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Communique

Communique # 47

01 July, 2021

WEEK IN REVIEW

Updates to the Living Treatment Guideline

New recommendations

Three new recommendations for the use of Casirivimab plus imdevimab (REGEN-COV)
The Disease-Modifying Treatment and Chemoprophylaxis Panel and the Guidelines Leadership Group have incorporated the recent trial results from the RECOVERY Trial publication evaluating REGEN-COV (published 16 June) into the body of evidence for casivirimab plus imdevimab and made the following three recommendations:

Conditional recommendation
Consider using casirivimab plus imdevimab in seronegative patients hospitalised with moderate to critical COVID-19.
 
Not recommended
Do not use casirivimab plus imdevimab in seropositive hospitalised patients with moderate to critical COVID-19.

Evidence for the above recommendations comes from one randomised trial (RECOVERY) that compared casirivimab plus imdevimab with standard care in 9785 patients hospitalised with moderate to critical COVID-19, a third of whom were seronegative at baseline.

Only in research settings
Do not use casirivimab plus imdevimab in mild or asymptomatic outpatients with COVID-19 outside of randomised trials with appropriate ethical approval.

Evidence comes from three randomised trials that compared casirivimab plus imdevimab with placebo in 4856 adult outpatients with mild COVID-19 and 207 asymptomatic outpatients. Two trials are linked—one presents results from the phase I-II portion and the second from the phase III portion of the study. The third study included asymptomatic patients who had close contacts with confirmed COVID-19 individuals.

The Taskforce notes that as at 24 June 2021, REGEN-COV (casirivimab plus imdevimab) is not listed in the Australian Register of Therapeutic Goods and is not approved for use in Australia.

Do Not Use recommendation for Aspirin
Following the publication of the recent RECOVERY Trial for aspirin the Taskforce has determined that aspirin probably has no impact on mortality or invasive mechanical ventilation.

Evidence indicates that aspirin is no more effective than standard care in treating patients with COVID-19 and as a result the Taskforce recommends it should not be used in the treatment of COVID-19.

Six new ‘only in research’ recommendations

  • Sotrovimab
  • Tofacitinib
  • Baricitinib for pregnant or breastfeeding women
  • Sarilumab for pregnant or breastfeeding women
  • Baricitinib for children or adolescents
  • Sarilumab for children or adolescents

Updated recommendations

  • Human umbilical cord mesenchymal stem cells—updated evidence no change to recommendation
  • Ivermectin—updated evidence no change to recommendation
  • VTE prophylaxis

Further details about these recommendations and additional updates are below.

New-look menu for Disease-Modifying Treatments 
Based on the Australian Medicines Handbook and with advice from Taskforce pharmacological experts, the menu structure for the list of Disease-Modifying Treatments has been revised to reflect the different categories of treatment.

Consumer Panel completes guidelines review
Earlier this year the Taskforce reconstituted the Consumer Panel with consumers and carers with lived experience of COVID-19. This Panel has now reviewed the preferences and values statements for existing treatment recommendations and all 2021 recommendations. Their experiences and insights have played a key role in providing strategic consumer advice to help shape the guidelines, particularly their contributions to the Care of Post-acute COVID-19 flowchart.

The Panel has now completed their term and we greatly appreciate their considered and thoughtful collaboration over the last four months.

We thank Co-Chairs Dr Eleanor Horton and Dr Rebecca Randall for their continued leadership, together with CHF Project Officer Tammy Wolffs, and gratefully acknowledge the significant contribution of all members of the panel:

  • Lynda Condon
  • Mya Cubitt
  • Chris Lassig
  • Joanne Muller
  • Sophie Noble
  • Elle Peters-Wisniak
  • Nicholas Wood

The Consumer Panel has been co-convened with our Community Partner, the Consumers Health Forum of Australia (CHF).

 

QUICK STATISTICS

COVID-19 research pipeline

  • 67,846 studies published or registered in Cochrane COVID-19 Study Register, 2,129 added this fortnight
  • 3,129 randomised controlled trials registered (data from Covid-nma site), 39 added this fortnight
  • 4,486 systematic reviews registered in PROSPERO, 182 added this fortnight
  • 348 randomised controlled trials published (data from Covid-nma site), 17 added this fortnight

 

LIVING GUIDELINES

Australian guidelines for the clinical care of people with COVID-19: Version 41.0

NEW RECOMMENDATIONS

  • Casirivimab plus imdevimab (REGEN-COV)

Conditional recommendation
Consider using casirivimab plus imdevimab in seronegative patients hospitalised with moderate to critical COVID-19.

Not recommended
Do not use casirivimab plus imdevimab in seropositive hospitalised patients with moderate to critical COVID-19.

Only in research settings
Do not use casirivimab plus imdevimab in mild or asymptomatic outpatients with COVID-19 outside of randomised trials with appropriate ethical approval.

  • Aspirin

Do not use aspirin for the treatment of COVID-19.

  • Sotrovimab, Tofacitinib, Baricitinib for pregnant or breastfeeding women, Sarilumab for pregnant or breastfeeding women, Baricitinib for children or adolescents, Sarilumab for children or adolescents

Do not use for the treatment of COVID-19 outside of randomised trials with appropriate ethical approval.

UPDATED RECOMMENDATIONS

  • Ivermectin, Human umbilical mesenchymal stem cells

Updated evidence base with no change to the strength or direction of the recommendation.

  • VTE prophylaxis

The evidence base for VTE prophylaxis in moderate patients has been updated; the strength was changed to conditional; the recommendation text was changed; there was no change to the direction of the recommendation.Moderate patients have been added to the conditional against recommendation for increased VTE prophylaxis dosages.

The Taskforce is continually monitoring research to update recommendations as new evidence emerges.

 

Australian guidelines for SARS-CoV-2 infection prevention and control of COVID-19 in healthcare workers: Version 1.0

  • No changes to recommendations this week

 

EVIDENCE UNDER REVIEW

We are currently reviewing evidence to develop recommendations and flowcharts to guide practice in areas including:

  • Budesonide
  • Corticosteroids
  • Hydroxychloroquine plus azithromycin
  • Imatinib
  • Immunoglobulin plus methylprednisolone
  • Post-exposure hydroxychloroquine prophylaxis
  • Proxalutimide
  • Remdesivir
  • Tocilizumab
  • Care of people with Post-acute COVID-19

 

NEWS & EVENTS

Cochrane Engaging Evidence 2021
Save the date for Cochrane’s upcoming Engaging Evidence 2021 (EE21) online event. If you’re based in Australia or New Zealand and work in evidence synthesis or implementation, you’re encouraged to submit papers, posters and/or workshops to present over the course of this three-day event. EE21 offers a chance to exchange knowledge and ideas, and hear what others are up to in the worlds of evidence and research synthesis. For more information and to subscribe to be notified when registration and abstract submissions open in early July, click here.

NEW TOPICS & QUESTIONS

It is a core mission of the Taskforce to engage with frontline clinicians to rapidly identify and address priority clinical questions.

Each week we collect suggestions for new clinical questions or topics for consideration by the Taskforce. A document that lists all of the suggested questions, topics and new patient groups that we have received to date is available here.

Please encourage your clinical colleagues to provide their insights via the website.

Topics