COVID-19 Omicron Approved Treatments

Treatments for COVID-19 Omicron Variant

FDA or EUA approved

(Current as of 2/13/2022)

Paxlovid

(EUA 12/21/21)

Paxlovid received Emergency Use Authorization (EUA) in late December 2021

• Paxlovid is a combination of two medications.
• Nirmatrelvir tablets and Ritonavir tablets, co-packaged for oral use.
• EUA approved for the treatment of mild-to-moderate coronavirus disease (COVID-19).
• Used in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing.
• Prescribed for patients who are at high risk for progression to severe COVID-19, including hospitalization or death.
• Paxlovid should be prescribed after confirmed diagnosis and within five days of becoming symptomatic.

 How it Works

• Nirmatrelvir inhibits a SARS-CoV-2 protein to stop the virus from replicating.
• Ritonavir slows down Nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.

Treatment Course

• Paxlovid is administered as three tablets (two tablets of Nirmatrelvir and one tablet of Ritonavir).
• Tablets are to be taken together orally twice-daily for five days, for a total of 30 tablets.

Efficacy

• Paxlovid significantly reduced the proportion of people with COVID-19-related-hospitalization or death from any cause by 88% compared with placebo. 
• In this analysis, 1,039 patients received Paxlovid, and 1,046 patients received a placebo.
• 0.8% who received Paxlovid were hospitalized, or died, during 28 days of follow-up compared to 6% of the patients who received placebo. 

Molnupiravir

• Similar in indications, uses, and mechanism of action as Paxlovid.
• The big difference is in the lesser efficacy, with a 33% reduction of risk from death and hospitalization, not the 88% seen with Paxlovid.
• The advantage is that Molnupiravir is more available at the time of this writing.

Remdesivir

(FDA approved 1/24/2022)

Remesivir received FDA approval for outpatients 1/24/2022

• It's for patients at high risk of hospitalization and death.
• FDA approved use in those 12 years and older at risk for disease progression.
• Risk factors include age over 60, hypertension, cardiovascular, or cerebrovascular disease, diabetes mellitus, obesity (a body-mass-index of greater than 30), immune-compromised, chronic kidney disease, chronic liver disease, chronic lung disease, current cancer, or sickle-cell disease.
• Confirmed + Covid testing.
• Treatment to begin within seven days of symptom onset.

How it Works

• Remdesivir targets the highly conserved viral RNA-dependent RNA polymerase, which blocks the virus from copying itself.
• Remdesivir is likely to maintain efficacy against emerging SARS-CoV-2 variants of concern.
• In vitro testing has shown that all variants of concern remain susceptible to remdesivir.

Treatment Course

• Given as daily infusion for three days.
• Typically given at infusion centers or hospitals.

Efficacy

• Three-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo. 

Monoclonal Antibody infusions 

• There have been three approved monoclonal antibody infusions however two of the three have lost efficacy against Omicron variant.
• Sotrovimab is the remaining one of the original three that is effective against Omicron variant.

Bebtelovimab received EUA on 2/11/2022

(Both monoclonal antibodies are similar, thus will be put in the same category and will be referred to generically as monoclonal antibody in the rest of this text)  

• The EUA for monoclonal antibodies is for the treatment of mild to moderate COVID-19.
• Adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds).
• Positive COVID-19 test.
• High risk for progression to severe COVID-19, including hospitalization or death.
• Onset of symptoms less than 10 days prior to administration of monoclonal antibody infusion.

How it works

• Monoclonal antibodies work by binding to the spike protein of the virus that causes COVID-19.

Efficacy

• This is a bit of a moving target with different Monoclonal antibody formulations and emergence of variants. However, most trials show between 82-85% risk reduction of death and hospitalization at 28 days after onset of illness. 

Ongoing Clinical Trial

Duke University ACTIV-6

A nationwide study was completed involving 2500 patients in 26 states. The three drugs were chosen for the study because they’ve shown some promise in treating COVID-19, through earlier studies and by what’s known about how they work in the body. Fluticasone, for example, is a steroid that reduces inflammation in the lungs that can cause breathing problems, which is also a primary symptom of COVID-19.

• Ivermectin
• Fluvoxamine
• Fluticasone

There are numerous other studies in United States and around the world that are studying Ivermectin and other agents. To date, regarding Ivermectin, there has been no proven benefit. This study should have the power, meaning large enough, prospective, and with placebo controls, that will put issue to rest one way or the other.

The best approach to prevent complications from COVID-19 is vaccination. Now, we have some therapeutics that are studied, approved, and becoming available. But, unfortunately, at the time of this writing, all of the above treatments are very difficult to obtain and use within the therapeutic-treatment window.