CC experts, for pandemic response, NETCCN continues to evolve and must be flexible and adaptable to future mass casualty/disasters. We report a pilot using tele-critical care (TCC) through NETCCN in emergency medical services (EMS). METHODS: We deployed a mobile device enabled cloud based, easy to use and learn, secure, HIPAA compliant TCC app developed for NETCCN in an emergency medical services (EMS) pilot designed to facilitate rapid communication via text, voice, video and file sharing between paramedics in the field, and emergency medicine specialists. A 30-minute session trained participants on the app, including account creation, login, and functions. EMS providers were encouraged to replace existing telephone communication triage protocols with the NETCCN mobile app. We collected the number/nature of consults, and narrative feedback. RESULTS: The pilot ran for 30 days and was used on average 3 times/week. No patient data was entered into the system, and the app was solely used for its communication features. The most common use case was terminating resuscitation. Debrief and feedback confirmed that the app was easy to use, not significantly affected by connectivity issues, and elicited several barriers to adoption by EMS providers: 1) manual input of patient data 2) perception of being micromanaged. Overall impression of the app and its utility was positive by both remote and EMS providers, and discussion elicited strategies to improve adoption: 1) incorporate TCC into protocols for interfacility critical care transport 2) automate patient data entry (e.g. scan driver's license)). CONCLUSIONS: We demonstrated that the NETCCN TCC app is quickly and easily usable in the EMS setting, but that further optimization is required to promote adoption. Novel non-disaster use cases like this can provide means to stabilize and sustain a system designed primarily for infrequent “as needed” response. Additionally, feedback and problem solving for these novel use cases can be an effective way to enhance system flexibility with dividends for future disaster use.

12.
AEE World Energy Conference and Expo 2021 ; : 962-1000, 2021.
Article in English | Scopus | ID: covidwho-1567486
13.
American Journal of Transplantation ; 21(SUPPL 4):351, 2021.
Article in English | EMBASE | ID: covidwho-1494443

ABSTRACT

Purpose: US Solid organ transplantation rates significantly decreased during the initial wave of the COVID-19 pandemic. The concern for potential donor derived COVID-19 was one of many contributing factors. We describe the early experience of the Organ Procurement and Transplantation Network (OPTN) Disease Transmission Advisory Committee (DTAC) Coronavirus disease 2019 (COVID-19) investigations. Methods: COVID-19 cases reported to DTAC between January 2020 and October 2020 as potential donor-derived transmission events (PPDTE) were included. All of the events were investigated by the Centers for Disease Control and Prevention and adjudicated by the DTAC based on consensus definitions. Results: Eighteen PDTE COVID-19 events were reported during the study period. 12 PDTE reports have completed DTAC adjudication (Table 1). These included 12 donors with 44 recipients. Ten investigations were initiated by the transplant center due to recipient testing (36 total recipients). The median time to presentation in these index cases was 11 days (IQR 7-16). Nine donors in these events (35 recipients) had a prospective or retrospective pre-recovery negative SARS-CoV-2 PCR result. In all of these events, the index recipient had either a possible or confirmed community or hospital exposure. In one recipient index case (5 total recipients), the positive SARS-CoV-2 PCR result post-transplant was ultimately deemed a false positive and considered not a case by the committee. Two investigations were initiated by an OPO (8 recipients). In both events, the OPO performed SARS-CoV-2 PCR was negative, but a post-procurement nasopharyngeal SARS-CoV-2 PCR performed by the tissue collector was reported as positive and retrospectively deemed false positives. None of these recipients developed COVID-19;the events were adjudicated as not cases. Conclusions: The initial DTAC experience reflecting the early pandemic era emphasizes the need to implement hospital prevention measures to avoid nosocomial transmission, provide patient education to avoid community exposure and to recognize the possibility of post-procurement SARS-CoV-2 false positive testing. Vigilance for the possibility of a SARS-CoV-2 donor derived event remains important as the pandemic continues. (Table Presented) .

17.
Open Forum Infectious Diseases ; 7(SUPPL 1):S293, 2020.
Article in English | EMBASE | ID: covidwho-1185812

ABSTRACT

Background: First responders (e.g., emergency medical technicians, firefighters and police) may be at higher risk of SARS-CoV-2 infection and potentially spreading it than the general population due to frequent and close exposure to others. Prevention of first responder infections is important for reducing secondary transmission and maintaining health system capacity. We aimed to evaluate the burden of SARS-CoV-2 infection on first responders, identify risk factors for infection, and to provide health services to help control the current outbreak. Methods: Memorial Healthcare System (MHS), a public healthcare system serving the South Broward Hospital District, together with the National Guard and Florida state governor, opened up a drive-through testing center for SARS-CoV-2 at C.B. Smith Park in Broward County, Florida. All first responders in Broward County, symptomatic or asymptomatic, were being tested. SARS-CoV-2 infection was made as a positive result of real time polymerase chain reaction (PCR) testing on at least one nasal or nasopharyngeal swab. All first responders who test positive for SARS-CoV-2 were informed by test site staff and self-quarantined to limit the spread of the disease. Results: A total of 3,375 individuals was tested during the period from April 1 to April 29, 2020. The median age was 42 years (IQR 33-52) and 1,464 (43%) were men. 473 (14%) were symptomatic and 2,902 (86%) were asymptomatic. 289 (8.5%) of 3,375 first responders were positive for SARS-CoV-2 infection. These included 54 of 473 symptomatic (11%) and 235 of 2,902 asymptomatic (8.1%) cases. The rates of SARS-CoV-2 infection were comparable in male vs female (8.1% vs 8.9%, p = 0.429) and in symptomatic vs asymptomatic (p = 0.173). There is no sex-, age-based differences in susceptibility to SARS-CoV-2 infection among the first responders tested (Figure 1). Laboratory confirmed SARS-CoV-2 among first responders between April 1 and April 30, 2020 in Broward County. Conclusion: First responders carry a significant burden from SARS-CoV-2 infection, with an infection rate of 8.5%, which was comparable in symptomatic and asymptomatic individuals. There is no sex-, age-based differences in susceptibility to SARS-CoV-2 infection in first responders. High priority testing for SARS-CoV-2 must expand to include first responders, particularly asymptomatic individuals.

18.
Psychoanalytic Perspectives ; 18(1):149-155, 2021.
Article in English | Scopus | ID: covidwho-1061306

ABSTRACT

In Global Perspectives, we bring you interviews with psychoanalysts from around the world in an effort to explore the influence of culture, politics, and socioeconomics on psychoanalytic training, theory development, clinical technique, and psychoanalytic practice in general. © Copyright © 2021 National Institute for the Psychotherapies.

19.
Hepatology ; 72(1 SUPPL):279A, 2020.
Article in English | EMBASE | ID: covidwho-986086

ABSTRACT

Background: Remdesivir (RDV), a nucleotide analogue prodrug that inhibits viral RNA polymerases, has demonstrated potent in vitro and in vivo activity against SAR-CoV-2 and favorable clinical efficacy and tolerability in patients with moderate and severe COVID-19 Elevated transaminase levels are commonly seen in patients with severe COVID-19 prior to treatment Here we report safety and clinical outcomes after RDV treatment in patients with normal versus elevated baseline alanine aminotransferase (ALT) levels Methods: We conducted a randomized, open-label, phase 3 trial, involving hospitalized patients with confirmed COVID-19 pneumonia with Sat<94% Patients with screening ALT or AST> 5x the upper limit of normal (ULN) were excluded from the study Patients were randomized 1:1 to receive either 5 or 10 days of intravenous RDV once daily We compared patients with baseline ALT below and above the ULN based on AASLD criteria (ALT 35 U/L for males and 25 U/L for females) Covariates for adjustment included age, sex, race and baseline oxygen support Clinical recovery and all-cause mortality were evaluated using logistic regression Clinical outcomes and adverse events (AEs) were assessed through day 28 Results: Of 397 patients treated with RDV, 215 (54%) had elevated baseline ALT Median ALT was 53 U/L (IQR: 40 - 78 U/L) in the high ALT group Patients with high ALT at time of RDV initiation were younger (median 58 vs 65 years, p<0 001), required less oxygen (p=0 02), and had longer symptom duration (median 10 vs 8 days, p<0.001) prior to first dose of RDV. Incidence of serious AEs, grade ≥3 AEs, and AE leading to discontinuation were similar between groups (Table1). Grade ≥3 hepatobiliary adverse events, particularly transaminase elevations, were not common but numerically higher in the high ALT group (8 8% vs 3 3%, p=0 068) Time to clinical recovery, 2-point clinical improvement, 1-point clinical improvement, room air, and death were similar between groups Conclusion: In severe COVID-19 patients, adverse events and clinical outcomes after RDV initiation were similar among patients with baseline normal ALT and those with elevated ALT (1-5x ULN)(Table Presented).

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