Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trialResearch in context

Autor: Prasanna Jagannathan, Kara W. Chew, Mark J. Giganti, Michael D. Hughes, Carlee Moser, Mark J. Main, Phillip D. Monk, Arzhang Cyrus Javan, Jonathan Z. Li, Courtney V. Fletcher, Caitlyn McCarthy, David A. Wohl, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Upinder Singh, Davey M. Smith, William Fischer, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Justin Ritz, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, Teresa Evering, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Nikolaus Jilg, Alan Perelson, Sandy Pillay, Cynthia Riviere, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Gerald Pierone, Juliana Elliott, Jeffrey Jacobson, Leila Hojat, Julie Pasternak, Jonathan Berardi, Celine Arar, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Sadia Shaik, Timothy Hatlen, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Keila Hoover, James Renfroe, Mauney Weldon, Genei Bougher, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Gene Neytman, Jack Herman, Craig Herman, Mariam Aziz, Joan Swiatek, Divya Pathak, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Aleen Khodabakhshian, Samantha Fortier, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Sarah McGuffin, Chris Jonsson, Rachel Presti, Alem Haile

Publikováno v: EClinicalMedicine, Vol 65, Iss , Pp 102250- (2023)

Summary: Background: With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical nee

Externí odkaz: https://doaj.org/article/454735c4a8b341a688fdabe4d9bc0450

The impact of data quality and source data verification on epidemiologic inference: a practical application using HIV observational data

Autor: Mark J. Giganti, Bryan E. Shepherd, Yanink Caro-Vega, Paula M. Luz, Peter F. Rebeiro, Marcelle Maia, Gaetane Julmiste, Claudia Cortes, Catherine C. McGowan, Stephany N. Duda

Publikováno v: BMC Public Health, Vol 19, Iss 1, Pp 1-11 (2019)

Abstract Background Data audits are often evaluated soon after completion, even though the identification of systematic issues may lead to additional data quality improvements in the future. In this study, we assess the impact of the entire data audi

Externí odkaz: https://doaj.org/article/cc8654dce9eb46f5b3add1f9e5ef752b

Statistical Challenges when Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials

Autor: Carlee B Moser, Kara W Chew, Mark J Giganti, Jonathan Z. Li, Evgenia Aga, Justin Ritz, Alex Greninger, Arzhang Cyrus Javan, Rachel A Bender Ignacio, Eric S Daar, David A Wohl, Judith S Currier, Joseph J Eron, Davey M Smith, Michael D Hughes

Publikováno v: medRxiv

Most clinical trials evaluating COVID-19 therapeutics include assessments of antiviral activity. In recently completed outpatient trials, changes in nasal SARS-CoV-2 RNA levels from baseline were commonly assessed using analysis of covariance (ANCOVA

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::444c597a5db7472b83d816f388ab8361
https://europepmc.org/articles/PMC10055451/

Plasma biomarker factors associated with neurodevelopmental outcomes in children with perinatal HIV infection and controlled viremia

Autor: Michael J. Boivin, Jennifer Canniff, Mark J. Giganti, Patricia A. Sirois, Mark J. Abzug, Suad Kapetanovic, Allison L. Agwu, Jane C. Lindsey, Adriana Weinberg, Grace Montepiedra

Publikováno v: AIDS

OBJECTIVE We examined relationships between plasma biomarkers and neurodevelopment in children from sub-Saharan Africa with perinatal HIV (PHIV) with controlled viremia on antiretroviral therapy (ART). DESIGN Longitudinal retrospective cohort study o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0408b5c840409b3bbd1021e0c8494ba4
https://doi.org/10.1097/qad.0000000000002862

Multiple-Imputation Variance Estimation in Studies With Missing or Misclassified Inclusion Criteria

Autor: Bryan E. Shepherd, Mark J. Giganti

Publikováno v: Am J Epidemiol

In observational studies using routinely collected data, a variable with a high level of missingness or misclassification may determine whether an observation is included in the analysis. In settings where inclusion criteria are assessed after imputa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7cf7d239d91e9c378ac7ca951653932
https://doi.org/10.1093/aje/kwaa153