Remdesivir for COVID-19: Case Study and Clinical Trial Design

Webinar

July 16 - July 16, 2020

Webinar |

 

1:30 Chairperson’s Remarks
Anu Osinusi, MD, MPH, Executive Director, Clinical Research, Gilead Sciences

1:35 Broad Spectrum Antiviral Remdesivir for the Treatment of Emerging Viral Infections with High Outbreak Potential
Danielle Poulin Porter, PhD, Director, Clinical Virology, Gilead Sciences
Remdesivir is a nucleotide prodrug with potent in vitro and in vivo antiviral activity against multiple emerging virus families with high outbreak potential including filoviruses (e.g. Ebola and Marburg), coronaviruses (e.g. MERS-CoV, SARS-CoV, and SARS-CoV-2) and paramyxoviruses (e.g. Nipah). The preclinical profile of remdesivir supports its further development as an antiviral for COVID-19 as well as potentially other emerging viral infections with significant outbreak potential.

1:55  Optimizing study site selection for SARS-CoV-2 antiviral trials
Frances Oko, Sr. Director, Integrated Solutions, Infectious Disease / Immunology, Parexel
Through our expanding experience in the emerging COVID-19 therapeutic field, Parexel has gained insight into best strategies for optimizing site selection for COVID-19 antiviral trials. We will discuss how site identification for these studies depends on several factors including projected local disease activity, regulatory guidelines and timelines, competitive landscape, and evolving standard-of-care.

2:15 Remdesivir for COVID-19: Challenges in Trial Strategy and Design
Anu Osinusi, MD, MPH, Executive Director, Clinical Research, Gilead Sciences

2:35 Remdesivir for Treatment of COVID-19: Clinical Trials and Beyond
Jason D. Goldman, MD, MPH, Infectious Disease and Organ Transplant, Swedish Medical Center; Clinical Assistant Professor, Division of Allergy & Infectious Diseases, University of Washington
Remdesivir is the first treatment to show clinical efficacy in the treatment of patients with COVID-19. I will review the clinical trial results of remdesivir in patients with SARS-CoV-2 infection and address current gaps in knowledge. Finally, I will make recommendations about appropriate use of remdesivir in the context of the ongoing global pandemic and limited drug supply.

2:55 Closing Remarks

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