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4. Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial

Author

Anderson, Blake, Atwater, Riannon C, Avula, Nandini, Beckman, Kenny B, Belani, Hrishikesh K, Boulware, David R, Bramante, Carolyn T, Brea, Jannis, Broedlow, Courtney A, Buse, John B, Campora, Paula, Challa, Anup, Charles, Jill, Christensen, Grace, Christiansen, Theresa, Cohen, Ken, Connelly, Bo, Datta, Srijani, Deng, Nikita, Dunn, Alex T, Erickson, Spencer M, Fairbairn, Faith M, Fenno, Sarah L, Fraser, Daniel J, Fricton, Regina D, Griffiths, Gwen, Hagen, Aubrey A, Hartman, Katrina M, Hendrickson, Audrey F, Huling, Jared D, Ingraham, Nicholas E, Jeng, Arthur C, Johnson, Darrell M, Karger, Amy B, Klatt, Nichole R, Kuehl, Erik A, LaBar, Derek D, Lee, Samuel, Liebovitz, David M, Lindberg, Sarah, Luke, Darlette G, Machicado, Rosario, Mohamud, Zeinab, Murray, Thomas A, Ngonyama, Rumbidzai, Nicklas, Jacinda M, Odde, David J, Parrens, Elliott, Parra, Daniela, Patel, Barkha, Proper, Jennifer L, Pullen, Matthew F, Puskarich, Michael A, Rao, Via, Reddy, Neha V, Reddy, Naveen, Rypka, Katelyn J, Saveraid, Hanna G, Seloadji, Paula, Shahriar, Arman, Sherwood, Nancy, Siegart, Jamie L, Siegel, Lianne K, Simmons, Lucas, Sinelli, Isabella, Singh, Palak, Snyder, Andrew, Stauffer, Maxwell T, Thompson, Jennifer, Tignanelli, Christopher J, Tople, Tannon L, Tordsen, Walker J, Watson, Ray HB, Wu, Beiqing, Zaman, Adnin, Zolik, Madeline R, Zinkl, Lena, Anderson, Blake J, Thompson, Jennifer L, Pullen, Matthew, Wirtz, Esteban Lemus, Sherwood, Nancy E, Lindberg, Sarah M, Beckman, Kenneth B, Rose, Michael R, Mehta, Tanvi, Griffiths, Gwendolyn, and Bhat, Neeta S

Published
2023
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7. Directed cell migration towards softer environments

Author

Isomursu, Aleksi, Park, Keun-Young, Hou, Jay, Cheng, Bo, Mathieu, Mathilde, Shamsan, Ghaidan A., Fuller, Benjamin, Kasim, Jesse, Mahmoodi, M. Mohsen, Lu, Tian Jian, Genin, Guy M., Xu, Feng, Lin, Min, Distefano, Mark D., Ivaska, Johanna, and Odde, David J.

Published
2022
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13. Mutual antagonism between CD44 and integrins in glioblastoma cell traction and migration.

Author

Kelly, Marcus D., Pawlak, Matthew R., Zhan, Kevin H., Shamsan, Ghaidan A., Gordon, Wendy R., and Odde, David J.

Subjects
CELL migration, CD44 antigen, EXTRACELLULAR matrix, HYALURONIC acid, CANCER invasiveness
Abstract

Cell migration is the major driver of invasion and metastasis during cancer progression. For cells to migrate, they utilize the actin–myosin cytoskeleton and adhesion molecules, such as integrins and CD44, to generate traction forces in their environment. CD44 primarily binds to hyaluronic acid (HA) and integrins primarily bind to extracellular matrix (ECM) proteins such as collagen. However, the role of CD44 under integrin-mediated conditions and vice versa is not well known. Here, we performed traction force microscopy (TFM) on U251 cells seeded on collagen I-coated polyacrylamide gels to assess the functional mechanical relationship between integrins and CD44. Performing TFM on integrin-mediated adhesion conditions, i.e., collagen, we found that CD44KO U251 cells exerted more traction force than wild-type (WT) U251 cells. Furthermore, untreated WT and CD44-blocked WT exhibited comparable results. Conversely, in CD44-mediated adhesive conditions, integrin-blocked WT cells exerted a higher traction force than untreated WT cells. Our data suggest that CD44 and integrins have a mutually antagonistic relationship where one receptor represses the other's ability to generate traction force on its cognate substrate. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Favorable Antiviral Effect of Metformin on SARS-CoV-2 Viral Load in a Randomized, Placebo-Controlled Clinical Trial of COVID-19.

Author

Bramante, Carolyn T, Beckman, Kenneth B, Mehta, Tanvi, Karger, Amy B, Odde, David J, Tignanelli, Christopher J, Buse, John B, Johnson, Darrell M, Watson, Ray H B, Daniel, Jerry J, Liebovitz, David M, Nicklas, Jacinda M, Cohen, Ken, Puskarich, Michael A, Belani, Hrishikesh K, Siegel, Lianne K, Klatt, Nichole R, Anderson, Blake, Hartman, Katrina M, and Rao, Via

Subjects
MORTALITY prevention, METFORMIN, VIRAL load, EMERGENCY room visits, HOSPITAL care, FLUVOXAMINE, REVERSE transcriptase polymerase chain reaction, DESCRIPTIVE statistics, ANTIVIRAL agents, RACE, ODDS ratio, DRUG efficacy, MACROLIDE antibiotics, CONFIDENCE intervals, COVID-19
Abstract

Background Metformin has antiviral activity against RNA viruses including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The mechanism appears to be suppression of protein translation via targeting the host mechanistic target of rapamycin pathway. In the COVID-OUT randomized trial for outpatient coronavirus disease 2019 (COVID-19), metformin reduced the odds of hospitalizations/death through 28 days by 58%, of emergency department visits/hospitalizations/death through 14 days by 42%, and of long COVID through 10 months by 42%. Methods COVID-OUT was a 2 × 3 randomized, placebo-controlled, double-blind trial that assessed metformin, fluvoxamine, and ivermectin; 999 participants self-collected anterior nasal swabs on day 1 (n = 945), day 5 (n = 871), and day 10 (n = 775). Viral load was quantified using reverse-transcription quantitative polymerase chain reaction. Results The mean SARS-CoV-2 viral load was reduced 3.6-fold with metformin relative to placebo (−0.56 log10 copies/mL; 95% confidence interval [CI], −1.05 to −.06; P =.027). Those who received metformin were less likely to have a detectable viral load than placebo at day 5 or day 10 (odds ratio [OR], 0.72; 95% CI,.55 to.94). Viral rebound, defined as a higher viral load at day 10 than day 5, was less frequent with metformin (3.28%) than placebo (5.95%; OR, 0.68; 95% CI,.36 to 1.29). The metformin effect was consistent across subgroups and increased over time. Neither ivermectin nor fluvoxamine showed effect over placebo. Conclusions In this randomized, placebo-controlled trial of outpatient treatment of SARS-CoV-2, metformin significantly reduced SARS-CoV-2 viral load, which may explain the clinical benefits in this trial. Metformin is pleiotropic with other actions that are relevant to COVID-19 pathophysiology. Clinical Trials Registration NCT04510194. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Myosin IIA suppresses glioblastoma development in a mechanically sensitive manner

Author

Picariello, Hannah S., Kenchappa, Rajappa S., Rai, Vandana, Crish, James F., Dovas, Athanassios, Pogoda, Katarzyna, McMahon, Mariah, Bell, Emily S., Chandrasekharan, Unnikrishnan, Luu, Amanda, West, Rita, Lammerding, Jan, Canoll, Peter, Odde, David J., Janmey, Paul A., Egelhoff, Thomas, and Rosenfeld, Steven S.

Published
2019

26. The OTX2 Gene Induces Tumor Growth and Triggers Leptomeningeal Metastasis by Regulating the mTORC2 Signaling Pathway in Group 3 Medulloblastomas.

Author

Ampudia-Mesias, Elisabet, Cameron, Charles S., Yoo, Eunjae, Kelly, Marcus, Anderson, Sarah M., Manning, Riley, Abrahante Lloréns, Juan E., Moertel, Christopher L., Yim, Hyungshin, Odde, David J., Saydam, Nurten, and Saydam, Okay

Subjects
CELLULAR signal transduction, TUMOR growth, METASTASIS, GENE expression, CELL motility, TUMOR suppressor genes, HOMEOBOX genes
Abstract

Medulloblastoma (MB) encompasses diverse subgroups, and leptomeningeal disease/metastasis (LMD) plays a substantial role in associated fatalities. Despite extensive exploration of canonical genes in MB, the molecular mechanisms underlying LMD and the involvement of the orthodenticle homeobox 2 (OTX2) gene, a key driver in aggressive MB Group 3, remain insufficiently understood. Recognizing OTX2's pivotal role, we investigated its potential as a catalyst for aggressive cellular behaviors, including migration, invasion, and metastasis. OTX2 overexpression heightened cell growth, motility, and polarization in Group 3 MB cells. Orthotopic implantation of OTX2-overexpressing cells in mice led to reduced median survival, accompanied by the development of spinal cord and brain metastases. Mechanistically, OTX2 acted as a transcriptional activator of the Mechanistic Target of Rapamycin (mTOR) gene's promoter and the mTORC2 signaling pathway, correlating with upregulated downstream genes that orchestrate cell motility and migration. Knockdown of mTOR mRNA mitigated OTX2-mediated enhancements in cell motility and polarization. Analysis of human MB tumor samples (N = 952) revealed a positive correlation between OTX2 and mTOR mRNA expression, emphasizing the clinical significance of OTX2's role in the mTORC2 pathway. Our results reveal that OTX2 governs the mTORC2 signaling pathway, instigating LMD in Group 3 MBs and offering insights into potential therapeutic avenues through mTORC2 inhibition. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination and Booster on Coronavirus Disease 2019 (COVID-19) Symptom Severity Over Time in the COVID-OUT Trial.

Author

Boulware, David R, Murray, Thomas A, Proper, Jennifer L, Tignanelli, Christopher J, Buse, John B, Liebovitz, David M, Nicklas, Jacinda M, Cohen, Kenneth, Puskarich, Michael A, Belani, Hrishikesh K, Siegel, Lianne K, Klatt, Nichole R, Odde, David J, Karger, Amy B, Ingraham, Nicholas E, Hartman, Katrina M, Rao, Via, Hagen, Aubrey A, Patel, Barkha, and Fenno, Sarah L

Subjects
IMMUNIZATION, COVID-19, COVID-19 vaccines, SEVERITY of illness index, SECONDARY analysis
Abstract

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has decreasing protection from acquiring any infection with emergence of new variants; however, vaccination continues to protect against progression to severe coronavirus disease 2019 (COVID-19). The impact of vaccination status on symptoms over time is less clear. Methods Within a randomized trial on early outpatient COVID-19 therapy testing metformin, ivermectin, and/or fluvoxamine, participants recorded symptoms daily for 14 days. Participants were given a paper symptom diary allowing them to circle the severity of 14 symptoms as none (0), mild (1), moderate (2), or severe (3). This is a secondary analysis of clinical trial data on symptom severity over time using generalized estimating equations comparing those unvaccinated, SARS-CoV-2 vaccinated with primary vaccine series only, or vaccine-boosted. Results The parent clinical trial prospectively enrolled 1323 participants, of whom 1062 (80%) prospectively recorded some daily symptom data. Of these, 480 (45%) were unvaccinated, 530 (50%) were vaccinated with primary series only, and 52 (5%) vaccine-boosted. Overall symptom severity was least for the vaccine-boosted group and most severe for unvaccinated at baseline and over the 14 days (P <.001). Individual symptoms were least severe in the vaccine-boosted group including cough, chills, fever, nausea, fatigue, myalgia, headache, and diarrhea, as well as smell and taste abnormalities. Results were consistent over Delta and Omicron variant time periods. Conclusions SARS-CoV-2 vaccine-boosted participants had the least severe symptoms during COVID-19, which abated the quickest over time. Clinical Trial Registration. NCT04510194. [ABSTRACT FROM AUTHOR]

Published
2023
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