EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza

• Date:
  Thursday, 05 June 2025 , 13:00 - 17:00 Amsterdam time (CEST)
  Friday, 06 June 2025 , 13:00 - 17:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The workshop is organised to bring together academic, regulatory, industry and healthcare professionals.

It discusses similarities and major challenges experienced with the clinical study design in antiviral treatment trials for COVID-19 and influenza.

It also identifies and discusses feasible and clinically relevant primary efficacy endpoints that can generate robust data to allow the approval of new antivirals or monoclonal antibodies for the treatment of COVID-19 and influenza.

In addition, the workshop sheds light on different aspects on pandemic preparedness. These include:

• clinical study designs,
• the importance of pre-approved protocol for clinical trials that can be implemented during a pandemic,
• evidence needed to support public health recommendations and stockpiling of antivirals and monoclonal antibodies.

Documents

Agenda - EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended to treat COVID-19 and Influenza

Adopted

Presentations

Presentation - Similarities and differences between SARS-CoV-2 and Influenza (L. Derde, UMC Utrecht)

Presentation - Regulatory perspective on clinically relevant endpoints for COVID-19 and Influenza (S. Buchholz, EMA)

Presentation - Clinically relevant endpoints for COVID-19 and influenza:a clinician perspective (L.Peto, University of Oxford)

Presentation - Clinically Relevant Endpoints for Covid-19 and Influenza (R.Chandra, Novartis)

Presentation - Respiratory virus endpoints (S.Portsmouth, Shionogi)

Presentation - What are clinically relevant study endpoints for COVID-19 and Influenza? Considerations for the immunocompromised host (M.Boeckh, Fred Hutchinson Cancer Center)

Presentation - Antiviral development landscape for COVID-19 & Influenza (Intrepid Alliance)

Presentation - Efficacy of influenza antivirals in prophylaxis (University of Michigan)

Presentation - Antivirals for pre- or post-exposure prophylaxis (C.Wolfe, Duke Medicine)

Presentation - Clinical evidence for viral load as surrogate endpoint for antivirals for COVID-19 (F.Hayden, University of Virginia)

Presentation - Clinical evidence for viral load as surrogate endpoint for antivirals for COVID-19 (M.Hughes, Harvard)

Presentation - Challenges in evidence generation for COVID-19 mAbs: A regulatory experience (F.Josephson, Swedish Medical Products Agency)

Presentation - Challenges in evidence generation for COVID-19 mAbs: A clinician experience (P.Horby, University of Oxford)

Presentation - Challenges in evidence generation for COVID-19 mAbs: Industry experience (Leyden Labs)

Presentation - Challenges in evidence generation for COVID-19 mAbs: Industry experience (AstraZeneca)

Presentation - Convalescent plasma for treatment of respiratory viruses (D.Focosi, Pisa University Hospital)

Presentation - Pandemic Preparedness Session: Importance of pre-approved protocols (I.Olsen, Oslo University Hospital)

Presentation - Pandemic preparedness: Potential clinical study designs for clinical trials intended to be conducted in case of an outbreak (Y.Yazdanpanah, Paris Cite University / I.Olsen, Oslo University Hospital)

Presentation - Challenges associated with the (pre-)approval of clinical study protocols: Regulatory perspective (famhp)

Presentation - Challenges associated with the (pre-)approval of clinical study protocols: Clinician perspective (K.Lacombe, Sorbonne University)famhp)

Presentation - Remdesivir: The search for an effective treatment for COVID-19 (Y.Murata, Gilead Sciences)

Video recordings

The recordings and slides for the presentations given during the workshop are available below.

Day 1

Day 2