Mkhize lauds new Covid-19 treatment

Minister of Health Dr Zweli Mkhize announced the use of a drug as a new treatment for Covid-19 in South Africa following a breakthrough in the Covid-19 therapeutics research.

“We are extremely excited that there has been an important breakthrough in one of the therapeutic trials for Covid-19 management,” he said in a statement on Tuesday.

Mkhize said the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial published results on the therapeutic merits of low dose dexamethasone which will be easily implementable in South Africa.

“Dexamethasone is a well known and widely used steroid which has potent anti-inflammatory properties. It is used in allergic reactions, asthma and other conditions where the inflammatory component of the disease needs to be controlled for better outcomes.

“We are very pleased that the Ministerial Advisory Committee on Covid-19 has issued an advisory pertaining to the clinical applications of these breaking study results,” he said.

The minister said the use of corticosteroids for the treatment of Covid-19 in South Africa was currently defined at the health department’s clinical management of suspected or confirmed Covid-19 disease.

“In summary, it states that given lack of effectiveness and possible harm, previously seen routine corticosteroids should be avoided unless they are indicated for other reasons, such as asthma or chronic obstructive pulmonary disease (COPD) exacerbation,” he continued.

He further said the Covid-19 sub-committee of the national essential medicines list (EML) committee was currently updating their recommendations on the use of corticosteroids in Covid-19.

“On 16 June, a statement was issued from the chief investigators of the Recovery trial, a UK-based adaptive trial of various potential treatments for Covid-19, one of which was a systemic corticosteroid (dexamethasone, prednisolone or hydrocortisone).

“The dexamethasone arm of the trial compared dexamethasone 6mg orally or intravenously once daily for 10 days (or prednisolone 40mg daily orally/hydrocortisone 80mg twice daily intravenously, in pregnant or breast-feeding women) against standard of care,” he added.

Mkhize continued to say that a total of 2,104 patients were randomised to receive dexamethasone 6mg once per day, either by mouth or by intravenous injection, for 10 days and were compared with 4,321 patients randomised to usual care alone.

He said among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%).

“Dexamethasone reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support.

“Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone. As the steering committee of the Recovery considered that a meaningful benefit of dexamethasone had been demonstrated, further recruitment to the dexamethasone arm of the study has been stopped,” he said.

Mkhize said the full publication of this part of the Recovery trial was 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 caret.

“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 Covid-19 who are being mechanically ventilated,” he said.

The minister further said 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, constant positive airway pressure (CPAP), or non-invasive ventilation,” he added.

He said 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 corticosteroids, unless clinically indicated for a specific comorbidity.

“Contraindications to dexamethasone and adverse effects are detailed in the EML and South African Medicines Formulary (SAMF), 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,” he continued.

Mkhize said the Recovery trial also included either oral prednisolone (40mg daily) or intravenous hydrocortisone (80mg twice daily) in pregnant and breast-feeding women, meanwhile, betamethasone was a further oral option.

“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,” he concluded.

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