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      News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point
      Drugs & Diseases > Infectious Diseases

      Coronavirus Disease 2019 (COVID-19) Medication

      Updated: Apr 06, 2023
      • Author: David J Cennimo, MD, FAAP, FACP, FIDSA, AAHIVS; Chief Editor: Michael Stuart Bronze, MD  more...
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      Medication

      Medication Summary

      Remdesivir (an antiviral agent), baricitinib (an immunomodulatory drug), and 2 mRNA vaccines have gained full FDA approval for prevention and treatment of COVID-19 disease. 

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

      As of January 2023, there are no active EUAs for SARS-CoV-2-directed monoclonal antibodies owing to current circulating variants that are non-susceptible. 

      Treatment does not preclude isolation and masking for those who test positive for SARS-CoV-2. 

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      Vaccines

      Class Summary

      The FDA has granted either full approval and/or emergency use authorization for the vaccines listed below.

      COVID-19 vaccine, mRNA-Pfizer (Comirnaty)

      Indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 6 months and older. 

      COVID-19 vaccine, mRNA-Moderna (Spikevax)

      Indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 6 months and older. 

      COVID-19 vaccine, adjuvanted-Novavax (NVX-CoV2373)

      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 12 years and older.

      COVID-19 bivalent vaccine, mRNA-Pfizer (BNT162b2 OMI)

      Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated as a single booster dose for adolescents aged 5 years and older.

      COVID-19 bivalent vaccine, mRNA-Moderna (MRNA-1273.222)

      Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated as a single booster dose for adolescents aged 5 years and older. 

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

      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 and older. 

      The EUA was revised in May 2022 to emphasize limited use (ie, for individuals whom other authorized/approved COVID-19 vaccines are not accessible or clinically appropriate, or the individual elects the AD26.COV2.S vaccine and would otherwise not receive a vaccine).

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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 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 and are at high risk for progression to severe COVID-19, including hospitalization or death.

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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. [317]  These recommendations are based on results of the RECOVERY trial. [25]  

      If dexamethasone is unavailable, use alternant glucocorticoids (eg, prednisone, methylprednisolone, or hydrocortisone). [317]  

      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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      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.

      Baricitinib (Olumiant)

      Baricitinib is the first immunotherapy to gain full FDA approval in May 2022 for treatment of hospitalized adults who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). An Emergency use authorization (EUA) was issued by the FDA for baricitinib on November 19, 2020, and remains in place for children aged 2-17 years following approval for adults. 

      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.

      Anakinra (Kineret)

      November 8, 2022 : Emergency use authorization (EUA) granted for treatment of COVID-19 pneumonia in hospitalized adults on supplemental oxygen (low- or high-flow) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).

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      Complement Inhibitors

      Class Summary

      Vilobelimab is a chimeric human/mouse immunoglobulin G4 (IgG4) antibody consisting of mouse anti-human complement factor 5a (C5a) monoclonal binding sites. C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.

      Vilobelimab (Gohibic)

      April 4, 2023: Emergency use authorization (EUA) granted by the FDA for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults when initiated within 48 hr of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). 

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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. As of January 2023, there are no active EUAs for SARS-CoV-2 directed monoclonal antibodies owing to current circulating variants that are non-susceptible. 

      Tixagevimab and cilgavimab (Evusheld)

      January 26, 2023: Not currently authorized in any US region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible.

      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. 

      Bebtelovimab

      November 30, 2022: Not currently authorized in any US region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible. 

      EUA granted February 11, 2022. It binds to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. 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.

      Sotrovimab

      March/April 2022: Distribution paused owing to low efficacy against omicron BA.2 VOC.

      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. 

      Casirivimab/imdevimab (REGEN-COV)

      December 2021: Distribution paused owing to low efficacy against omicron VOC.

      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. 

      Bamlanivimab and etesevimab

      December 2021: Distribution paused owing to low efficacy against omicron VOC.

      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. 

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