Search Results - "Javan, Arzhang Cyrus"

Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19 by Chew, Kara W., Moser, Carlee, Daar, Eric S., Wohl, David A., Li, Jonathan Z., Coombs, Robert W., Ritz, Justin, Giganti, Mark, Javan, Arzhang Cyrus, Li, Yijia, Choudhary, Manish C., Deo, Rinki, Malvestutto, Carlos, Klekotka, Paul, Price, Karen, Nirula, Ajay, Fischer, William, Bala, Veenu, Ribeiro, Ruy M., Perelson, Alan S., Fletcher, Courtney V., Eron, Joseph J., Currier, Judith S., Hughes, Michael D., Smith, Davey M.

“…Anti-SARS-CoV-2 monoclonal antibodies are mainstay COVID-19 therapeutics. Safety, antiviral, and clinical efficacy of bamlanivimab were evaluated in the…”
Get full text

Publisher Correction: Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19 by Chew, Kara W., Moser, Carlee, Daar, Eric S., Wohl, David A., Li, Jonathan Z., Coombs, Robert W., Ritz, Justin, Giganti, Mark, Javan, Arzhang Cyrus, Li, Yijia, Choudhary, Manish C., Deo, Rinki, Malvestutto, Carlos, Klekotka, Paul, Price, Karen, Nirula, Ajay, Fischer, William, Bala, Veenu, Ribeiro, Ruy M., Perelson, Alan S., Fletcher, Courtney V., Eron, Joseph J., Currier, Judith S., Hughes, Michael D., Smith, Davey M.

Get full text

Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial by Choudhary, Manish C., Chew, Kara W., Deo, Rinki, Flynn, James P., Regan, James, Crain, Charles R., Moser, Carlee, Hughes, Michael D., Ritz, Justin, Ribeiro, Ruy M., Ke, Ruian, Dragavon, Joan A., Javan, Arzhang Cyrus, Nirula, Ajay, Klekotka, Paul, Greninger, Alexander L., Fletcher, Courtney V., Daar, Eric S., Wohl, David A., Eron, Joseph J., Currier, Judith S., Parikh, Urvi M., Sieg, Scott F., Perelson, Alan S., Coombs, Robert W., Smith, Davey M., Li, Jonathan Z.

“…SARS-CoV-2 mutations that cause resistance to monoclonal antibody (mAb) therapy have been reported. However, it remains unclear whether in vivo emergence of…”
Get full text

ACTIV trials: cross-trial lessons learned for master protocol implementation by Keshtkar-Jahromi, Maryam, Adam, Stacey J., Brar, Indira, Chung, Lucy K., Currier, Judith S., Daar, Eric S., Davey, Victoria J., Denning, Eileen T., Gelijns, Annetine C., Higgs, Elizabeth S., Jagannathan, Prasanna, Javan, Arzhang Cyrus, Jensen, Tomas O., Jilg, Nikolaus, Kalomenidis, Ioannis, Kim, Peter, Nayak, Seema U., Newell, Matthew, Taiwo, Babafemi O., Yokum, Tammy, Delph, Yvette

“…Abstract The United States Government (USG) public-private partnership “Accelerating COVID-19 Treatment Interventions and Vaccines” (ACTIV) was launched to…”
Get full text

ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients by Currier, Judith S, Moser, Carlee, Eron, Joseph J, Chew, Kara W, Smith, Davey M, Javan, Arzhang Cyrus, Wohl, David Alain, Daar, Eric S, Hughes, Michael D

“…Abstract Clinical Trials Registration ClinicalTrials.gov Identifier: NCT04518410…”
Get full text

Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS‐CoV‐2 Infection by Bender Ignacio, Rachel A., Wohl, David A., Arends, Rosalin, Pilla Reddy, Venkatesh, Mu, Ying, Javan, Arzhang Cyrus, Hughes, Michael D., Eron, Joseph J., Currier, Judith S., Smith, Davey, Chew, Kara W., Gibbs, Michael, Fletcher, Courtney V.

“…AZD7442 (Evusheld) is a combination of two human anti‐severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) monoclonal antibodies (mAbs), tixagevimab…”
Get full text

Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial by Chew, Kara W, Moser, Carlee, Yeh, Eunice, Wohl, David A, Daar, Eric S, Ritz, Justin, Javan, Arzhang Cyrus, Eron, Joseph J, Currier, Judith S, Smith, Davey M, Hughes, Michael D

“…Abstract Background Time to symptom resolution measures were used in outpatient coronavirus disease 2019 (COVID-19) treatment trials without prior validation…”
Get full text

Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19 by Evering, Teresa H, Chew, Kara W, Giganti, Mark J, Moser, Carlee, Pinilla, Mauricio, Wohl, David Alain, Currier, Judith S, Eron, Joseph J, Javan, Arzhang Cyrus, Bender Ignacio, Rachel, Margolis, David, Zhu, Qing, Ma, Ji, Zhong, Lijie, Yan, Li, D'Andrea Nores, Ulises, Hoover, Keila, Mocherla, Bharat, Choudhary, Manish C, Deo, Rinki, Ritz, Justin, Fischer, William A, Fletcher, Courtney V, Li, Jonathan Z, Hughes, Michael D, Smith, Davey, Daar, Eric S

“…Development of safe and effective SARS-CoV-2 therapeutics is a high priority. Amubarvimab and romlusevimab are noncompeting anti-SARS-CoV-2 monoclonal…”
Get full text

Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection by Deo, Rinki, Choudhary, Manish C, Moser, Carlee, Ritz, Justin, Daar, Eric S, Wohl, David A, Greninger, Alexander L, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M, Chew, Kara W, Li, Jonathan Z

“…Although symptom and viral rebound have been reported after nirmatrelvir-ritonavir treatment, the trajectories of symptoms and viral load during the natural…”
Get full text

Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial by Moser, Carlee B, Chew, Kara W, Ritz, Justin, Newell, Matthew, Javan, Arzhang Cyrus, Eron, Joseph J, Daar, Eric S, Wohl, David A, Currier, Judith S, Smith, Davey M, Hughes, Michael D

“…Abstract Adaptive platform trials were implemented during the coronavirus disease 2019 (COVID-19) pandemic to rapidly evaluate therapeutics, including the…”
Get full text

Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019 by Li, Yijia, Harrison, Linda J, Chew, Kara W, Currier, Judy S, Wohl, David A, Daar, Eric S, Evering, Teresa H, Wu, Ryan, Giganti, Mark, Ritz, Justin, Javan, Arzhang Cyrus, Coombs, Robert W, Moser, Carlee, Hughes, Michael D, Eron, Joseph J, Smith, Davey M, Li, Jonathan Z

“…Acute Coronavirus Disease 2019 symptoms limit daily activities, but little is known about its association with severe acute respiratory syndrome coronavirus 2…”
Get full text

Viral and symptom rebound following anti-SARS-CoV-2 monoclonal antibody therapy in a randomized placebo-controlled trial by Chew, Kara W, McGinley, Brooke, Moser, Carlee, Li, Jonathan Z, Evering, Teresa H, Ritz, Justin, Javan, Arzhang Cyrus, Margolis, David, Wohl, David A, Hughes, Michael D, Daar, Eric S, Currier, Judith S, Eron, Joseph J, Smith, Davey M

“…We explored viral and symptom rebound after COVID-19 amubarvimab/romlusevimab monoclonal antibody therapy vs placebo in the randomized ACTIV-2/A5401 trial…”
Get full text

Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials by Moser, Carlee B, Chew, Kara W, Giganti, Mark J, Li, Jonathan Z, Aga, Evgenia, Ritz, Justin, Greninger, Alexander L, Javan, Arzhang Cyrus, Bender Ignacio, Rachel, Daar, Eric S, Wohl, David A, Currier, Judith S, Eron, Joseph J, Smith, Davey M, Hughes, Michael D

“…Abstract Most clinical trials evaluating coronavirus disease 2019 (COVID-19) therapeutics include assessments of antiviral activity. In recently completed…”
Get full text

Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial by Chew, Kara W, Taiwo, Babafemi O, Moser, Carlee, Daar, Eric S, Wohl, David Alain, Ritz, Justin, Javan, Arzhang Cyrus, Li, Jonathan Z, Fischer, William, Greninger, Alexander L, Bausch, Christoph, Luke, Thomas, Call, Robert, Neytman, Gene, Giganti, Mark J, Fletcher, Courtney V, Hughes, Michael D, Eron, Joseph J, Currier, Judith S, Smith, Davey M, Chew, Kara, Smith, David (Davey), Daar, Eric, Wohl, David, Currier, Judith, Eron, Joseph, Javan, Arzhang Cyrus, Hughes, Michael, Moser, Carlee, Giganti, Mark, Ritz, Justin, Hosey, Lara, Roa, Jhoanna, Patel, Nilam, Colsh, Kelly, Rwakazina, Irene, Beck, Justine, Sieg, Scott, Li, Jonathan, Fletcher, Courtney, Fischer, William, Evering, Teresa, Ignacio, Rachel Bender, Cardoso, Sandra, Corado, Katya, Jagannathan, Prasanna, Jilg, Nikolaus, Perelson, Alan, Pillay, Sandy, Riviere, Cynthia, Singh, Upinder, Taiwo, Babafemi, Gottesman, Joan, Newell, Matthew, Pedersen, Susan, Dragavon, Joan, Jennings, Cheryl, Greenfelder, Brian, Murtaugh, William, Kosmyna, Jan, Gapara, Morgan, Shahkolahi, Akbar

“…Abstract Background We evaluated the fully human polyclonal antibody product SAB-185 in a phase 3 trial for COVID-19. Methods Nonhospitalized high-risk adults…”
Get full text

One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial by Jilg, Nikolaus, Chew, Kara W, Giganti, Mark J, Daar, Eric S, Wohl, David A, Javan, Arzhang Cyrus, Kantor, Amy, Moser, Carlee, Coombs, Robert W, Neytman, Gene, Hoover, Keila, Jana, Atasi, Hart, Phil A, Greninger, Alexander L, Szurgot, Bob, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M, Li, Jonathan Z

“…Abstract Background Camostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of…”
Get full text

Long COVID After Bamlanivimab Treatment by Evering, Teresa H, Moser, Carlee B, Jilg, Nikolaus, Yeh, Eunice, Sanusi, Busola, Wohl, David A, Daar, Eric S, Li, Jonathan Z, Klekotka, Paul, Javan, Arzhang Cyrus, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M, Chew, Kara W

“…Abstract Background Prospective evaluations of long COVID in outpatients with coronavirus disease 2019 (COVID-19) are lacking. We aimed to determine the…”
Get full text

Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19 by Taiwo, Babafemi O, Chew, Kara W, Moser, Carlee, Wohl, David Alain, Daar, Eric S, Li, Jonathan Z, Greninger, Alexander L, Bausch, Christoph, Luke, Thomas, Hoover, Keila, Neytman, Gene, Giganti, Mark J, Olefsky, Maxine, Javan, Arzhang Cyrus, Fletcher, Courtney V, Eron, Joseph J, Currier, Judith S, Hughes, Michael D, Smith, Davey M

“…In this phase 2 evaluation of SAB-185 in the ACTIV-2/ACTG A5401 platform trial of investigational agents for outpatient COVID-19 treatment, this…”
Get full text

Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19 by Giganti, Mark J, Chew, Kara W, Eron, Joseph J, Li, Jonathan Z, Pinilla, Mauricio, Moser, Carlee, Javan, Arzhang Cyrus, Fischer, William A, Klekotka, Paul, Margolis, David, Wohl, David Alain, Coombs, Robert W, Daar, Eric S, Smith, Davey M, Currier, Judith S, Hughes, Michael D

“…Abstract Background There is little information regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA as a predictor for clinical outcomes…”
Get full text

Safety and Efficacy of SAB-185 for Non-hospitalized Adults with COVID-19: A Randomized Clinical Trial by Chew, Kara W, Taiwo, Babafemi O, Moser, Carlee, Daar, Eric S, Wohl, David Alain, Ritz, Justin, Javan, Arzhang Cyrus, Li, Jonathan Z, Fischer, William, Greninger, Alexander L, Bausch, Christoph, Luke, Thomas, Call, Robert, Neytman, Gene, Giganti, Mark J, Fletcher, Courtney V, Hughes, Michael D, Eron, Joseph J, Currier, Judith S, Smith, Davey M

“…To address the need for novel COVID-19 therapies, we evaluated the fully-human polyclonal antibody product SAB-185 in a phase 3 clinical trial…”
Get full text

881. Nasal and Plasma SARS-CoV-2 RNA Levels Predict Timing of Symptom Resolution in the ACTIV-2 Trial of Non-hospitalized Adults with COVID-19 by Li, Yijia, Harrison, Linda J, Chew, Kara W, Eron, Joseph J, Daar, Eric S, Wohl, David A, Wu, Ryan, Moser, Carlee, Ritz, Justin, Giganti, Mark, Javan, Arzhang Cyrus, Coombs, Robert, Hughes, Michael D, Currier, Judith S, Smith, Davey M, Li, Jonathan Z

“…Abstract Background Symptoms during acute COVID-19 can limit daily activities and delay return to work and school. Little is known about the association…”
Get full text