Ad-hoc COVID-19 Clinical Pharmacology Task Group: Statement on remdesivir

Clinical Pharmacology Task Group (CPTG) meeting date: June 12, 2020

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Policy question

The Public Health Agency of Canada (PHAC) asked the ad-hoc COVID-19 Clinical Pharmacology Task Group (CPTG) for advice on whether known and potential benefits of remdesivir outweigh known and potential risks in the treatment of patients hospitalized with COVID-19.

Recommendations

The CPTG recommends that remdesivir should only be administered as part of a randomized controlled trial to monitor whether potential benefits of remdesivir outweigh known and potential risks in the treatment of patients hospitalized with COVID-19.

The group will review emerging evidence as provided by PHAC on an ongoing basis in order to make evidence-informed recommendations in a timely manner.

This statement was approved by the Clinical Pharmacology Task Group on June 29, 2020.

Background

As of June 17, 2020, 24 clinical trials were registered worldwide to investigate remdesivir as a treatment for COVID-19, with 2 trials in Canada. These include CATCO (Canadian Treatments for COVID-19), the Canadian-led arm of WHO’s multinational Solidarity treatment trial (Sunnybrook Research Institute) and a Gilead-led expanded access open-label trial. A series of developments have brought into question the benefit-risk of remdesivir.

On June 12, 2020, the ad-hoc COVID-19 CPTG met, and part of the discussions included a benefit-risk profile of Remdesivir to be included in the pandemic response.  The Task Group discussed recent global changes in evidence and clinical practice and were provided an evidence summary prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH)Footnote 1.

Clinical evidence of efficacy to date

Clinical evidence of safety to date

Post hoc statement on authorization/licensure status worldwide (last updated 5 October 2020)

Considerations

Acknowledgments

This statement was prepared by: N Forbes, M Patel, M Rieder, and M Salvadori, on behalf of the Clinical Pharmacology Task Group (CPTG).

CPTG Members:  M Salvadori (Co-Chair), M Rieder (Co-chair),M Lordkipanidze, R Hall, M Piquette-Miller, A Collier and S Murthy.

CPTG gratefully acknowledges the contribution of:  N Abraham, A House, M Tunis, A Killikelly, Y Chung, J Courtemanche, A Coady, B Mitchelmore, E Chong, and R Goddard.

CPTG also gratefully acknowledges the contribution from the Canadian Agency for Drugs and Technologies in Health.

Footnotes

Footnote 1

CADTH, Remdesivir: Evidence Review and Appraisal. 2020: Ottawa.

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Footnote 2

Wang, Y., et al., Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet, 2020. 395(10236): p. 1569-1578.

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Footnote 3

Beigel, J.H., et al., Remdesivir for the Treatment of Covid-19 - Preliminary Report. N Engl J Med, 2020.

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Footnote 4

Goldman, J.D., et al., Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med, 2020.

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Footnote 5

Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19. 2020, www.businesswire.com

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Footnote 6

FDA, FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF REMDESIVIR (GS-5734™), FDA, Editor. 2020.

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