The Covid-19 sub-committee of the National Essential Medicines List Committee is updating its recommendations on the use of corticosteroids in the treatment of Covid-19, the Health Ministry says, in light of the initial clinical trial results on the use of dexamethasone.
Previously, given what it deemed the "lack of effectiveness and possible harm previously seen", it had recommended that "routine corticosteroids should be avoided" in most instances. But it has changed its stance while waiting to make a full assessment of the UK trial results that show dexamethasone, a corticosteroid, can be lifesaving for patients who are critically ill with Covid-19.
For patients on ventilators, the dexamethasone treatment was shown to reduce mortality by about a third and for patients requiring only oxygen mortality was cut by about one fifth, according to preliminary findings shared with the World Health Organisation (WHO) yesterday.
In welcoming the news, the world health body said: "WHO will coordinate a meta-analysis to increase our overall understanding of this intervention. WHO clinical guidance will be updated to reflect how and when the drug should be used in Covid-19."
Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone. There was no benefit among those patients who did not require respiratory support.
The benefit was only seen in patients seriously ill with Covid-19 and was not observed in patients with milder disease.
Dexamethasone is a steroid that has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders and certain cancers. It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordably available in most countries.
The use of corticosteroids for the treatment of Covid-19 in South Africa is currently defined in the National Department of Health’s Clinical Management of Suspected or Confirmed Covid-19 Disease (version 4, 18th May 2020).
It states that "Given the lack of effectiveness and possible harm previously seen, routine corticosteroids should be avoided unless they are indicated for other reasons, such as an asthma or COPD exacerbation".
The Health Ministry said the full publication of the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial is eagerly awaited.
"There are important aspects of the results that will be needed to make a full assessment of the data, none more so than the number and type of adverse events in the dexamethasone arm vs standard of care.
"This is critical information needed to provide definitive guidance. Data on the absolute risk reduction and the numbers of events per patient group will also be needed to fully interpret the evidence provided.
"In the interim, we believe that intravenous dexamethasone 6mg daily or an equivalent oral corticosteroid (such as prednisolone 40mg daily) for 10 days may be considered in patients with a confirmed diagnosis of Covid19 who are being mechanically ventilated.
"Although a lesser effect on mortality was shown in those patients requiring oxygen but not being mechanically ventilated, we also advise that dexamethasone may be considered for patients admitted to hospital with Covid-19 who require oxygen support but are not mechanically ventilated, especially those requiring high-flow nasal oxygen, CPAP, or non-invasive ventilation.
"Patients admitted to hospital with a confirmed or suspected diagnosis of Covid-19 who do not require oxygen support should not receive dexamethasone or other corticosteroid, unless clinically indicated for a specific comorbidity.
"Contraindications to dexamethasone and adverse effects are detailed in the EML and South African Medicines Formulary, and clinicians are encouraged to refer to these resources.
"As oral dexamethasone is only accessible as a Section 21 medicine, an equivalent oral corticosteroid may be used.
"The RECOVERY trial included either oral prednisolone (40mg daily) or intravenous hydrocortisone (80mg twice daily) in pregnant and breast-feeding women. Betamethasone is a further oral option. 6.
"It must be stressed that this advisory is based on a preliminary statement by the chief investigators of the RECOVERY trial, and this advisory may be subject to change following review of the full publication."