Implementation of an Online Drug–Drug Interaction Screener for the STRIVE Ensitrelvir Trial for COVID-19 - Summary - MDSpire

Implementation of an Online Drug–Drug Interaction Screener for the STRIVE Ensitrelvir Trial for COVID-19

  • By

  • Joshua P Havens

  • Nayon Kang

  • Lucy Chung

  • Courtney V Fletcher

  • Page Crew

  • Jacqueline Nordwall

  • Lianne Siegel

  • Katrina Harper

  • Birgit Grund

  • Marcelo Losso

  • Shikha Vasudeva

  • Kyle C Molina

  • Adit A Ginde

  • Ryosuke Shimizu

  • Ahmad Mourad

  • Alpha Diallo

  • Mina Pak

  • Anne Davis-Karim

  • Phiona Nabaggala

  • Alfredo J Mena Lora

  • Derek W Russell

  • Sho Saito

  • Jason V Baker

  • for the STRIVE Ensitrelvir Trial Study Group and the STRIVE Network

  • June 11, 2025

  • 0 min

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Objective:

To develop and implement an online drug-drug interaction (DDI) screener for the STRIVE trial evaluating ensitrelvir in hospitalized COVID-19 patients, addressing the complexities of managing multiple medications.

Key Findings:
  • 334 participants enrolled across 150 sites in 13 countries.
  • 117,192 screener searches completed by May 2024.
  • Antihypertensives, antibiotics, corticosteroids, and anticoagulants were the most searched medication classes, with anticoagulants and immunosuppressants posing significant challenges due to trial blinding.
  • Prohibited medications were revised to conditionally permit enrollment in 11 cases after dosage adjustments.
Interpretation:

The DDI screener proved essential for managing complex medication regimens in a clinical trial setting, particularly for drugs with high DDI potential like ensitrelvir, highlighting its importance for future clinical trials.

Limitations:
  • The DDI screener's effectiveness may vary based on site-specific practices and medication availability, potentially impacting trial outcomes.
  • Challenges in trial blinding complicated the management of anticoagulants and immunosuppressants, which may affect the overall trial integrity.
Conclusion:

The development of a DDI screener is crucial for the safe conduct of clinical trials involving investigational medications with significant DDI potential, highlighting the need for a multidisciplinary approach.

Original Source(s)

Implementation of an Online Drug–Drug Interaction Screener for the STRIVE Ensitrelvir Trial for COVID-19

  • by Joshua P Havens, Nayon Kang, Lucy Chung, Courtney V Fletcher, Page Crew, Jacqueline Nordwall, Lianne Siegel, Katrina Harper, Birgit Grund, Marcelo Losso, Shikha Vasudeva, Kyle C Molina, Adit A Ginde, Ryosuke Shimizu, Ahmad Mourad, Alpha Diallo, Mina Pak, Anne Davis-Karim, Phiona Nabaggala, Alfredo J Mena Lora, Derek W Russell, Sho Saito, Jason V Baker, for the STRIVE Ensitrelvir Trial Study Group and the STRIVE Network

  • June 11, 2025

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