Update 31 August 2021

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Background

This guidance applies only to patients with COVID-19 who are managed as an inpatient in a physical hospital. It includes evidence-based recommendations, as well as guidance and resources supporting therapeutic decision-making, drug access, governance and utilisation in hospital.  

As evidence emerges from clinical trials, recommendations regarding the use of some disease-modifying medicines in COVID-19 can now be made, while the use of other disease-modifying medicines remains best limited to a clinical trial setting. Recommendations can also be made where the use of some medicines should not occur. The Australian guidelines for the clinical care of people with COVID-19 is the nationally recognised source for specific, patient-focused recommendations on management and care of people with suspected or confirmed COVID-19. 

The tables below summarise the recommendations regarding specific disease-modifying medicines, as of  August 31, 2021, with guidance on access, governance and resources to support use in hospital. Additional Summary Guidances for Pharmacological Management of Hospitalised Patients with COVID-19- adults, pregnant and breastfeeding women and children and adolescents- can be found on the NSW Therapeutic Advisory Group website - see Medicines use in the treatment of COVID-19. A verbal consent form/guide for one or more COVID-specific medicines (remdesivir, baricitinib, tocilizumab) can be found at Medicines use in the treatment of COVID-19

​Immunomodulatory agents

Specific
disease-modifying medicine
​​National guidelines recommendation regarding​ use in COVID-19 Ac​cess/go​vernance Supporting resources: 
NSW TAG COVID-19 resources​
​Dexameth​asone¥​Recommended for commencing in adults, including pregnant and breastfeeding women, receiving oxygen (including mechanically ventilated patients). Conditional recommendation for children and adolescents receiving oxygen (including those mechanically ventilated).  ​Via formulary ​NSW tag drug guidance (requires local DTC
endorsement)​​
​BARICITINIB​ Conditional recommendation for commencing in adults, who require supplemental oxygen, high flow oxygen and/or non-invasive ventilation.& Give with dexamethasone unless there is a specific contraindication.¥ Its effectiveness is not established when commenced after patient is mechanically ventilated. ​Via prescribing declaration/streamlined IPU*​NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent information; Prescribing Declaration/ Streamlined IPU* application form#; outcomes reporting form.
​Tocilizumab​Conditional recommendation for commencing in adults, pregnant and breastfeeding women, children or adults, who require supplemental oxygen, particularly where there is evidence of systemic inflammation.& Give with dexamethasone unless there is a specific contraindication.¥

​Critical Shortage: ONLY use when not possible to use baricitinib.

Via Prescribing Declaration  or Streamlined IPU*

NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent information:Prescribing IPU* application form# outcomes reporting form. Safety Alert 001/21
​SARILUMAB

​Conditional recommendation for commencing in adults, who require high-flow oxygen, non-invasive ventilation or invasive mechanical ventilation&

Give with dexamethasone unless there is a specific contraindication.¥

​If stock available, only use when not possible to use baricitinib or tocilizumab.

Via Streamlined IPU*

​Contact NSW TAG for drug guidance (requires local DTC endorsement); patient information; patient consent form; IPU* application form#; outcomes reporting form.

Requires SAS form to be completed.

CASIRIVIMAB PLUS IMDEVIMAB
(REGEN-COV)
​Conditional recommendation for commencing in seronegative patients** hospitalised with moderate to critical COVID-19. Not recommended in seropositive patients hospitalised with moderate to critical COVID-19.

​Currently eligible for TGA evaluation for provisional registration. Stock currently unavailable.

Via IPU*

​When/if available, see NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent form; IPU* application form#; outcomes reporting form.

Requires SAS form..

​SOTROVIMAB

​ See also ACI Model of Care              

​Via Prescribing Declaration/ Streamlined IPU*

 

​NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent form; Prescribing Declaration/ Streamlined IPU* application form#; outcomes reporting form. 

Antiviral therapy

Specific
disease-modifying medicine
​​National guidelines recommendation regarding​ use in COVID-19 Access/governance Supporting resources: 
NSW TAG COVID-19 resources​
​Remdesivir​Conditional recommendation for commencing in adults including pregnant or breastfeeding women who require oxygen but not ventilation. Note criteria and exceptions^Via Prescribing Declaration/Streamlined); or IPU* NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent form; Prescribing Declaration/Streamlined IPU* application form#;outcomes reporting form.

Other

Specific
disease-modifying medicine
​​National​ guidelines recommendation regarding​ use in COVID-19 Access/governance Supporting resources: 
NSW TAG COVID-19 resources​
  • Azithromycin
  • Colchicine
  • Convalescent
  • Plasma
  • Favipiravir
  • Hydroxychloroquine@
  • Interferon Beta-1a
  • Lopinavir/Ritonavir
​​Not recommended 

Do not commence for the

treament of COVID-19.

​-
​For other potential therapies, such as ivermectin see Australian Guidelines​Not recommended 

​Not recommended

outside clinical

 trial.

​¥ Other corticosteroids (prednisolone, hydrocortisone) are also considered appropriate if dexamethasone is not available- refer to Australian Guidelines for further information.
&. Not recommended for pregnant or breast-feeding women or children or adolescents outside the research setting
* IPU = Individual Patient Use – see below.
# check with Infectious Diseases/Pharmacy departments for access information and documentation
^ Conditional recommendation against use of remdesivir in children or adolescents with COVID-19 - refer to Australian Guidelines for further information.
**For children & adolescents and pregnant & breastfeeding women, certainty of benefit and safety has been downgraded due to absence or limited inclusion of these populations in the included studies.
@ applies to COVID-19 treatment or for pre- or post-exposure prophylaxis.
 

NSW Health does not endorse any specific antiviral or immunomodulatory therapy for patients with COVID-19, outside those treatments reco​mmended by the national COVID-19 clinical guidelines. Currently there are few circumstances where this might be considered (e.g. remdesivir slightly outside current criteria). In these rare circumstances, the following process should be followed.

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Access to Non-form​ulary and/or Off-Label Medicines in Hospital

Clinical decision making must align with the criteria for Off-Label Use of Medicines for “Exceptional/Individual Use” and “Conditional Use, with Evidence Development”, outlined in the Council of Australian Therapeutic Advisory Groups’ (CATAG)
Guiding principles​. Institutional governance is through the Individual Patient Use procedure, with shared decision making and informed consent involving the patient or carer, and entry of patient data into a registry for evidence development. Rigorous monitoring for adverse drug events and reporting of these is essential. Use of a registry will inform safer future use of treatments for COVID-19. Currently local sites are responsible for their own registry with collated information regarding IPUs reported through the usual process – refer to Approval process of Medicines for Use in NSW Hospitals​. State-wide registries are being established to facilitate the collection of information on use and outcomes for all NSW patients with COVID-19 who are given specific COVID-19 medicines outside a clinical trial. Further information is available at NSW TAG COVID-19 resources​.

Clinical trials

​​There are at least three clinical trials of specific medications for patients in hospital with COVID-19 with ethics approval in NSW, supported by NSW Health: 
  1. REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial which has randomised more than 11,000 ICU patients with suspected or proven COVID-19. (see REMAP-CAP). A wide range of antiviral, immunomodulatory therapies and other therapies are being evaluated. The study can adapt over time as the pandemic and other evidence develops: a statin domain and antibiotic domains (for COVID-19 patients with bacterial co-infection) are currently being evaluated in Australia. Other domains including an anticoagulation and renin-angiotensin system domains are pending.
  2. Australasian COVID-19 Trial (ASCOT). A multicentre, adaptive, randomised clinical trial to assess patients with SARS-CoV-2 infection (COVID-19) treated in hospital outside of ICU. ASCOT currently enrols each patient into two active domains: (i) anticoagulation (one of carefive different prophylactic or therapeutic anticoagulation regimens) and (ii) antiviral (nafamostat vs standard of care). See Australasian COVID-19 Trial 
  3. Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease (CLARITY) is a pragmatic prospective, open-label, randomised controlled trial investigating the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of hospital- and home-based adults who have tested positive for COVID-19 disease.​

There are other approved studies of therapies for prevention of COVID-19 as well as studies of other therapies for treatment, currently under ethics review and applications for funding.

This guidance will be updated regularly as new information becomes available. 

Resources

  •  Evidence on management is summarised in Australia with the Living Guidelines.
  • The recommended process to guide clinical decision making and governance of off-label use of medicines in Australia is described in the Council of Australian Therapeutic Advisory Groups (CATAG) Guiding principles.
  • Resources regarding use of specific COVID-19 therapies in hospitalised patients (patient/carer information and consent forms, drug guidelines and IPU/outcomes forms) and a summary of clinical trials approved in NSW are available from NSW TAG.
  • Worldwide clinical trials are listed at: Global Coronavirus COVID-19 Clinical Trial Tracker.
  • Australia and NZ clinical trials are listed at: Australian New Zealand Clinical Trials Registry (ANZCTR) (search COVID studies). 

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Document information

Developed by

Drug and therapeutics Advisory Community of Practice.

Consultation

Endorsed​ by

Dr Nigel Lyons, Deputy Secretary, Health System​ Strategy and Planning, NSW Ministry of Health.

Reviewed date

31 August 2021.

For u​se by

All communities of practice​.​​​​​​​​​​​​​​

​​
Current as at: Tuesday 31 August 2021
Contact page owner: Health Protection NSW