There are now multiple products authorized by the U.S. Food and Drug Administration (FDA) for the outpatient treatment and prevention of COVID-19. The primary goal of these medications is to reduce hospitalizations and deaths in high-risk patients with COVID-19. Please refer to this page for the latest guidance and resources on COVID-19 therapeutics.
Contents
Available COVID-19 Therapeutics
SARS-CoV-2 Negative (-)
| Pre-Exposure Prophylaxis (PrEP) | Post-Exposure Prophylaxis (PEP) |
Long-Acting Monoclonal Antibody - Tixagevimab/cilgavimab (Evusheld)
| Currently no authorized treatments |
SARS-CoV-2 Positive (+)
Treatment options, in order of preference: 1. Nirmatrelvir/ritonavir (Paxlovid) 2. Remdesivir (Veklury)
If above options are unavailable or not medically appropriate, can consider (in alphabetical order): 3. Bebtelovimab 4. Molnupiravir (Lagevrio) |
Treatment
Monoclonal Antibodies
Bebtelovimab 175 mg
given as a single intravenous injection | Intravenous | 12 years and older and weighing at least 40 kg | As soon as possible, but within 7 days of symptom onset | In low-risk adults, 34% relative reduction in viral load compared to placebo and a relative reduction in time to sustained symptom resolution compared to placebo. Currently there is no trial data to determine difference in clinical outcomes between placebo and treatment arms. | Effective against Omicron, including BA.2 subvariant |
Antivirals
Nirmatrelvir with ritonavir (Paxlovid) Orally twice daily for 5 days - For patients with normal/mild renal impairment (eGFR > 60 mL/min): 300 mg nirmatrelvir with 100 mg ritonavir
- For patients with moderate renal impairment (eGFR ā„ 30 to < 60 mL/min): 150 mg nirmatrelvir with 100 mg ritonavir
| Oral | 12 years and older and weighing at least 40 kg | As soon as possible, but within 5 days of symptom onset | Compared to placebo, a relative risk reduction of 89% in hospitalizations or deaths. | Effective against Omicron, including BA.2 subvariant |
Remdesivir (Veklury)
- For adults and pediatric patients weighing ā„ 40 kg: 200 mg IV on Day 1, followed by 100 mg IV daily on Days 2 and 3
- For pediatric patients ā„ 28 days old and weighing ā„ 3 kg to < 40 kg: 5 mg/kg IV on Day 1, followed by 2.5 mg/kg IV daily on Days 2 and 3.
| Intravenous | FDA approved for mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression.
| As soon as possible, but within 7 days of symptom onset | Compared to placebo, a relative risk reduction of 87% in hospitalizations or deaths. | Effective against Omicron, including BA.2 subvariant |
Molnupiravir (Lagevrio) 800 mg Orally twice daily for 5 days | Oral | 18 years and older | As soon as possible, but within 5 days of symptom onset | Compared to placebo, a relative risk reduction of 30% in hospitalizations or deaths. | Effective against Omicron, including BA.2 subvariant |
Pre-Exposure Prophylaxis:
Tixagevimab 300 mg / 300 cilgavimab mg (Evusheld) Given as two separate, consecutive injections | Intramuscular | 12 years and older and weighing at least 40 kg | Reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. | Effective against Omicron, including the BA.2 subvariant |
U.S. Department of Health and Human Services (HHS) summary table:
FDA approved/authorized COVID-19 drugs
Monoclonal antibodies are synthetic proteins that block virus from attachment and entry into human cells. With the predominance of the BA.2 Omicron subvariant throughout the United States, only one anti-SARS-CoV-2 monoclonal antibody, bebtelovimab, is currently authorized for COVID-19 treatment.
Additionally, there is one anti-SARS-CoV-2 monoclonal antibody, tixagevimab/cilgavimab (Evusheld), that is currently authorized for pre-exposure prophylaxis against COVID-19 in individuals who are immunocompromised or have a medical contraindication to COVID-19 vaccines. Notably, Evusheld is not a substitute for vaccination and should not be used in unvaccinated individuals for whom COVID-19 vaccination is recommended and who are anticipated to have an adequate response. Vaccination remains the most effective way to prevent SARS-CoV-2 infection, and it should be considered the first line of prevention.
General information on monoclonal antibodies:
Infusion locations
Bebtelovimab:
COVID-19 Pre-exposure Prophylaxis (with Evusheld)
Evusheld:
Antivirals prevent viral replication through multiple processes. There are currently two oral antivirals, nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio), that are authorized for outpatient treatment of COVID-19. Additionally, remdesivir (Veklury) is an intravenous antiviral that has FDA approval for inpatient and outpatient treatment of COVID-19 in adult and pediatric patients 28 days and older weighing at least 3 kg.
General Information on antivirals
Nirmatrelvir/ritonavir (Paxlovid):
Molnupiravir (Lagevrio):
Remdesivir (Veklury):
Multiple factors must be considered when selecting the appropriate treatment for outpatient with COVID-19. These include patient-specific factors such as clinical/medical conditions and potential drug-drug interactions; and healthcare system factors such as drug availability and feasibility of drug administration.
Treatment Guidelines
Treatment Algorithms (Flow Charts)
Drug Interaction Checker
COVID-19 Variant Information
Underlying Medical Conditions
HHS maintains a Therapeutic locator of sites that currently have outpatient therapeutics available.
The federal government launched the Test to Treat initiative to facilitate expedited access to testing, assessment, and treatment. Through this program, various clinic-based pharmacies provide on-site testing (including the evaluation of at-home test results), clinical assessment, and prescription and dispensing of COVID-19 oral antiviral medications.
Additionally, the California Department of Public Health (CDPH) and Optum Serve are upgrading testing sites to provide free and confidential testing and oral antiviral treatment to individuals who test positive and are eligible for COVID-19 treatment, including for uninsured, underinsured, undocumented, and unhoused individuals.
Therapeutics locator
Test to Treat Program ā General Information
Test to Treat Site Locator
CDPH Test to Treat Locations
On April 25, 2022, HHS transitioned from a weekly allocation distribution process to a weekly "threshold and replenishment" strategy. This new strategy is similar to the allocation process for vaccines and allows jurisdictions to order treatments throughout the week.
With the new threshold and replenishment strategy, each jurisdiction sets a threshold for Paxlovid, lagevrio, and bebtelovimab and each Monday, the federal government replenishes products equal to the amount ordered the previous week. This means that no supply is swept; threshold reset occurs each Monday to restore the full threshold amount.
The threshold and replenishment strategy applies to Evusheld as well. However, instead of a weekly threshold reset, Evusheld will follow a monthly schedule.
Thresholds will be determined using the same methodology as the previous weekly allocation: oral antivirals and Evusheld will continue to be determined on a pro-rata population basis while Bebtelovimab will remain disease-based.
Weekly state and territory-coordinated distribution method (September 13, 2021 ā April 24, 2022)
Threshold and replenishment distribution method (April 25, 2022 ā present)
Originally published on June 15, 2022