Current COVID-19 Treatment Guidelines
February 2022
What is the FDA’s current status on the medications used for the management of COVID-19?
So far, the FDA has approved only one drug for the treatment of COVID-19 and issued emergency use authorization (EUA) on several drugs to be used to treat and/or prevent COVID-19.
What is the difference between an FDA-approved drug and an Emergency Use Authorization (EUA)?
• An FDA-approved drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling.
• An Emergency Use Authorization (EUA) is a mechanism the FDA uses to facilitate the availability and use of medical countermeasures such as vaccines, blood products, drugs, etc. during public health emergencies. An example of a public health emergency is the current COVID-19 pandemic.
• Under an EUA, the FDA may authorize the use of unapproved drugs or unapproved uses of approved drugs under certain conditions.
What is currently approved, or authorized medications used to treat COVID-19?
Approved | Veklury (Remdesivir) |
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Authorized | Molnupiravir, Paxlovid, REGEN-COV, Baricitinib, Evusheld, Actemra, Sotrovimab, Propofol-Lipuro 1%, Bamlanivimab and Etesevimab, REGIOCIT, Fresenius Kabi Propoven 2%, COVID-19 convalescent plasma |
What are some alternative treatments to authorized medications for COVID-19?
• Ivermectin
• Monoclonal Antibody Therapy
• Systemic Corticosteroids
What is some pertinent information about the medications that have been used to manage COVID-19 since the pandemic?
Hydroxychloroquine | Not recommended for use in COVID-19. Had an initial EUA from the FDA in March of 2020 which was soon revoked due to the risk of heart rhythm problems. Taking hydroxychloroquine to treat COVID-19 may increase the risk of heart rhythm problems, blood and lymph disorders, kidney injury, liver problems, and failure. |
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Ivermectin | Ivermectin is not authorized or approved by FDA for the prevention or treatment of COVID-19. The National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19 WHO advises that ivermectin only be used to treat COVID-19 in clinical trials. Some clinical trials suggest it is safe and effective in treating and preventing COVID-19. Currently been used by some clinicians to treat and prevent COVID-19 Side effects of Ivermectin include headache, dizziness, muscle pain, nausea, or diarrhea. |
Monoclonal Antibody Therapy | The FDA issued an authorization for the use of monoclonal antibodies therapy (REGEN-COV) in mild to moderate COVID-19 cases in adults at risk of progressing to severe COVID-19. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Data from a phase 3 portion of a randomized, double-blind, placebo-controlled clinical trial in 4,567 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and at least one risk factor for severe COVID-19 showed that high-risk outpatients with mild-to-moderate COVID-19 demonstrated a similar reduction in risk of hospitalization or death with either the lower doses or the higher doses of REGEN-COV, administered together, compared to placebo. REGEN-COV is currently granted an emergency authorization to be used for both treatment and post-exposure prophylaxis for COVID-19. Common side effects reported include fever, hypoxia, arrhythmia, fatigue, and altered mental status. Some infusion-related side effects reported include fever, chills, nausea, headache, bronchospasm, and hypotension. Monoclonal Antibody Therapy is available in infusion centers across the country. Click here to find a center near you. |
Paxlovid | The FDA has issued an emergency use authorization of Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results and who are at high risk of progressing to severe COVID-19. Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. The EPIC-HR trial, which was a randomized, double-blind, placebo-controlled clinical trial, studying Paxlovid for the treatment of 1039 non-hospitalized symptomatic adults found that Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. Some side effects include altered taste, diarrhea, hypertension, and muscle pain. Paxlovid costs approximately $530 per course but will be available at the pharmacy at no cost to people in the US during the public health emergency. |
Molnupiravir | The FDA has issued an emergency use authorization for Molnupiravir to treat mild-to-moderate COVID-19 in adults with a positive test at risk of progression to severe COVID-19 for whom other options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. From the MOVe-OUT trial, the main outcome measured was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Of the 709 people who received molnupiravir, 6.8% were hospitalized or died within this period compared to 9.7% of the 699 people who received a placebo. Of the people who received molnupiravir one died during the follow-up period compared to nine people who received placebo. Side effects observed include diarrhea, nausea, and dizziness. Molnupiravir costs approximately $700 per course but will be available at the pharmacy at no cost to people in the US during the public health emergency. |
Remdesivir | The only FDA-approved antiviral drug, Veklury (remdesivir), for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Remdesivir is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication. The approval of Remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Remdesivir shortened hospitalization by an average of 4 days. Side effects reported include nausea, rash, anaphylaxis, infusion-related reactions, and increased liver enzymes Remdesivir costs approximately $520 per vial for those with private insurance and $390 per vial for those without insurance. A treatment course is 6 vials. |
Dexamethasone | Recommended in patients requiring hospitalization and supplemental oxygen. Multiple randomized trials indicate that systemic corticosteroid therapy such as dexamethasone improves clinical outcomes and reduces mortality in hospitalized patients with COVID-19 who require supplemental oxygen |
What are recommended or supporting vitamins/supplements that may aid in immune system support against viruses or infections?
Vitamin C
Vitamin C is an essential water-soluble nutrient, required as a cofactor for several enzymatic reactions. Its effects on the immune system during infection include the promotion of phagocytosis and chemotaxis of leucocytes and the development and maturation of T-lymphocytes thereby helping boost the immune system.
Quercetin
Quercetin has antioxidant and anti-inflammatory effects that might help reduce swelling, kill cancer cells, control blood sugar, and help prevent heart disease.
Vitamin D3
Vitamin D3 is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Some studies have suggested that Vitamin D deficiency may increase the risk of COVID-19 infection and the likelihood of severe disease.
Melatonin
Melatonin supplementation promotes sleep and is safe for short-term use.
Zinc
Zinc helps boost the immune system and metabolism function. Zinc is also important in wound healing and sense of taste and smell.
Magnesium
Magnesium supports muscle and nerve function and energy production.
What are the current guidelines for Covid exposure and positive Covid test?
If you were exposed to COVID-19 and are NOT up to date on COVID-19 vaccinations: | • Quarantine for at least 5 days • Wear a well fitted mask around people for 10 full days • Even if no symptoms, get tested at least 5 days after exposure • Avoid being around people who are at high risk • Avoid travel |
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If you were exposed to COVID-19 and are up to date on COVID-19 vaccinations: | • You do not need to quarantine unless you develop symptoms • Even if no symptoms, get tested at least 5 days after exposure • Watch out for symptoms until Day 10 of exposure • Avoid being around people who are at high risk • Avoid travel |
If you were exposed to COVID-19 and have tested positive for COVID-19 within the past 90 days: | • You do not need to quarantine unless you develop symptoms • Watch ut for symptoms until Day 10 of exposure • Avoid being around people who are at high risk • Avoid travel |
If you tested positive for COVID-19 or have symptoms regardless of vaccination status: | • Stay home for at least 5 days • Wear a well fitted mask if you must be around people • End isolation after 5 full days if you are fever-free for 24 hours (without the use of fever-reducing medication) and your symptoms are improving • If you did not have no symptoms, end isolation after at least 5 full days after positive test • If you were severely ill, isolate for at least 10 full days, consults your doctor before ending isolation • Avoid being around people who are at high risk • Avoid travel |
Sources:
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
https://www.fda.gov/consumers/consumer-updates/know-your-treatment-options-covid-19
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs https://nutritionj.biomedcentral.com/articles/10.1186/s12937-021-00727-z
https://www.webmd.com/vitamins/ai/ingredientmono-294/quercetin
https://pubmed.ncbi.nlm.nih.gov/34607398/
https://www.mayoclinic.org/drugs-supplements-melatonin/art-20363071
https://www.mayoclinic.org/drugs-supplements-zinc/art-20366112
https://www.mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/magnesium-supplements/faq-20466270 https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html#:~:text=Get%20tested%20at%20least%205%20days%20after%20your%20first%20exposure,the%20person%20with%20COVID%2D19. https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/ https://www.fda.gov/media/143894/download
https://combatcovid.hhs.gov/possible-treatment-options-covid-19/monoclonal-antibodies-high-risk-covid-19-positive-patients
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19#:~:text=Today%2C%20the%20U.S.%20Food%20and,of%20age%20and%20older%20weighing
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https://www.fda.gov/media/155050/download
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https://www.fda.gov/media/137566/download
https://www.ajmc.com/view/gilead-sciences-sets-us-price-for-covid19-drug-at-2340-to-3120-based-on-insurance