EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no oxygen. Invasive ventilation involves use of a machine to push air through a tube inserted into the patient’s airway.
The RECOVERY study recorded deaths during 28 days after starting dexamethasone treatment. Preliminary results indicate that, compared with usual care, dexamethasone:
- reduced mortality by about 35% in patients on invasive mechanical ventilation;
- reduced mortality by about 20% in patients receiving oxygen without invasive ventilation;
- did not reduce death in patients who were not receiving oxygen therapy.
The review aims to provide an opinion on the results of the RECOVERY study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19.
EMA will communicate further when the review is complete.
More about the medicine
Dexamethasone is a corticosteroid medicine that has been authorised in the EU by national medicines authorities and has been available for several decades. It can be used by mouth and by injection for treating a range of inflammatory conditions and for reducing the body’s immune response in the treatment of allergies and autoimmune diseases. It is also used with cancer medicines to treat certain cancers and to prevent vomiting.
More about the procedure
The review of dexamethasone has been initiated at the request of the EMA Executive Director under Article 5(3) of Regulation 726/2004 following preliminary discussion with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.
The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will issue a scientific opinion within the shortest possible timeframe. The scientific opinion is then published and can be taken into account by EU member states when evaluating medicines.
NCT04503096Not yet recruitingConditions: Mild Cognitive Impairment
NCT04503109RecruitingSpinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation SystemConditions: Pain, Chronic; Pain, Intractable; Pain, Back
NCT04503122Not yet recruitingConditions: Paroxysmal Atrial Fibrillation
NCT04503135Not yet recruitingConditions: Central Venous Catheters; Central Venous Catheter Thrombosis; Thrombosis, Venous; Intensive Care Unit
NCT04503148Not yet recruitingConditions: Renal Cell Carcinoma
NCT04503161Not yet recruitingThe Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base SurgeryConditions: CSF Leak
NCT04503174Not yet recruitingConditions: Diabetes Mellitus, Type 1
NCT04503187RecruitingConditions: Stroke; Multiple Sclerosis
NCT04503200Not yet recruitingDouble Guidewire Technique Versus Transpancreatic Precut in Patients With Repetitive Unintentional Cannulation of the Pancreatic Duct.Conditions: Endoscopic Retrograde Cholangiopancreatography; Common Bile Duct Diseases; Transpancreatic Precut; Precut; Double Guidewire
NCT04503213Enrolling by invitationConditions: CSF1R-related Leukoencephalopathy; ALSP; POLD; Hematopoietic Stem Cell Transplantation
Featured Contract Research Organizations
As a partner for IT in the healthcare sector, Johner Institut GmbH supports companies in the development and approval of medical devices (medtech and...
BIOMAPAS CODE OF ETHICS is a company guide to appropriate conduct. Most of the Policies in this Code are based on laws, regulations and business, ethi...
A2 Healthcare Corporation
It is my great pleasure to inform you that A2 Healthcare Corporation, starting its operation in November 2014 as a newly integrated company, has succe...
Clinical testing is a vital part of disease diagnosis and treatment decisions, as well as health checkups. Our company mission is to contribute to qua...