Table 3.

Summary of therapeutic agents granted EA and/or EUA for the management of COVID-19^a

Treatments with Expanded Access	Sponsor	Dosing regimen	Route of administration	Mode of action	Common adverse events	Contraindications (US labeling)	Major drug interactions	Use in specific populations
Remdesivir	Gilead Sciences	EUA for hospitalized adults and children weighing 40 kg or more: Loading dose of 200 mg by IV infusion on day 1, followed by a maintenance dose of 100 mg by IV infusion once daily from day 2 for 5–10 days. EUA for hospitalized children weighing 3.5 to less than 40 kg (lyophilized powder formulation only): Loading dose of 5 mg/kg by IV infusion on day 1, followed by maintenance doses of 2.5 mg/kg by IV infusion once daily from day 2 for 5–10 days.	IV	RNA replicase inhibitor	Infusion-related reaction, increased transaminases, nausea, headache, rash	Known hypersensitivity to any ingredient of remdesivir	Substrate for CYP2C8, CYP2D6, CYP3A4, OATP1B1, P-gp. Inhibitor of CYP3A4, OATP1B1, OATP1B3, BSEP, MRP4, NTCP. Coadministration of remdesivir and hydroxychloroquine or chloroquine may result in reduced antiviral activity of remdesivir.	Use during pregnancy and breastfeeding only if potential benefits outweigh potential risks. Use appropriate caution and monitoring in elderly. Not recommended in adults and pediatrics with eGFR <30 mL/min. Use in patients with hepatic impairment only if potential benefits outweigh potential risks.
Convalescent plasma	Collaboration between industry, academic and government partners, Mayo Clinic, Lead Institution	Initiate therapy with one unit (i.e. 200 mL) of COVID-19 convalescent plasma. One or two infusions.	IV	Neutralizing antibodies provide short-term passive immunity	Inadvertent transmission of infectious agents, allergic reactions, thrombotic complications, transfusion-associated circulatory overload, transfusion-related acute lung injury	Allergy to human plasma, sodium citrate, methylene blue IgA-deficient patients with antibodies to IgA and a history of hypersensitivity	None	Not recommended in patients with heart failure, chronic kidney failure in the dialysis phase, and organ transplant
Ruxolitinib	Incyte Corporation	5 mg bid	PO	JAK/JAK2 inhibitor	Thrombocytopenia, neutropenia, anemia, infections, edema, headache, dizziness	None	CYP3A4 substrate. Serum roxulitinib levels may increase when used with CYP3A4 inhibitors (i.e. ritonavir)	Use in pregnant and lactating women is not recommended. May require starting dose reduction in hepatic and renal impairment.
Fresenius Propoven 2% Emulsion	Fresenius Kabi USA, LLC.	0.3-0.4 mg/kg/hr	Infusion only	Activation of GABA receptors	Hypotension, respiratory depression, apnea, increased triglycerides, myoclonus	Hypersensitivity to peanut or soy	CYP3A4 inhibitor. Metabolized by CYP2B6. Fentanyl, cyclosporine, valproate	Caution should be taken when treating patients with mitochondrial disease, epilepsy, and disorders of fat metabolism. Do not use in pregnant women unless no other medications to maintain sedation.
Hydroxychloroquine (REVOKED)	Supplied from Strategic National Stockpile	400 mg bid on day 1, then 200 mg bid on days 2–5; 400 mg od for 5 days; 200 mg tid for 10 days; 100–200 mg bid for 5–14 days	PO	Anti-inflammatory and immunomodulatory effects	QTc prolongation, abdominal pain, decreased appetite, diarrhea, nausea, vomiting, hemolysis in G-6-PD deficiency, hypoglycemia, retinopathy, nervous system disorders, psychiatric disorders	Known hypersensitivity to hydroxychloroquine, 4-aminoquinoline derivatives, or any component of the formulation	CYP2D6, CYP2C8, CYP3A4, CYP3A5	Caution should be exercised when administering to pregnant and nursing mothers
Bamlanivimab	Eli Lilly	700 mg as single infusion over 60 mins	IV	Neutralizing IgG1 monoclonal antibody	Dizziness, headache, pruritis, immediate nonserious hypersensitivity	None	None	Use during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus. Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production.
Baricitinib	Eli Lilly	4 mg for 14 days	PO	JAK/JAK2 inhibitor	Upper respiratory tract infections, nausea, herpes simplex, herpes zoster	None	Substrate of BCRP/ABCG2, CYP3A4, OAT1/3, P-gp/ABCB1. Avoid use with strong OAT3 inhibitors	Not studied in pregnant or lactating women with COVID-19. Dose adjustment for patients with eGFR <60. No dose adjustment required for patient with mild or moderate hepatic impairment.
Casirivimab and Imdevimab	Regeneron	1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single infusion	IV	Combination of two recombinant neutralizing IgG1 monoclonal antibodies	Anaphylaxis and infusion-related reactions, fever, chills, hives, itching, flushing	None	None	No dose adjustment is recommended in pregnant or lactating women. Not recommended for pediatric patients weighing less than 40 kg or those less than 12 years of age.

^aAbbreviations: bid, twice daily; COVID-19, coronavirus disease 2019; CYP, cytochrome P450; eGFR, estimated glomerular filtration rate; EUA, emergency use authorization; G-6-PD, glucose-6-phosphate dehydrogenase; IgA, immunoglobulin A; IV, intravenous; JAK, Janus kinase; OAT, organic anion transporter; od, once daily; P-gp, P-glycoprotein; PO, oral; tid, three times daily.