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Communique

Weekly Communique # 25

01 October, 2020

WEEK IN REVIEW

List of drugs not recommended for use outside of clinical trials continues to grow

The Disease-Modifying Treatment and Chemoprophylaxis Panel has reviewed new trial results for three experimental treatments for COVID-19, concluding that there is still insufficient evidence to recommend their use outside the context of a randomised trial with appropriate ethical approval. These include:

  • Hydroxychloroquine plus azithromycin in combination
  • Recombinant human granulocyte colony-stimulating factor (rhG-CSF)
  • Tocilizumab

(Please see below for important additional information accompanying these recommendations.)

Hundreds of interventions are being evaluated to determine their effectiveness and safety in treating people with COVID-19, with more than 1800 randomised trials registered since the start of the pandemic. The Taskforce continually monitors the global literature for data from trials that evaluate any disease-modifying treatments for COVID-19. As each new trial is published, our panels assess the quality of the evidence and make recommendations on whether the treatment should be used in the clinical care of patients.

Consumer Panel considers patient preferences and values

The Taskforce Consumer Panel has reviewed the key information provided for recommendations on disease-modifying treatments that are not recommended outside of clinical trials. On the basis there is no available evidence that would suggest the certainty of these treatments to informed patients, the Panel believes that most patients would agree with the recommendations.

The Panel also reviewed the key information provided for recommendations on therapies for pre-existing conditions in patients with COVID-19, including: angiotensin converting enzyme inhibitors and angiotensin receptor blockers (ACEIs/ARBs) and steroids for people with asthma or Chronic Obstructive Pulmonary Disease (COPD).

In line with available evidence, the Panel believes that informed patients would agree with the recommendations, and wish to continue with their prescribed treatment for their pre-existing conditions

 


QUICK STATISTICS

COVID-19 research pipeline

  • 22,186 studies published or registered in Cochrane COVID-19 Study Register, 958 added this week
  • 1,836 randomised controlled trials registered (data from Covid-nma site), 32 added this week
  • 2,275 systematic reviews registered in PROSPERO, 49 added this week
  • 71 randomised controlled trials published (data from Covid-nma site), added this week

 


NEW OR UPDATED RECOMMENDATIONS

Australian guidelines for the clinical care of people with COVID-19: Version 24.0

NEW RECOMMENDATIONS

  • Hydroxychloroquine plus azithromycin

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

Hydroxychloroquine plus azithromycin should still be considered for other evidence-based indications in people who have COVID-19.

Trials are needed in special populations, including children and adolescents, pregnant and breastfeeding women, older people living with frailty and those receiving palliative care. Until further evidence is available, do not use hydroxychloroquine plus azithromycin for the treatment of COVID-19 in these populations unless they are eligible to be enrolled in trials.

  • Recombinant human granulocyte colony-stimulating factor (rhG-CSF)

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

Recombinant human granulocyte colony-stimulating factor should still be considered for other evidence-based indications in people who have COVID-19.

Trials are needed in special populations, including children and adolescents, pregnant and breastfeeding women, older people living with frailty and those receiving palliative care. Until further evidence is available, do not use rhG-CSF to treat COVID-19 in these populations unless they are eligible to be enrolled in trials.

  • Tocilizumab

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

This recommendation does not apply to the use of Tocilizumab in children and adolescents when managing paediatric inflammatory multisystem syndrome (PIMS-TS), Kawasaki disease or toxic shock syndrome related to COVID-19. The Taskforce is currently developing recommendations for the management of these conditions in children and adolescents with COVID-19.

Trials are needed in special populations, including children and adolescents, pregnant and breastfeeding women, older people living with frailty and those receiving palliative care. Until further evidence is available, do not use tocilizumab for the treatment of COVID-19 in these populations unless they are eligible to be enrolled in trials.

UPDATES TO EXISTING GUIDANCE

  • Umifenovir

The evidence base has been updated with no change to the strength or direction of the recommendation.

  • Disease-modifying treatments not recommended outside of clinical trials

The language of the recommendations and the rationales have been updated for clarity, and the key information on patient preferences and values has been
updated for all recommendations in this section with no changes to the strength or directions of the recommendations.

  • Therapies for pre-existing conditions in patients with COVID-19

The key information on patient preferences and values has been updated for all recommendations in this section with no changes to the strength or directions of the recommendations.

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

 


CLINICAL FLOWCHARTS

Seven clinical flowcharts have been developed by the Taskforce to cover:

  • Assessment for suspected COVID-19
  • Management of adults with mild COVID-19 UPDATED
  • Management of adults with moderate to severe COVID-19 UPDATED
  • Management of adults with severe to critical COVID-19 UPDATED
  • Respiratory support for adults with severe to critical COVID-19
  • Management of people with COVID-19 who are older and living with frailty and/or cognitive impairment
  • Management of people with COVID-19 who are receiving palliative care

Changes to flowcharts this week reflect:

  • Updated list of disease-modifying treatments for COVID-19 that are not recommended outside of randomised trials
  • New statement on the continued use of disease-modifying treatments for other evidence-based indications.

 


EVIDENCE UNDER REVIEW

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

  • Ivermectin NEW
  • Enoxaparin NEW
  • Hydroxychloroquine for pre-exposure chemoprophylaxis NEW
  • Interferon-kappa +  TFF2 NEW
  • N-acetylcysteine NEW
  • Care of people recovering from COVID-19/Post-viral syndrome NEW
  • Cardiac arrest
  • Paediatric Multisystem Inflammatory Syndrome (PIMS-TS)

 


NEWS & EVENTS

NPS MedicineWise

A new podcast titled ‘Managing diabetes during COVID-19’ was published this week. In this episode NPS MedicineWise CEO, Steve Morris talks to Greg Johnson, CEO of Diabetes Australia, about the biggest challenges facing people with diabetes during the COVID-19 pandemic, why diabetes is a ‘pandemic within a pandemic’, feedback from consumers about telehealth, and the importance of addressing mental health.

A new article on vaccines and COVID-19 for both health professionals and consumers which was reviewed by National Centre for Immunisation and Research is also now available.

 


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.

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