Treatment Based Questions

# Treatment Based Questions

### Should dexamethasone be used to treat COVID-19 patients?
- Preliminary evidence from a UK-based randomized clinical trial (The recovery trial) suggests dexamethasone reduced mortality for patients on ventilators by about 33% and by 20% in patients requiring oxygen support. The study showed no benefit in patients with milder disease, there were also no preventive benefits.
- Currently, dexamethasone is not routinely used in COVID-19 patients except there are specific indications, i.e COPD exacerbation.
- Dexamethasone may be used cautiously on a case-by-case bases in patients who are severely ill and are on ventilation or oxygen support.

### 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.

### Following the retraction of the two articles that halted the use of hydroxychloroquine in COVID-19 patients, can I currently administer this medication to patients?
- Currently, hydroxychloroquine is not recommended for use outside of clinical trials due to its potential for toxicity and lack of documented benefits. The Emergency use authorization of hydroxychloroquine and chloroquine was revoked by the US FDA on JUNE 15th 2020, as the known potential benefits do not outweigh the potential risks and toxicity.

### Is every patient with a positive COVID-19 test required to be admitted to the hospital?
- Not all patients with COVID-19 require hospital admission.
- Patients whose clinical presentation warrants in-patient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions.
- Some patients with an initially mild clinical presentation may worsen in the second week of illness.
- The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis. This decision will depend not only on the clinical presentation, but also on the patients ability to engage in self-monitoring, the feasibility of safe isolation at home, and the risk of transmission in the patients home environment.

### Are there any FDA approved drugs(medicines) for COVID-19?
- Currently there are no FDA-approved medicines specifically approved for the treatment or prevention of COVID-19.
- During public health emergencies, the FDA may authorize the use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization (EUA).
- The FDA has issued EUAs for some medicines to be used for certain patients hospitalized with COVID-19.  Researchers are studying new drugs, and medicines that are already approved for other health conditions, as possible treatments for COVID-19.
- The FDA created the Coronavirus Treatment Acceleration Program (CTAP) to use every available method to move new treatments to patients.
- Additionally, the FDA is working with the National Institutes of Health, drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments.
- FDAs Sentinel System is being used to monitor the use of drugs, describe the course of illness among hospitalized patients, and evaluate the treatment impact of therapies actively being used under real-world conditions.

### Is Remdesivir approved by the FDA to treat COVID-19?
- No. Remdesivir is an investigational antiviral drug. It is not currently FDA-approved to treat or prevent any diseases, including COVID-19.  Because remdesivir may possibly help very sick patients, the FDA is allowing this drug to be provided to hospitalized patients with severe COVID-19 under an Emergency Use Authorization (EUA) issued May 1, 2020.
- Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. However, final data from clinical trials included in an FDA application for approval are necessary for us to determine whether the drug is safe and effective in treating COVID-19.

### Are empirical antibiotics recommended for patients suspected with having COVID-19?
- Several patients with COVID-19 have been reported to present with concurrent community-acquired bacterial pneumonia.
- Decisions to administer antibiotics to COVID-19 patients should be based on the likelihood of bacterial infection. (community-acquired or hospital-acquired), illness severity, and antimicrobial stewardship issues.

### What anti-viral medications are available to treat COVID-19?
- There are no drugs or other therapeutics presently approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19.
- Current clinical management includes infection prevention and control measures and supportive care, including supplemental oxygen and mechanical ventilatory support when indicated. There are many ongoing clinical trials in the US and around the world for the treatment of COVID-19.

### Can persons take Ivermectin to prevent or treat COVID-19?
- No. While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19.
- One should not take any medicine to treat or prevent COVID-19 unless it has been prescribed by a health care provider and acquired from a legitimate source.
- A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.

### Do NSAIDs worsen the course of disease for people with COVID-19?
- CDC is currently not aware of scientific evidence establishing a link between NSAIDs (e.g., ibuprofen, naproxen) and worsening of COVID19.
- FDA external, the European Medicines, the World Health Organization, and CDC are continuing to monitor the situation and will review new information on the effects of NSAIDs and COVID-19 disease as it becomes available.
- For those who wish to use treatment options other than NSAIDs, there are other over-the-counter and prescription medications approved for pain relief and fever reduction.
- Patients who rely on NSAIDs to treat chronic conditions and have additional questions should speak to their healthcare provider for individualized management.
- Patients should use NSAIDs, and all medications, according to the product labels and advice of their healthcare professional.

### Are There any vaccines or other medical products to prevent COVID-19?
- At this time there is no vaccine to prevent COVID-19.
- The FDA is working with the vaccine developers and other researchers and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies, and drugs to prevent COVID-19.

### What is convalescent plasma and why is it being investigated to treat COVID-19?
- Convalescent plasma is the liquid part of blood that is collected from patients who have recovered from the novel coronavirus disease, COVID-19, caused by the virus SARS-CoV-2.
- COVID-19 patients develop antibodies in the blood against the virus. Antibodies are proteins that might help fight the infection.
- Convalescent plasma is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease and there is some information that suggests it might help some patients recover from COVID-19. Further investigation is still necessary to determine if convalescent plasma might shorten the duration of illness, reduce morbidity, or prevent death associated with COVID-19.