Q&A: Dexamethasone and COVID-19 (Part -1)

New Delhi, June 25, 2020:

Q1. “What is dexamethasone and does it work against COVID-19?”

Dexamethasone is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.It was tested in hospitalized patients with COVID-19 in the United Kingdom’s national clinical trial RECOVERY and was found to have benefits for critically ill patients.

According to preliminary findings shared with WHO (and now available as a preprint), for patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth.

Q2. “Were all patients in RECOVERY given dexamethasone?”

Eligible patients were randomly allocated between several treatment arms. Dexamethasone was administered as an oral (liquid or tablets) or intravenous preparation, at a dose of 6 mg once daily for ten days, in one of the arms.

In pregnancy or breastfeeding women, patients were randomized to prednisolone (a milder corticosteroid) 40 mg administered by mouth.

Q3. “Does WHO recommend the use of dexamethasone for COVID-19 patients?”

WHO is in the process of updating treatment guidelines to include dexamethasone or other steroids.

Q4. “Is dexamethasone on the WHO Essential Medicines List?”

Yes, dexamethasone has been on the WHO Model List of Essential Medicines (EML) since 1977 for several indications in multiple formulations. Since 2013, dexamethasone (Injectable formulation) has been indicated for respiratory distress syndrome in new-borns. Prednisolone is also on the EML and was included in 1984.

Dexamethasone and prednisolone are included on the EML for the following indications:

allergic or hypersensitivity conditions, without further specifying the type
pain and oedema due to malignancy in palliative care
nausea and vomiting,
as part of treatment protocols for some blood tissue cancers.

These indications are broad and can also include cytokine-related lung injury and as prevention or treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory infections (i.e. viral pneumonia). Both medicines are also recommended in children

Q5. “Is dexamethasone prequalified by WHO?”

Yes, dexamethasone solution for injection 4mg/ml in 1ml ampoules, manufactured by Kern Pharma SL, Spain, has been prequalified for its use in the management of diseases associated with HIV/AIDS, but not for COVID-19. Another dexamethasone injection product is currently under assessment.

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