Coronavirus Disease 2019 (COVID-19) Medication

Updated: Jan 24, 2022
  • Author: David J Cennimo, MD, FAAP, FACP, FIDSA, AAHIVS; Chief Editor: Michael Stuart Bronze, MD  more...
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Medication

Medication Summary

Remdesivir (Veklury) was the first drug approved by the FDA for treating the SARS-CoV-2 virus. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. [22]  The broad-spectrum antiviral is a nucleotide analog prodrug. Full approval was preceded by the US FDA issued an EUA (emergency use authorization) on May 1, 2020 to allow prescribing of remdesivir for severe COVID-19 (confirmed or suspected) in hospitalized adults and children prior to approval. [155]  Upon approval of remdesivir in adults and adolescents, the EUA was updated to maintain the ability for prescribers to treat pediatric patients weighing 3.5 kg to less than 40 kg or children younger than 12 years who weigh at least 3.5 kg. [23]   

The first vaccine to gain full FDA approval was mRNA-COVID-19 vaccine (Comirnaty; Pfizer) in August 2021. 

Investigational treatments include other antiviral agents, vaccines, immunomodulators, monoclonal antibodies, convalescent plasma, and antithrombotics. Several of the above therapies and vaccines have been granted emergency use authorization by the FDA.

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Vaccines

Class Summary

The FDA has granted emergency use authorization for the vaccines listed below.

COVID-19 vaccine, mRNA-Pfizer (Comirnaty)

August 23, 2021: Granted full approval by the FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 16 years and older. Administered IM as a 2-dose series 3 weeks apart.

May 10, 2021: Emergency use authorization (EUA) granted for adolescents aged 12-15 years. 

August 12, 2021: EUA granted for third dose for individuals aged 12 years and older who have undergone solid organ transplantation or have conditions with equivalent level of immunocompromise.

September 22, 2021: FDA revised the EUA to include a single booster dose for individuals aged 65 years and older, individuals aged 18 to 64 years at high risk for severe COVID-19, and those aged 18 to 64 years whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

COVID-19 vaccine, mRNA-Moderna (mRNA-1273)

December 18, 2020: Emergency use authorization (EUA) issued by FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥18 years. Administered IM as a 2-dose series 1 month apart. The vaccine was submitted mid-2021 to the FDA to review for full approval.  

COVID-19 vaccine, viral vector-Janssen (Ad26.COV2.S [Johnson & Johnson])

February 27, 2021: Emergency use authorization (EUA) issued by FDA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥18 years. Administered IM as a single dose. 

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Monoclonal Antibodies

Class Summary

Recombinant neutralizing human IgG monoclonal antibodies (mAb) exert their effect by binding to various sites on the SARS-CoV-2 spike protein. Owing to the increase in variants of concern (VOC) in the United States, monoclonal antibodies that have gained emergency use authorization are continually tested to evaluate activity against VOCs. Information, including allocation, for monoclonal antibody treatments for COVID-19 granted emergency use authorization is located at the United States HHS Preparedness and Response.

Casirivimab/imdevimab (REGEN-COV)

FDA granted EUA November 21, 2020. Casirivimab and imdevimab IV solution are each supplied in individual single-dose vials and are admixed in the same IV bag. May also be administered SC when an IV infusion is not feasible. In July 2021, the EUA updated to include use as postexposure prophylaxis in additional to treatment for individuals aged 12 years and older (weighing at least 40 kg) at high risk of progression to severe COVID-19, including hospitalization or death, and are not fully vaccinated or are not expected to mount an adequate immune response. 

Sotrovimab

FDA granted EUA May 26, 2021. Binds to conserved epitope of the spiked protein of SARS-CoV-1 and SARS-CoV-2, thereby indicating unlikelihood of mutational escape. The EUA was granted for treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients aged 12 years and older (weighing at least 40 kg) who test positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death. 

Bamlanivimab and etesevimab

EUA for treatment of treatment or postexposure prophylaxis of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progressing to severe COVID-19, including hospitalization or death. Etesevimab and bamlanivimab are prepared by admixing each dose within the same IV bag. Etesevimab and bamlanivimab bind to different but overlapping epitopes in the receptor-binding domain of the S-protein. In clinical trials, bamlanivimab and etesevimab administered together resulted in fewer treatment-emergent variants relative to bamlanivimab administered alone. 

Tixagevimab and cilgavimab (Evusheld)

EUA granted for preexposure prophylaxis of COVID-19 individuals aged 12 years and older (weighing at least 40 kg) who are moderately-to-severely immunocompromised owing to a medical condition or medications/treatment and may no mount an adequate immune response to COVID-19 vaccination, or have a history of severe adverse reactions to a COVID-19 vaccine and/or component(s). Tixagevimab and cilgavimab are long-acting recombinant human IgG1kappa monoclonal antibodies. The antibodies bind to the SARS-CoV-2 virus spike protein, thereby blocking its interaction with the human ACE2 receptor, which is required for virus attachment. 

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Corticosteroids

Class Summary

NIH guidelines for COVID-19 recommends use of dexamethasone to reduce mortality in hospitalized patients who are mechanically ventilated or those requiring supplemental oxygen without mechanical ventilation. [370]  These recommendations are based on results of the RECOVERY trial. [24]  

If dexamethasone is unavailable, use alternant glucocorticoids (eg, prednisone, methylprednisolone, or hydrocortisone). [370]  

Dexamethasone

Decreases inflammation by suppressing migration of polymorphonuclear leukocytes (PMNs) and reducing capillary permeability; stabilizes cell and lysosomal membranes.

Prednisone (Deltasone)

Consider use if dexamethasone is unavailable. Available as oral formulation. 

Methylprednisolone (A-Methapred, DepoMedrol, Medrol)

Consider use if dexamethasone is unavailable. Available as IV formulation.

Hydrocortisone

Consider use if dexamethasone is unavailable. Available as oral or IV formulations.

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Antiviral Agents

Class Summary

Remdesivir was the first antiviral drug approved by the FDA for COVID-19. Two oral antivirals were granted EUAs in December 2021. 

Remdesivir (Veklury)

Adenosine nucleotide prodrug that distributes into cells, where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication. It gained full FDA approval for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. It is also approved as a 3 consecutive day for outpatients aged 12 years and older (weighing at least 40 kg) with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death. 

Also, an EUA has been granted for hospitalized and nonhospitalized pediatric patients weighing 3.5 kg to less than 40 kg or children younger than 12 years who weigh at least 3.5 kg. 

Nirmatrelvir/ritonavir (Paxlovid)

Oral nirmatrelvir is an inhibitor of SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nsp5 protease. Inhibition of SARS-CoV-2 Mpro renders it incapable of processing polyprotein precursors, and thereby, preventing viral replication. Nirmatrelvir is boosted with low-dose ritonavir that slows nirmatrelvir metabolism via CYP3A4 inhibition, which results in higher systemic exposure. The EUA is for treatment of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 years and older who weigh at least 40 kg who test positive for SARS-CoV-2 virus, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Molnupiravir

Orally bioavailable prodrug of nucleoside analogue beta-D-N4-hydroxycytidine (NHC), which distributes into cells where NHC is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). Incorporation of NHC-TP into SARS-CoV-2 RNA by viral RNA polymerase results in an accumulation of errors in the viral genome, leading to inhibition of replication. The EUA is for treatment of mild-to-moderate COVID-19 in adults aged 18 years and older who test positive for SARS-CoV-2 virus, and are at high risk for progression to severe COVID-19, including hospitalization or death.

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Immunomodulators

Class Summary

Immunomodulators plus other treatment modalities (eg, remdesivir, glucocorticoids) may be considered for hospitalized patients with severe COVID-19 to blunt the hyperinflammation caused by cytokine release.

Tocilizumab (Actemra)

June 24, 2021: Emergency use authorization (EUA) issued by the FDA for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients (aged >2 years) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO.

Baricitinib (Olumiant)

November 19, 2020: Emergency use authorization (EUA) issued by the FDA for use, in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients aged ≥2 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA was revised in July 2021 to allow use with or without remdesivir.

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