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Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients

Ulrich, Robert J; Troxel, Andrea B; Carmody, Ellie; Eapen, Jaishvi; Bäcker, Martin; DeHovitz, Jack A; Prasad, Prithiv J; Li, Yi; Delgado, Camila; Jrada, Morris; Robbins, Gabriel A; Henderson, Brooklyn; Hrycko, Alexander; Delpachitra, Dinuli; Raabe, Vanessa; Austrian, Jonathan S; Dubrovskaya, Yanina; Mulligan, Mark J
Background/UNASSIGNED:Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. Methods/UNASSIGNED:We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. Results/UNASSIGNED: = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. Conclusions/UNASSIGNED:In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.
PMID: 33134417
ISSN: 2328-8957
CID: 4655862

Diagnosing mycobacterium tuberculosis bacteremia in an immunocompromised female [Meeting Abstract]

Kassapidis, V; Jrada, M; Aye, M
LEARNINGOBJECTIVE #1: Assess the various diagnostic modalities used to diagnose Mycobacterium Tuberculosis LEARNING OBJECTIVE #2: Recognize the importance of a timely diagnosis and the utility of mycobacterial blood cultures CASE: A 67-year-old female with a past medical history of psoriasis on adalimumab therapy presented with worsening chills, fever, and a nonproductive cough for the past month. She denies any hemoptysis or night sweats but states she has had a 30-pound weight loss over the past two months. In the ED, she was afebrile, normotensive, and was saturating 95% on room air. A Chest X-ray was notable for bilateral miliary nodules. A CT scan of her chest and abdomen was then done and showed extensive miliary lesions in her lungs and spleen. She was placed on airborne isolation and admitted to the medicine service for further workup. Over the course of her hospital stay, the patient's lab work was significant for a negative fungal workup as well as a negative QuantiFERON Gold assay. Inflammatory markers and hepatic markers, specifically alkaline phosphatase and GGTP, were elevated. MRCP was then done and was notable for hepatic lesions. Sputum AFB stain and culture were collected and acid fast bacilli were noted on day 1 with PCR positive for MTB. RIPE therapy was initiated immediately. Due to the extent of extrapulmonary manifestations, blood cultures were sent for AFB staining. A month later, they returned positive for Mycobacterium Tuberculosis. IMPACT/DISCUSSION: Mycobacterium Tuberculosis is a communicable disease that is one of the top 10 causes of death worldwide. The timely diagnosis of TB is important due to treatment options and new drug resistance. A QuantiFERON Gold blood assay is used to detect TB, but does not differentiate latent from active disease. In order to diagnose a patient with active TB, confirmation via diagnostic microbiology, specifically the presence of acid-fast bacilli on sputum smear and a positive culture, is needed. Twenty percent of patients with active TB can have negative blood assay results. Therefore, with concern for extrapulmonary TB, a negative blood assay should not dissuade practitioners from obtaining blood and sputum cultures. Hematogenous dissemination of TB should be suspected in patients with presumed miliary TB and warrants the collection of mycobacterial blood cultures.MTB bacteremia is especially common in immunocompromised adults with extrapulmonary tuberculosis. While blood cultures can assist in the diagnosis of tuberculosis, growth can take up to 6 weeks and treatment should not be withheld until blood cultures result.
CONCLUSION(S): Here we present a case of an immunocompromised female with miliary TB with a negative QuantiFERON Gold assay but with positive mycobacterium tuberculosis blood cultures. QuantiFERON Gold assay can be used to help rule in or rule out TB, but not to establish a diagnosis. When patients present with extrapulmonary manifestations, blood cultures can confirm a diagnosis, especially when patients lack pulmonary manifestations on radiographic imaging
ISSN: 1525-1497
CID: 4805242

Hepatitis c screening within a large fqhc network in Brooklyn, New York: How we measure across an ethnically diverse population [Meeting Abstract]

Hayon, J; Dapkins, I; Shahin, G; Colella, D; Jrada, M; Bhakta, D; Pasco, N A
Background. With over 100,000 unique lives and 600,000 visits in 2018, The Family Health Centers at NYU Langone (FHC) is one of the largest Federally Qualified Health Center network based primarily in Southwest Brooklyn New York. Within the catchment area 48% of the population report being born out of the United States, with 30% of the population describing themselves of Asian ethnicity and 42% as Latino [1]. Effective January 1, 2014 New York State law mandated hepatitis C screening to be offered to every individual born between 1945 and 1965 receiving health services. Now five years later, with the advancements in treatment options and increased access for patients where cost has become prohibitive we retrospectively reviewed how our performance has been prior to embarking on a goal of 60% screening compliance. Methods. We performed a retrospective chart review looking at a denominator of patients born between 1945 and 1965 who were seen in the FHC for a visit in 2018. Patients who were previously screened since 2016, have a diagnosis of hepatitis C, history of hepatitis C documented in either past medical history, problem list or ICD code were excluded. Data abstraction for compliance in the numerator included patients who have a resulted hepatitis C antibody or have indicated current treatment (with a hepatitis C viral load). Results. 51% of patients based on the aforementioned methodology have been screened in 2018. 11,577 patients were eligible with 650 patients having a documented refusal. 261 new diagnosis were made in 2018 and compliance for non-screened patients without any prior screening was 35%. Regarding racial/ethnic composition of the practice sites compared with patients screened, one practice site with an 87% Asian non-Hispanic population had a 35% compliance rate with screening where as the most predominate Hispanic population site (81% of total patients seen) had a 54% compliance rate. Conclusion. Overall screening rates within the network are commendable, yet more work is being done to drive provider awareness on the need for compliance. Differences in racial/ethnic backgrounds and compliance of screening completion can be seen within the FHC network. Current efforts are focused on increasing culturally appropriate awareness amongst the patient population as well as the providers
ISSN: 2328-8957
CID: 4295892

Symptomatic copper deficiency in a patient with remote gastric bypass surgery [Meeting Abstract]

Atkinson, E C; Jrada, M; Aye, M; Okamura, C
Learning Objective #1: Recognize vitamin deficiencies in a gastric bypass patient Learning Objective #2: Treat copper deficiency CASE: A 61 year old female with a past medical history of depression, hypothyroidism, dementia, profound insomnia, and remote history of gastric bypass presented with chronic dizziness and orthostatic hypotension with recurrent falls. She had multiple hospital admissions for dizziness, gait instability and falls. Associated symptoms included nausea and vomiting, fatigue, weakness, hypotension, hypoglycemia with low insulin levels, and worsening tingling and numbness in both legs. She denied using zinc containing denture cream or cold tablets. In the ED, her vital signs were stable and blood work was significant for pancytopenia, with a WBC count of 2.2, hemoglobin of 9.4 and platelets of 137. The levels of many vitamins and minerals were checked given her history of gastric bypass and she was found to have a normal iron level with transferrin saturation of 33%, normal levels of vitamins B1, B6, B9, B12, and selenium (58) and low levels of copper, ceruloplasmin, zinc, and vitamin D. CT and MRI of the brain were negative for acute pathology but significant for severe left temporal atrophy and overall global volume loss. Following admission, she was given intravenous fluids for persistent hypotension with eventual resolution after increasing her home dose of fludrocortisone and starting her on vitamin supplementation for her noted deficiency. She was discharged on a multivitamin with minerals daily, 50,000 units of Vitamin D weekly, 220mg of zinc sulfate twice daily, and 4mg of copper three times a day with close bariatric specialist follow up. IMPACT/DISCUSSION: Copper plays an essential role in the synthesis of many proteins and its deficiency can cause a variety different symptoms. Symptomatic copper deficiency is rare but can be seen in patients with a remote history of bariatric surgeries. In these patients, absorption of many minerals, including copper, is disrupted and supplementation may be necessary to prevent deficiency. This patient had been suffering from pancytopenia with a normal iron panel, which can be due to copper deficiency. Copper is a required cofactor in iron oxidation during hematopoiesis and its deficiency therefore Results in anemia. Patients with hypocupremia may present with gait abnormalities from myelopathy, as noted in our patient. Additionally, imaging showed cerebral atrophy, possibly related to demyelination, which can be seen in patients with Menkes Disease, a mutation causing defects in copper absorption. Despite having these symptoms for years, her copper levels had not been checked prior, which delayed the diagnosis of copper deficiency.
Conclusion(s): Many of the symptoms of copper deficiency are nonspecific, which may delay diagnosis until after many hospital re-admissions. It is essential to always consider copper deficiency in a patient with chronic neurologic symptoms and anemia with a remote history of gastric bypass surgery
ISSN: 1525-1497
CID: 4052812

How primary care residents working with pharmacy teams can help address hedis measures while educating resident providers on the importance of medication adherence in the ambulatory setting [Meeting Abstract]

Chacko, M; Lee, Y S; Jrada, M; Attina, T; ValderramaTorres, O; Anzisi, L; Shull, M; Oh, J; Dapkins, I; Pasco, N A
Statement of Problem Or Question (One Sentence): As healthcare delivery shifts to the value based paradigm how do you educate primary care providers on medication adherence metrics while performing a meaningful educational experience? Objectives of Program/Intervention (No More Than Three Objectives): 1.Educate Internal Medicine residents in a Primary Care residency program on NCQA HEDIS measures regarding medication adherence metrics 2.Work with a clinically integrated network (CIN) pharmacy team on identifying patients who have not refilled their medications, and how to engage patient medication adherence Description of Program/Intervention, Including Organizational Context (E.G. Inpatient Vs. Outpatient, Practice or Community Characteristics): The Family Health Centers (FHC) at NYU Langone is a network of 8 Federally Qualified Health Centers in Brooklyn New York. Primary care residents, working with the NYU CIN pharmacy team, collaborated on telephonic outreach to engage patients identified by payor contracts as nonadherent on medication refills. After initial training, which included education on how the Proportion of Days Covered (PDC) rate is a quantitative metric used to measure quality of care and scripted exercise on telephonic patient engagement, residents were tasked with identifiying challenges on medication refill as well as intervening when appropriate. At the end of the intervention period a resident focus group was conducted to determine the educational value in this quality initiative. Measures of Success (Discuss Qualitative And/Or Quantitative Metrics Which Will Be Used To Evaluate Program/Intervention): Primary endpoint was increased PDC rates based on payor data for patients who are diagnosed with either having diabetes (non gestational), hypertension or dyslipidemia. A post intervention focus group and semantical content analysis was performed regarding educational value from this exercise. Findings To Date (It Is Not Sufficient To State Findings Will Be Discussed): In a 6-month period 523 unique patients were engaged with 899 outreaches completed. 1061 barriers were identified. The top 3 patient identified barriers were: patients unaware they had not filled the prescription (31.05%), lack of clearly identified reason for non adherence (20.23%), and patients did not feel committed to taking the prescribed medication (14.97%). When comparing PDC rates from the previous year, this intervention saw a 7% increase in aggregate PDC rates for those who were prescribed medications and having diabetes. Regarding post intervention focus groups with residents, semantic content analysis revealed the highest affinity for positive descriptors in the domains of educational value, need to expand education to resident providers, and continued interest in future quality projects with the pharmacy team. Key Lessons For Dissemination (What Can Others Take Away For Implementation To Their Practice Or Community?): Key take home lessons in this intervention is that telephonic pharmacy adherence outreach has a positive impact on maintaining PDC rate compliance, particularly in patients with managed Medicare plans. On educational value, further development is needed in resident curriculum regarding medication adherence and reconciliation in the ambulatory setting. Lastly residents working with pharmacy teams find value in addressing medication adherence barriers and may impact best practices in provider prescribing habits when engaging patients
ISSN: 1525-1497
CID: 4052922

Let's step up the war on superbugs in our hospitals: Evaluating Methods to reduce stethoscope contamination [Meeting Abstract]

Moussa, M; Jrada, M; Otuonye, A; Hayon, J; Phillips, M
Background: Stethoscopes are recognized as a culprit of microbes that has been conclusively demonstrated to transmit microbes from one patient to another and from health care worker to patient. To curb infections, hospitals need to set more rigorous hygiene standards, identify Methods to interrupt transmission and develop strategies on sterilizing the diaphragms of the stethoscopes. Furthermore, studies have shown that providers infrequently clean their stethoscopes. In one study, only 48% of providers cleaned their stethoscopes daily or weekly, 37% monthly and 7% reported that they had never cleaned their stethoscope. The objective of this study was to conduct a pilot study comparing efficacy of disposable diaphragm covers to no intervention, defined as their ability to reduce colony count of Methicillin Resistant Staphylococcus Aureus (MRSA) and reduce bacterial contamination on stethoscope diaphragm surfaces.
Method(s): This was a prospective pilot study using a randomized, controlled, single-blinded, crossover trial design, evaluating the effect of daily stethoscope disposable diaphragm covers vs. uncovered stethoscopes. Upon recruitment, residents on clinical rotations were randomized to receive one of two sealed opaque boxes. If a resident was randomized to the intervention arm, the package included instructions to begin with the covers. If a resident was randomized to the control arm, instructions were to begin with no covers. We instructed the participants to switch arms at 7 days. Laboratory Methods: A sterile swab was rolled over the surface of the stethoscope's diaphragm from side to side in a streaking method. We used the chromagar MRSA plates (MRSASelectTM II agar plates) to grow oxacillin resistant, non-enterococal gram positives and the non-selective blood agar plate. Cultures were obtained from each resident's stethoscope diaphragm at the end of every 7 day period. We performed a colony count in 24 hours and 48 hours of incubation.
Result(s): We enrolled 37 residents, of whom 29 (70%) completed both weeks of the trial. On the log-10 scale, the mean (range) colony count on plain agar was 1.5 (0.0-3.7) during control and 1.6 (0.0-3.0) using covers. For MRSA, the mean (range) log-10 colony count during control was 0.1 (0.0-2.7) and 0.1 (0.0-1.2) under covers. Overall, 7 (11%) cultures were positive for MRSA during control and 6 (9%) using covers. Using mixed models to account for within-subject and within-culture correlation, the covers increased colony count by 0.47 (95% confidence interval,-0.37-1.31) in mean log-10 overall colony count, and increased risk of MRSA+ culture by 0.2 percent (95% confidence interval,-10.0-10.3).
Conclusion(s): This well designed study shows disposable diaphragm covers inadequate in reducing bacterial load. It is likely that this study was hindered by a small sample size, therefore a larger study to evaluate the ability of other Methods to prevent cross transmission of MRSA and subsequent infections from the stethoscope diaphragm is needed
ISSN: 1525-1497
CID: 4053152

Flaccid paralysis as a complication of neuroinvasive west nile virus [Meeting Abstract]

Jrada, M; Kovacs, B; Osman, F
Learning Objective #1: Diagnose West Nile Virus (WNV) encephalitis Learning Objective #2: Recognize neurologic symptoms seen in Neuro-invasive WNV CASE: A 79 year old male with a past medical history of CAD s/p CABG, hypertension and hyperlipidemia presented with a 4 day history of generalized weakness, fevers, decreased oral intake, and confusion. He was accompanied by his wife, who denied any respiratory, skin or urologic changes, and reported the patient had been at baseline, tending his garden a couple of days prior. He had no recent travel, but had a sick contact in a grandchild who was diagnosed with an unknown virus. Upon admission, he was febrile to 39.5C, hypotensive to 95/43 with otherwise normal vital signs. Exam was notable for lethargy and proximal muscle weakness with diffuse hyporeflexia. CT scan of the head, chest X-Ray and urinalysis did not show acute abnormalities. He was started on antibiotics to cover for meningitis with improvement in his vitals, but not his mental status. The following day, a lumbar puncture was performed and cell count was notable for a white blood cell count of 344 with 76% neutrophils, 97 protein and 53 glucose, and negative gram stain. His course was complicated by an aspiration event that resulted in hypoxia and he was subsequently intubated. Additional CSF studies were then sent to the state lab, returning positive for WNV IgM the following week. The patient's hospital course was again complicated by a second aspiration event post extubation and required reintubation and eventually a tracheostomy and PEG placement. He continued to exhibit proximal and distal muscle weakness and an EMG was performed, which showed axonal and demyelination sensorimotor polyneuropathy. MRI of the spine showed enhancement of cauda equina consistent with Guillain Barre syndrome (GBS). Patient was started on plasmapheresis with improvement in his weakness. IMPACT/DISCUSSION: The key aspect of this case was the atypical appearance of acute flaccid paralysis, a Guillain Barre-like picture, that developed in a case of confirmed West Nile Virus infection. Prior to 1996, WNV was associated with typical B symptoms. Following the NYC outbreak, neurological complications, including muscle weakness, became common. Another key point is the presentation difference between normal GBS and the flaccid paralysis seen in WNV infection. In standard GBS, weakness typically begins weeks after infection, while weakness in WNV occurs in the acute to subacute phase. As was present in this case, leukocytosis and elevated protein in CSF are both characteristic of WNV infection while typical GBS CSF shows elevated protein without leuko-cytosis, the classic albuminocytologic dissociation. While WNV-associated paralysis is a well-described phenomenon, it has not become commonplace knowledge in general medicine.
Conclusion(s): WNV often presents as a non-specific encephalitis that may be misdiagnosed as a bacterial pneumonia. It is imperative that WNV be part of the differential in an acutely ill patient presenting with muscle weakness
ISSN: 1525-1497
CID: 4053202


Dapkins, Isaac; Jrada, Morris; Schubert, Finn D.; Muzib, Abdulrahman; Pasco, Neil A.
ISSN: 0884-8734
CID: 4407922