Update 24 March 2022

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Background

This guidance includes evidence-based recommendations, as well as resources to support therapeutic decision-making, drug access, governance and use in hospital, outpatient and community settings.   

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  24 March 2022, with guidance on access, governance and resources to support use in hospital. 

Additional summary guidances documents 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: 
​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 ​See NSW TAG Use of Dexamethasone for COVID-19 in hospitalised adults, adolescents and children drug guideline
Baricitinib(Olumant)Conditional recommendation for commencing in adults, who require supplemental oxygen, high flow oxygen and/or non-invasive ventilation (invasive or non-invasive)& 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*​See CEC resources - Medication safety updates

Tocilizumab(Actemra)

​Conditional recommendation for commencing in adults, pregnant and breastfeeding adolescents, 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*

​See CEC resources - Medication safety updates

Safety Alert 002/21

Safety Alert 001/21

Sarilumab (Kevzara)

​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*

​See CEC resources - Medication safety updates

Requires SAS form to be completed.

​Casirivimab Plus Imdevimab
(Ronapreve)
​Conditional recommendation for commencing

within 7 days of symptom onset in adults and pregnant women in the second or third trimester who do not require oxygen and who have one or more risk factors for disease progression.**

There is potentially a decreased effectiveness of casirivimab plus imdevimab against the Omicron variant, based on in-vitro data.

The National COVID-19 Clinical Evidence Taskforce also provides a conditional recommendation for the use of casirivimab and imdevimab in seronegative patients hospitalised with moderate to critical COVID-19.

Via Prescribing Declaration/Streamline   IPU*

​See CEC resources - Medication safety updates

See also ACI Model of Care

Sotrovimab(Xevudy)

 

Conditional recommendation for commencing in adults and pregnant women in the second or third trimester$ within 5 days of symptom onset and who do not require oxygen and have one or more risk factors for disease progression. ​       

​Via Prescribing Declaration/ Streamlined IPU*

 

​​See CEC resources - Medication safety updates

See also ACI Model of Care        

Tixagevimab and Cilgavimab (Evusheld)​Approved for pre-exposure prophylaxis in adults and adolescents (aged 12 years and older and weighing at least 40 kg):

-who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination (see ATAGI guidance regarding immunocompromise)

OR

-for whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction. &

​Via Prescribing Declaration/ Streamlined IPU*

​​See CEC resources - Medication safety updates

See also ACI Model of Care

Antiviral therapy

Specific
disease-modifying medicine
​​National guidelines recommendation regarding​ use in COVID-19 Access/governance Supporting resources: 

​Remdesivir(Veklury)

​Conditional recommendation for commencing in adults including pregnant or breastfeeding women who require oxygen but not ventilation and have one or more risk factors for disease progression.  Note criteria and exceptions^Via Prescribing Declaration/Streamlined); or IPU*

See CEC resources - Medication safety updates

Safety Notice 020/21

 

​Nirmatrelvir and Ritonavir (Paxlovid)​Conditional recommendation for commencing in adults within 5 days of symptom onset and who do not require oxygen and have one or more risk factors for disease progression to hospitalisation or death. &​Via Prescribing Declaration/ Streamlined IPU*

See CEC resources - Medication safety updates

See also ACI Model of Care

​Molnupiravir (Lagevrio)​Conditional recommendation for commencing in adults within 5 days of symptom onset and who do not require oxygen and have one or more risk factors for disease progression to hospitalisation or death.&​Via Prescribing Declaration/ Streamlined IPU*​See CEC resources - Medication safety updates

See also ACI Model of Care

Other

Specific
disease-modifying medicine
​​National​ guidelines recommendation regarding​ use in COVID-19 Access/governance Supporting resources
  • Azithromycin
  • Aspirin
  • 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.
$ Use in pregnant women in their second and third trimester is based on a conditional recommendation from the National COVID-19 Clinical Evidence Taskforce. Long term safety data is not available in this specific patient group.
@ 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 five 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-ADAPT). 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.​
  4. The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution. Once patients have consented to participate in the study, they will be randomised to receive either 6 mg oral dexamethasone or 150 mg thiamine (placebo). Target sample size is 650 patients.
  5. A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants with Coronavirus (COVID-19). This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60. Participants will receive the active drug or matching placebo for 14 days. Target sample size is 380 patients.

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

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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

24 March 2022

For u​se by

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

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Current as at: Tuesday 29 March 2022
Contact page owner: Health Protection NSW