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

Last Updated: July 08, 2021

Table 2e. Characteristics of Antiviral Agents That Are Approved or Under Evaluation for Treatment of COVID-19
Dosing Regimens
The doses listed here are for approved indications or from reported experiences or clinical trials.
Adverse Events Monitoring Parameters Drug-Drug Interaction Potential Comments and Links to Clinical Trials

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 IVa 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 IVa on Day 1, then RDV 100 mg IV on Days 2–10

Suggested Dose in EUAb for Hospitalized Children

For Patients Weighing 3.5 kg to <40 kg:

  • RDV 5 mg/kg IVa 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 EUAb 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 ( 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