In its revised protocol for clinical management of Covid-19, the health ministry has decided to include the steroidal drug, dexamethasone, for the treatment of moderate to severe disease. Dexamethasone is being recommended as an alternative choice to the other corticosteroid medication, methylprednisolone.
Dexamethasone has shown to reduce mortality by one-third in the RECOVERY trial—a randomised controlled trial (RCT)—that began in March in the UK. An RCT is considered the gold standard in determining drug efficacy.
The results of the trial on dexamethasone were announced on June 16, and revealed that the drug reduced deaths by one-third in ventilated patients, and by one-fifth in patients receiving oxygen therapy only. “Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone,” the trial investigators stated.
“The change has been made after considering the latest available evidence and expert consultation. Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressive effects,” the health ministry said on Saturday.
For patients with progressive deterioration of oxygenation indicators, rapid worsening of imaging and excessive activation of the body’s inflammatory response, glucocorticoids can be used for a short period of time (three to five days), the protocol reads. “It is recommended that (the) dose should not exceed the equivalent of methylprednisolone 1– 2mg/kg/day OR Dexamethasone 0.2-0.4 mg/kg/day," according to the protocol.
The protocol cautions that a larger dose of glucocorticoid will delay the removal of coronavirus due to “immunosuppressive effects”.
Dexamethasone is also a part of the National List of Essential Medicines (NLEM) and is widely available, according to the ministry.
Union Health Secretary Preeti Sudan has also shared the updated protocol with all states and Union Territories to make necessary arrangements for availability and use of the updated protocol and drug dexamethasone at the institutional level also, the health ministry added.
However, experts caution that while the efficacy of the drug has been proven, this may lead to an irrational use of the drug in India. “Given that the drug is cheap, my worry is that it may lead to it being prescribed as soon as someone has a fever or develops cough. The concern is that it might be seen as a magic bullet,” said Dr S.P. Kalantri, who heads the internal medicine unit at Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha.
The revised clinical management protocol includes the use of Remdesivir in severe cases, and the antimalarial hydroxychloroquine for early management of the disease. However, favipiravir, which has been approved by the drug regulator for mild to moderate disease has not found mention in the health ministry’s document.
