Table 2e. Characteristics of Antiviral Agents That Are Approved or Under Evaluation for the Treatment of COVID-19

The doses and indications listed below come from the FDA product information. Please see Therapeutic Management of Hospitalized Adults With COVID-19 for the Panel's recommendations on when to use RDV.

For Hospitalized Adults and Children (Aged =12 Years and Weighing =40 kg)

For Patients Who Are Not Mechanically Ventilated and/or on ECMO:

• RDV 200 mg IV^a on Day 1, then RDV 100 mg IV on Days 2–5
• For patients who do not show clinical improvement after 5 days of therapy, treatment may be extended to up to 10 days.

For Mechanically Ventilated Patients and/or Patients on ECMO:

• RDV 200 mg IV^a on Day 1, then RDV 100 mg IV on Days 2–10

Suggested Dose in EUA^b for Hospitalized Children

For Patients Weighing 3.5 kg to <40 kg:

• RDV 5 mg/kg IV^a on Day 1, then RDV 2.5 mg/kg IV once daily starting on Day 2
• For patients who are not mechanically ventilated and/or on ECMO, the duration is 5 days. If patients have not shown clinical improvement after 5 days, treatment may be extended to up to 10 days.
• For mechanically ventilated patients and/or patients on ECMO, the recommended treatment duration is 10 days.

For Patients Aged <12 Years and Weighing =40 kg:

• Same dose as for adults

• Nausea
• ALT and AST elevations
• Hypersensitivity
• Increases in prothrombin time
• Drug vehicle is SBECD, which has been associated with renal and liver toxicity. SBECD accumulation may occur in patients with moderate or severe renal impairment.
• Each 100 mg vial of RDV lyophilized powder contains 3 g of SBECD, and each 100 mg/20 mL vial of RDV solution contains 6 g of SBECD.
• Clinicians may consider preferentially using the lyophilized powder formulation (which contains less SBECD) in patients with renal impairment.

• Infusion reactions
• Renal function and hepatic function should be monitored before and during treatment as clinically indicated.
• In the FDA product information, RDV is not recommended when eGFR is <30 mL/min. See the Remdesivir section for a discussion on using RDV in people with renal insufficiency.
• RDV may need to be discontinued if ALT level increases to >10 times ULN and should be discontinued if there is an increase in ALT level and signs or symptoms of liver inflammation are observed.¹

• Clinical drug-drug interaction studies of RDV have not been conducted.
• In vitro, RDV is a substrate of CYP3A4, OATP1B1, and P-gp and an inhibitor of CYP3A4, OATP1B1, OATP1B3, and MATE1.¹
• Minimal to no reduction in RDV exposure is expected when RDV is coadministered with dexamethasone (Gilead Sciences, written communication, July 2020).
• CQ or HCQ may decrease the antiviral activity of RDV; coadministration of these drugs is not recommended.¹
• No significant interaction is expected between RDV and oseltamivir or baloxavir (Gilead Sciences, personal and written communications, August and September 2020).

• RDV should be administered in a hospital or a health care setting that can provide a similar level of care to an inpatient hospital.
• RDV is approved by the FDA for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged =12 years and weighing =40 kg).
• An EUA^b is available for hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing =3.5 kg.
• A list of clinical trials is available here: Remdesivir

• The dose most commonly used in clinical trials is IVM 0.2–0.6 mg/kg PO given as a single dose or as a once-daily dose for up to 5 days.

• Generally well tolerated
• Dizziness
• Pruritis
• GI effects (e.g., nausea, diarrhea)
• Neurological AEs have been reported when IVM has been used to treat parasitic diseases, but it is not clear whether these AEs were caused by IVM or the underlying conditions.

• Monitor for potential AEs.

• Minor CYP3A4 substrate
• P-gp substrate

• Generally given on an empty stomach with water; however, administering IVM with food increases its bioavailability.²
• A list of clinical trials is available here: Ivermectin

• Doses reported in COVID-19 studies range from NTZ 500 mg PO 3 times daily to 4 times daily.^3,4 Higher doses are being studied (ClinicalTrials.gov Identifier NCT04746183).
• Doses used for antiprotozoal indications range from NTZ 500 mg to 1 g PO twice daily.

• Generally well tolerated
• Abdominal pain
• Diarrhea
• Headache
• Nausea
• Vomiting
• Urine discoloration
• Ocular discoloration (rare)

• Monitor for potential AEs.

• Drug-drug interactions may occur if NTZ is administered concurrently with other highly plasma protein-bound drugs due to competition for binding sites.⁵
• If NTZ is coadministered with other highly protein-bound drugs with narrow therapeutic indices, monitor the patient for AEs.

• NTZ should be taken with food.
• The oral suspension is not bioequivalent to the tablet formulation.
• A list of clinical trials is available here: Nitazoxanide