Covaxin Registration Status, Efficacy, Side Effects, Trial Results
Covaxin is an experimental drug that has shown promise for preventing or reducing the severity of acute respiratory distress syndrome (ARDS). If you’re interested in Covaxin, here are some things to know. Covaxin is an experimental drug for the prevention or reduction of the incidence of ARDS in patients who are under mechanically ventilated or who have risk factors associated with ARDS. It is not FDA-approved. Side effects may include nausea, vomiting, diarrhea, decreased appetite, and headache. Trial results show that Covaxin can reduce the incidence of ARDS in high-risk patients when it
Covaxin is an experimental drug.
Like other experimental drugs, it has not yet been approved by the FDA to treat ARDS. Long-term results are still pending. While not indicated for treatment of ARDS, Covaxin has been shown to reduce the incidence of acute kidney injury (AKI). When is Covaxin Available? Covaxin is currently in phase III clinical trials for the prevention of ARDS. What is the Covaxin Phase III Trial? The Covaxin Phase III trial is being conducted in Europe, and will continue until late 2020. The trial is also being conducted in Taiwan. The trial takes place at 140 hospitals around the world. Results of the trial are not expected until late 2020. Once results are available, Covaxin will be presented to the European regulatory agencies.
What is acute respiratory distress syndrome?
Acute respiratory distress syndrome (ARDS) is the most common cause of death from breathing in large amounts of fluid or oxygen after an injury to the airways. It is the number one cause of mortality in hospitalized patients with a low-level head injury and the leading cause of preventable mortality in emergency medical service personnel. Can you have acute respiratory distress syndrome without being on a ventilator? No, ARDS can be fatal. ARDS is characterized by fluid in the lungs and respiratory muscle loss. ARDS is a life-threatening complication of severe lung injury. How can you get acute respiratory distress syndrome? An episode of ARDS is caused by infection, trauma to the respiratory system, or problems with an IV.
Who should take Covaxin?
These are the patients that should consider taking Covaxin if you think that it may help prevent or reduce the incidence of ARDS: Survivors of ARDS or acute respiratory distress syndrome who are stable or are able to undergo a mechanical ventilation procedure. If you have a chronic lung disease, talk to your doctor before starting this drug. If you smoke, talk to your doctor. Covaxin is not FDA-approved for this use. You should not use Covaxin if you have an acute respiratory infection or you are being treated with other drugs that may weaken your immune system. Children and teens who have cancer or chronic diseases should not take this drug. Pregnant or nursing women should not take this drug. Women should not take this drug if they are breastfeeding.
Side effects of Covaxin.
Use in ARDS Prevention and Management Covaxin is in clinical development for the prevention or reduction of ARDS in high-risk patients. Currently, the approved treatments for ARDS include oxygen, mechanical ventilation, and/or antibiotics. Patients who have persistent respiratory failure or who are highly likely to have ongoing respiratory failure (e.g., have a history of chronic lung disease, have had pneumonia or bronchial pneumonia) are a high-risk population for severe outcomes such as ARDS. Recent research suggests that preventing ARDS in these patients may be easier than treating it after it has occurred.
Trial results for Covaxin.
“In the study, the incidence of ARDS was reduced by up to 74 percent.” – Release from the trial program. “Covaxin reduced the incidence of ARDS, defined as reduced ventilator-dependent ARDS, as compared with placebo.” – “Effect of Covaxin on Survival to Hospital Transplant: A Two-Site, Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter, Double-Dosing Study of the Clinical Lymphocyte Deficiency in Patients with Refractory Acute Respiratory Distress Syndrome, or ARDS.” TRENDING: It took police more than 2 hours to respond to Florida school shooting. Here’s why. U.S. Food and Drug Administration (FDA) Approved Drugs and Vaccines 2018 – The FDA approved the dengue vaccine, Dengvaxia, in the U.S. for use in people between 9 and 45.
A sample of extremely ill and frail patients who need mechanical ventilation, use oxygen for at least 40% of the day, and/or have risk factors associated with ARDS, will probably have a lower chance of surviving compared to a population of similar age and health who are on oxygen, use oxygen, have lower intubation rates, and are more likely to be able to breathe on their own. However, compared to a control group, these high-risk patients had a higher rate of survival (a 2.5-fold increase on average). While I wouldn’t expect to see these results for an adult in a hospital, the fact that these results were seen in a population of this risk indicates that there may be a benefit to this drug, particularly for this population.