Browsing by Author "Harahsheh, Ashraf S."

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    Infliximab versus second intravenous immunoglobulin for treatment of resistant Kawasaki disease in the USA (KIDCARE): a randomised, multicentre comparative effectiveness trial
    (Elsevier, 2021-12) Burns, Jane C.; Roberts, Samantha C.; Tremoulet, Adriana H.; He, Feng; Printz, Beth F.; Ashouri, Negar; Jain, Supriya S.; Michalik, David E.; Sharma, Kavita; Truong, Dongngan T.; Wood, James B.; Kim, Katherine K.; Jain, Sonia; Anand, Vikram; Anderson, Marsha; Ang, Jocelyn; Ansusinha, Emily; Arditi, Moshe; Bartlett, Allison; Baker, Annette; Chatterjee, Archana; DeBiasi, Roberta; De Ferranti, Sarah; Dekker, Cornelia; DeZure, Chandani; Dominguez, Samuel; Erdem, Guliz; Halasa, Natasha; Harahsheh, Ashraf S.; Hite, Michelle; Jaggi, Preeti; Jone, Pei-Ni; Jones, Jessica; Kaushik, Neeru; Kumar, Madan; Kurio, Gregory; Lloyd, David; Manaloor, John; McNelis, Amy; Nadipuram, Santhosh; Newburger, Jane; Newcomer, Charles; Perkins, Tiffany; Portman, Michael; Romero, José R.; Rometo, Allison; Ronis, Tova; Rosenkranz, Margalit; Rowley, Anne; Samuy, Nichole; Scalici, Paul; Schuster, Jennifer; Sexson Tejtel, S. Kristen; Simonsen, Kari; Szmuszkovicz, Jacqueline; Yeh, Sylvia; Pediatrics, School of Medicine
    Background Although intravenous immunoglobulin (IVIG) is effective therapy for Kawasaki disease, 10–20% of patients have recrudescent fever as a sign of persistent inflammation and require additional treatment. We aimed to compare infliximab with a second infusion of IVIG for treatment of resistant Kawasaki disease. Methods In this multicentre comparative effectiveness trial, patients (aged 4 weeks to 17 years) with IVIG resistant Kawasaki disease and fever at least 36 h after completion of their first IVIG infusion were recruited from 30 hospitals across the USA. Patients were randomly assigned (1:1) to second IVIG (2 g/kg over 8–12 h) or intravenous infliximab (10 mg/kg over 2 h without premedication), by using a randomly permuted block randomisation design with block size of two or four. Patients with fever 24 h to 7 days following completion of first study treatment crossed over to receive the other study treatment. The primary outcome measure was resolution of fever at 24 h after initiation of study treatment with no recurrence of fever attributed to Kawasaki disease within 7 days post-discharge. Secondary outcome measures included duration of fever from enrolment, duration of hospitalisation after randomisation, and changes in markers of inflammation and coronary artery Z score. Efficacy was analysed in participants who received treatment and had available outcome values. Safety was analysed in all randomised patients who did not withdraw consent. This clinical trial is registered with ClinicalTrials.gov, NCT03065244. Findings Between March 1, 2017, and Aug 31, 2020, 105 patients were randomly assigned to treatment and 103 were included in the intention-to-treat population (54 in the infliximab group, 49 in the second IVIG group). Two patients randomised to infliximab did not receive allocated treatment. The primary outcome was met by 40 (77%) of 52 patients in the infliximab group and 25 (51%) of 49 patients in the second IVIG infusion group (odds ratio 0·31, 95% CI 0·13–0·73, p=0·0076). 31 patients with fever beyond 24 h received crossover treatment: nine (17%) in the infliximab group received second IVIG and 22 (45%) in second IVIG group received infliximab (p=0·0024). Three patients randomly assigned to infliximab and two to second IVIG with fever beyond 24h did not receive crossover treatment. Mean fever days from enrolment was 1·5 (SD 1·4) for the infliximab group and 2·5 (2·5) for the second IVIG group (p=0·014). Mean hospital stay was 3·2 days (2·1) for the infliximab group and 4·5 days (2·5) for the second IVIG group (p<0·001). There was no difference between treatment groups for markers of inflammation or coronary artery outcome. 24 (44%) of 54 patients in the infliximab group and 33 (67%) of 49 in the second IVIG group had at least one adverse event. A drop in haemoglobin concentration of at least 2g/dL was seen in 19 (33%) of 58 patients who received IVIG as either their first or second study treatment (three of whom required transfusion) and in three (7%) of 43 who received only infliximab (none required transfusion; p=0·0028). Haemolytic anaemia was the only serious adverse events deemed definitely or probably related to study treatment, and was reported in nine (15%) of 58 patients who received IVIG as either their first or second study treatment and none who received infliximab only. Interpretation Infliximab is a safe, well tolerated, and effective treatment for patients with IVIG resistant Kawasaki disease, and results in shorter duration of fever, reduced need for additional therapy, less severe anaemia, and shorter hospitalisation compared with second IVIG infusion.
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    Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
    (Public Library of Science, 2023-06-23) Gross, Rachel; Thaweethai, Tanayott; Rosenzweig, Erika B.; Chan, James; Chibnik, Lori B.; Cicek, Mine S.; Elliott, Amy J.; Flaherman, Valerie J.; Foulkes, Andrea S.; Witvliet, Margot Gage; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L.; Karlson, Elizabeth W.; Katz, Stuart D.; Kinser, Patricia A.; Kleinman, Lawrence C.; Lamendola-Essel, Michelle F.; Milner, Joshua D.; Mohandas, Sindhu; Mudumbi, Praveen C.; Newburger, Jane W.; Rhee, Kyung E.; Salisbury, Amy L.; Snowden, Jessica N.; Stein, Cheryl R.; Stockwell, Melissa S.; Tantisira, Kelan G.; Thomason, Moriah E.; Truong, Dongngan T.; Warburton, David; Wood, John C.; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N.; Anderson, Brett R.; Aschner, Judy L.; Atz, Andrew M.; Aupperle, Robin L.; Baker, Fiona C.; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M.; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C.; Bogie, Amanda L.; Buchbinder, Natalie C.; Bueler, Elliott; Bükülmez, Hülya; Casey, B. J.; Chang, Linda; Clark, Duncan B.; Clifton, Rebecca G.; Clouser, Katharine N.; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dummer, Kirsten B.; Elias, Matthew D.; Esquenazi-Karonika, Shari; Evans, Danielle N.; Faustino, E. Vincent S.; Fiks, Alexander G.; Forsha, Daniel; Foxe, John J.; Friedman, Naomi P.; Fry, Greta; Gaur, Sunanda; Gee, Dylan G.; Gray, Kevin M.; Harahsheh, Ashraf S.; Heath, Andrew C.; Heitzeg, Mary M.; Hester, Christina M.; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K. F.; Horowitz, Carol R.; Hsia, Daniel S.; Huentelman, Matthew; Hummel, Kathy D.; Iacono, William G.; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L.; Jone, Pei-Ni; Kaelber, David C.; Kasmarcak, Tyler J.; Kluko, Matthew J.; Kosut, Jessica S.; Laird, Angela R.; Landeo-Gutierrez, Jeremy; Lang, Sean M.; Larson, Christine L.; Lim, Peter Paul C.; Lisdahl, Krista M.; McCrindle, Brian W.; McCulloh, Russell J.; Mendelsohn, Alan L.; Metz, Torri D.; Morgan, Lerraughn M.; Müller-Oehring, Eva M.; Nahin, Erica R.; Neale, Michael C.; Ness-Cochinwala, Manette; Nolan, Sheila M.; Oliveira, Carlos R.; Oster, Matthew E.; Payne, R. Mark; Raissy, Hengameh; Randall, Isabelle G.; Rao, Suchitra; Reeder, Harrison T.; Rosas, Johana M.; Russell, Mark W.; Sabati, Arash A.; Sanil, Yamuna; Sato, Alice I.; Schechter, Michael S.; Selvarangan, Rangaraj; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M.; Stevenson, Michelle D.; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M.; Teufel, Ronald J., II; Thacker, Deepika; Udosen, Mmekom M.; Warner, Megan R.; Watson, Sara E.; Werzberger, Alan; Weyer, Jordan C.; Wood, Marion J.; Yin, H. Shonna; Zempsky, William T.; Zimmerman, Emily; Dreyer, Benard P.; Pediatrics, School of Medicine
    Importance: SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. Methods: RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. Discussion: RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.