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Combination therapies for COVID-19: An overview of the clinical trials landscape

Sola Akinbolade1, Diarmuid Coughlan1, Ross Fairbairn1

  • 1National Institute for Health Research (NIHR) Innovation Observatory, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, UK.

British Journal of Clinical Pharmacology
|September 24, 2021
PubMed

Insights

This study analyzes COVID-19 combination therapy clinical trials. It focuses on dual therapies in pivotal trials, highlighting challenges and opportunities for drug development against SARS-CoV-2.

Area of Science:

  • * Virology and Infectious Diseases
  • * Clinical Pharmacology and Drug Development

Background:

  • * The COVID-19 pandemic spurred extensive global research into therapeutics for SARS-CoV-2.
  • * While monotherapies dominate, combination therapies are crucial for enhancing antiviral potency and overcoming resistance.
  • * Developing combination therapies presents significant clinical and regulatory complexities.

Purpose of the Study:

  • * To provide an overview of the clinical trial landscape for COVID-19 combination therapeutics.
  • * To analyze dual combination therapies in pivotal clinical trials (Phase II+, randomized, controlled).
  • * To focus on novel and repurposed drug candidates with promising efficacy and safety data.

Main Methods:

  • * Systematic weekly scanning of national and international clinical trial registries.
  • * Inclusion criteria focused on pivotal trials for dual combination therapies.
  • * Analysis of therapeutic candidates with positive efficacy/safety signals or emergency use authorization.

Main Results:

  • * A substantial number of COVID-19 therapeutics are in global clinical trials (744 therapeutics, 2879 trials).
  • * Monotherapies constitute nearly 90% of current COVID-19 clinical trials.
  • * The study specifically examines dual combination therapies within pivotal trials.

Conclusions:

  • * Combination therapies are essential for effective COVID-19 treatment, despite development challenges.
  • * Understanding SARS-CoV-2 lifecycle and pathology supports rationale for combination strategies.
  • * Further investigation into dual combination therapies is warranted for COVID-19 drug development.
Keywords:
COVID-19SARS-CoV-2clinical trialscombination therapypivotal trialstreatment

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