There are several approved outpatient treatments for patients with mild to moderate symptoms of COVID-19 that have been shown to prevent progression to severe disease, hospitalization and/or death.  The current treatments include monoclonal antibodies (Sotrovimab) and antivirals (Paxlovid, Molnupiravir and Remdesivir). Each of these medications are appropriate for patients who have mild to moderate disease, do not require oxygen or hospitalization, are within a specific time frame of symptoms and have a characteristic, either by age or comorbid condition, that puts them at risk for progression to severe disease. Read on—and to ensure your health and the health of others, don’t miss these Sure Signs You’ve Already Had COVID.

Monoclonal Antibody. Treatment within 10 days of symptoms. 

Sotrovimab is a monoclonal antibody that binds to part of the SARS-CoV2 virus (COVID) that has not mutated much.  As a result, it is effective against Alpha, Delta, Gamma, Lambda and the Omicron variants.  The monoclonals previously produced by Regeneron and Eli Lilly target the spike proteins that frequently mutate and, as a result, are not effective against the current Omicron variant.  This is likely a result of the 30 point mutations in Omicron’s spike protein.  There has been some confusion about this in the general public but, given the fact that the current circulating SARS-CoV2 variant is over 99% Omicron, Sotrovimab is the monoclonal antibody of choice for treatment.  The other monoclonal antibodies produced by Eli Lilly and Regeneron are not currently effective.  Sotrovimab is produced by Glaxosmithkline and has an Emergency Use Authorization (EUA) issued by the FDA.  It can be used to treat the following qualifying patients under the EUA: confirmed positive COVID test, age 12 years or older (weighing at least 40 kg), a patient having mild to moderate symptoms without hypoxia and who has a characteristic that puts the patient at risk of severe COVID.  Treatment can be initiated within 10 days of symptoms assuming there are no contraindications.  The characteristics that increase risk of severe disease for COVID-19 are listed on the CDC site and include individuals age 65 or older or people with one or more of the following conditions:

• Cancer and treatment 
• Chronic kidney disease and chronic liver disease
• Chronic lung diseases – e.g., Asthma, COPD, Cystic Fibrosis, ILD, Pulmonary HTN
• Dementia or other neurological conditions 
• Diabetes (type 1 or type 2)
• Down syndrome
• CHF, CAD, cardiomyopathy 
• HIV infection or immunocompromised state 
• Obesity – BMI > 25 kg/m2
• Pregnancy 
• Sickle cell disease or thalassemia
• Smoking
• Solid organ or blood stem cell transplant
• Stroke or cerebrovascular disease

See CDC website for the full list. 

In a double-blinded, placebo-controlled trial, Sotrovimab was administered to patients with mild to moderate COVID symptoms with characteristics increasing likelihood of severe disease.  Patients with severe COVID (short of breath at rest or hypoxia) and those admitted for COVID-19 symptoms were excluded.  Treatment with this monoclonal antibody decreased the risk of hospitalization or death by 85% when compared to the placebo group. 

Treatment within 5 days of symptoms. 

Another treatment option is oral Paxlovid.  This medication is produced by Pfizer and recently received an EUA from the FDA.  The medication’s protease activity interferes with viral replication.  The EUA allows initiation of this oral anti-viral medication within 5 days of symptoms.  Patients, under the EUA, must be 12 years or older, weigh at least 40 kg, have a characteristic that puts them at high risk of severe disease progression and have mild to moderate symptoms at the time of treatment.  Again, they cannot be hypoxic or require admission to the hospital for COVID-19.  The medication is contraindicated for patients with significant renal impairment (GFR<30).  Also, if a patient has some impaired kidney function, the protease component may need to be given at ½ the dose.  Also, Paxlovid is contraindicated in patients with severe liver impairment.  In addition, Paxlovid has many interactions with other medications.  So, please discuss all these details with your doctor.  

In a double-blinded, placebo-controlled trial, Paxlovid decreased hospitalization and death 88% when given to unvaccinated, high-risk patients within 5 days of mild to moderate COVID symptoms.  It is currently available in limited quantities at specific pharmacies.  

Treatment within 5 days of symptoms. 

Molnupiravir is an oral antiviral medication that is produced by Merck.  It received an EUA for patients 18 years or older, with high-risk characteristics of disease progression and mild to moderate disease within 5 days of symptoms.  The antiviral drug works by creating errors in the viral RNA replication and, thus, inhibiting viral replication itself.  The drug is contraindicated in pregnancy and in severe COVID disease.  A double blinded, placebo-controlled trial showed that this medication decreased hospitalization and death by 31% when treatment was initiated within 5 days of symptoms.  The patients in this study were unvaccinated, 18 years or older, had mild to moderate symptoms and had at least one risk factor for severe COVID.  The FDA issued an EUA for this drug but stated that it is contraindicated in pregnancy.  Also, the FDA recommended using it only if other alternative outpatient treatments were not available.  Bottom line, Paxlovid or Sotrovimab are favored over this treatment but it is recommended as an alternative. 

 

Treatment within 7 days of symptoms. 

Remdesivir is frequently given to inpatients with severe COVID symptoms.  Now, Remdesivir can also be used as an outpatient medication to prevent progression of COVID symptoms.  In a recent study published in The New England Journal of Medicine, early outpatient treatment with Remdesivir was shown to decrease disease progression.  In a double-blinded, placebo-controlled trial, unvaccinated patients with mild to moderate COVID symptoms, with at least one risk factor for severe disease, were treated with a 3-day outpatient course of Remdesivir. This resulted in an 87% decreased risk of hospitalization and death in the treatment group compared to the placebo group.  The FDA has issued an EUA for Remdesivir based on this data.  The medication can be administered to COVID positive patients within 7 days of symptoms, with mild to moderate disease and at least one risk factor, by age or comorbid condition, for disease progression.  Like Sotrovimab, administration of Remdesivir requires an outpatient or inpatient setting as well as nursing/physician supervision. As a result, these IV infusions may be limited by bed capacity and staff resources given the current surge and hospital capacity issues.  

Given the limited supply of outpatient treatments, the NIH has issued guidance for prioritizing specific high-risk patients over the general public.  These are simply recommendations, but given the limited supplies, many hospitals/physicians are likely to use such a framework or similar criteria to allocate medications in order to have the greatest impact. See here for more.

Risk Group 1

Immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection due to their underlying conditions, regardless of vaccine status (see Immunocompromising Conditions below); or

Unvaccinated individuals at the highest risk of severe disease (anyone aged ≥ 75 years or anyone aged ≥ 65 years with additional risk factors).

Risk Group 2

Unvaccinated individuals at risk of severe disease not included in Tier 1 (anyone aged ≥ 65 years or anyone aged < 65 years with clinical risk factors)

Risk Group 3

Vaccinated individuals at high risk of severe disease (anyone aged ≥ 75 years or anyone aged ≥ 65 years with clinical risk factors)

Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment.

Risk Group 4

Vaccinated individuals at risk of severe disease (anyone aged ≥ 65 years or anyone aged < 65 with clinical risk factors)

Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment. And to get through this pandemic at your healthiest, don’t miss these 35 Places You’re Most Likely to Catch COVID.