Treatments Considered for COVID-19 (Updated September 24 ...

Treatments Considered for COVID-19 (Updated April 1, 2022)

The table below lists pertinent evidence on the clinical effectiveness and safety of some drugs and other therapies being considered for COVID-19. Most authorities recommend use of these drugs only in the setting of a clinical trial or when access via clinical trial is not available. Inclusion in this table is not a recommendation for use for treatment of COVID-19. The information on these drugs is evolving rapidly and The Medical Letter does not warrant that all the material in this publication is current, accurate, or complete in every respect.

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March 30, 2022/April 1, 2022

RECENT TABLE UPDATES

Monoclonal Antibodies ? FDA restricts use of sotrovimab in areas where the BA.2 variant causes >50% of COVID-19 cases

Ivermectin ? Randomized, double-blind, placebo-controlled trial in high-risk outpatients found no benefit of ivermectin use

mRNA Vaccines ?

FDA authorizes second booster doses of the Pfizer/BioNTech and Moderna vaccines for persons 50 years old and certain immunocompromised persons

February 28, 2022

Monoclonal Antibodies ? FDA amends EUA for tixagevimab and cilgavimab to increase the recommended dose of each drug from 150 mg to 300 mg

mRNA Vaccines ?

CDC issues new guidance allowing for an interval of up to 8 weeks between the 1st and 2nd primary doses of an mRNA vaccine in certain patients 12-64 years old, especially males 12-

39 years old

February 17, 2022

Monoclonal Antibodies ? FDA issues EUA for bebtelovimab for IV treatment of mild to moderate COVID-19 in patients 12 years old who weigh 40 kg and are at high risk of progressing to severe disease,

including hospitalization and death, and for whom alternative treatment options are unavailable or inappropriate; bebtelovimab is active against the Omicron variant of SARS-CoV-2

Adenovirus-Vectored Vaccines ? CDC recommends immunocompromised persons who received the J&J vaccine for their primary series should receive 1 dose of Pfizer/BioNTech or Moderna (100 mcg) vaccine 4

weeks after initial J&J vaccine dose; a booster dose with an mRNA vaccine (Pfizer/BioNTech or Moderna [50 mcg]) should be given 2 months after the additional mRNA dose

mRNA Vaccines ? CDC recommends immunocompromised persons can receive a booster dose 3 months after completion of a 3-dose mRNA vaccine primary series

Indicates change in selected section from last version in Table of Contents on next page

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Table of Contents

INVESTIGATIONAL DRUGS .......................................................... - 5 -

Antivirals........................................................................................ - 5 -

FAVIPIRAVIR REMDESIVIR MOLNUPIRAVIR Nirmatrelvir (PF-07321332)/Ritonavir

Convalescent Plasma .................................................................. - 24 Intravenous Immune Globulin (IVIG............................................. - 34 Monoclonal Antibodies................................................................. - 36 -

LY-CoV555 (bamlanivimab) and LY-CoV016 (etesevimab) REGN-COV-2 (REGEN-COV) CASIRIVIMAB (REGN10933) and IMDEVIMAB (REGN10987) AZD7442 Tixagevimab (AZD8895) and Cilgavimab (AZD1061) VIR-7831 (Sotrovimab) LY-CoV1404 (Bebtelovimab)

GM-CSF Inhibitor......................................................................... - 60 -

Lenzilumab

Glutathione and N-acetylcysteine ................................................ - 61 Stem Cell Therapy....................................................................... - 62 -

MESENCHYMAL STEM CELL THERAPY

Vasoactive Intestinal Peptide....................................................... - 64 -

AVIPTADIL

Oleandrin..................................................................................... - 65 -

OLEANDRIN

REPURPOSED DRUGS ................................................................ - 66 -

Corticosteroids (systemic) ........................................................... - 66 Inhaled Corticosteroids ................................................................ - 73 IL-6 Inhibitors............................................................................... - 76 -

SARILUMAB

TOCILIZUMAB

IL-1 Receptor Antagonists ............................................................- 91 -

ANAKINRA CANAKINUMAB

Bruton Tyrosine Kinase (BTK) Inhibitor ........................................- 94 -

ACALABRUTINIB

Janus Kinase (JAK) Inhibitors.......................................................- 95 -

BARICITINIB RUXOLITINIB TOFACITINIB

TNF Inhibitors.............................................................................- 100 -

TNF INHIBITORS

Anti-CD6 Monoclonal Antibody...................................................- 101 -

ITOLIZUMAB

C5 Complement Inhibitor............................................................- 102 -

RAVULIZUMAB

Antimalarials...............................................................................- 103 -

CHLOROQUINE HYDROXYCHLOROQUINE

Macrolide Antibiotic ....................................................................- 123 -

AZITHROMYCIN

HIV Protease Inhibitors...............................................................- 131 -

ATAZANAVIR DARUNAVIR/COBICISTAT LOPINAVIR/RITONAVIR

Interferons and Ribavirin ............................................................- 135 -

INTERFERON BETA-1B INTERFERON BETA-1A ? INHALED (SNG001) INTERFERON ALPHA-2b (inhaled)

Antiparasitic................................................................................- 139 -

IVERMECTIN

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Bradykinin Inhibitor .................................................................... - 150 -

ICATIBANT

Colchicine.................................................................................. - 151 Dipeptidyl Peptidase-4 (DPP-4) Inhibitors.................................. - 154 Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors .............. - 155 H2-Receptor Antagonists (H2RAs) ............................................ - 157 -

FAMOTIDINE

Selective Serotonin Reuptake Inhibitor (SSRI) .......................... - 160 -

FLUVOXAMINE

Progesterone ............................................................................. - 163 -

Progesterone

Statins ....................................................................................... - 164 -

Atorvastatin

Vitamins .................................................................................... - 165 -

ASCORBIC ACID ZINC VITAMIN D THIAMINE

Aspirin (ASA) ............................................................................. - 175 -

ASPIRIN

Nasal Saline Irrigation ............................................................... - 176 Melatonin................................................................................... - 177 Benzalkonium Chloride.............................................................. - 178 Povidone-Iodine ........................................................................ - 179 VENOUS THROMBOEMBOLISM (VTE) PROPHYLAXIS.................- 180 -

Unfractionated Heparin (UFH) ................................................... - 180 -

Heparin

Low Molecular Weight Heparin (LMWH) .................................... - 180 -

Enoxaparin Dalteparin

Factor Xa Inhibitor ......................................................................- 180 -

Fondaparinux

CONCOMITANT DRUGS ........................................................... - 182 -

Renin-Angiotensin System (RAS) Inhibitors ...............................- 182 -

ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS ANGIOTENSIN RECEPTOR BLOCKERS (ARBS)

Nonsteroidal Anti-inflammatory Drugs (NSAIDs) ........................- 191 Proton Pump Inhibitors (PPIs) ....................................................- 192 Biguanide ...................................................................................- 194 -

METFORMIN

VACCINES ............................................................................... - 196 -

Adenovirus-Vectored Vaccines...................................................- 196 -

CHIMPANZEE ADENOVIRUS-VECTORED COVID-19 (ChAdOx1 nCoV-19) VACCINE (AZD1222) RECOMBINANT ADENOVIRUS TYPE-5 (Ad5)-VECTORED COVID-19 VACCINE ADENOVIRUS SEROTYPE 26 (Ad26) VECTOR-BASED COVID-19 VACCINE (Ad26.COV2.S)(JNJ-78436735)

mRNA Vaccines .........................................................................- 215 -

mRNA-1273 BNT162b1 and BNT162b2

Adjuvanted Recombinant Nanoparticle Vaccine .........................- 282 -

NVX-CoV2373

Inactivated Vaccine ....................................................................- 286 -

Whole-Virus Inactivated SARS-CoV-2 Vaccine (WIV04 strain) Whole-Virus Inactivated SARS-CoV-2 Vaccine (WIV04 strain)

DNA Vaccine..............................................................................- 288 -

INO-4800

Adjuvanted Recombinant Protein-Based Vaccine.......................- 288 -

Adjuvanted Recombinant Protein-Based Vaccine

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INVESTIGATIONAL DRUGS

DRUG AND DOSAGE Antivirals

EFFICACY

ADVERSE EFFECTS/INTERACTIONS

FAVIPIRAVIR ? AVIGAN (FUJIFILM)

(updated 9/24/2020)

Dosage: 1600 mg PO bid on day 1, then 600

mg bid on days 2-71

Some suggest a dosage of 24003000 mg bid on day 1, then 12001800 mg bid2

Q Cai et al. 20201 Population: hospitalized, nonsevere (n=80) Design: open-label, nonrandomized Results: shorter viral clearance time (4 vs 11 days) and improvements in chest CT (91.4% vs 62.2%) with favipiravir vs lopinavir/ritonavir; results should be interpreted with caution1

Chen et al. 20203 Population: hospitalized patients (n=236) Design: randomized, open-label favipiravir vs arbidol (an influenza

drug not available in the US); both in addition to standard therapy Results: clinical recovery rate at day 7 was similar for favipiravir and arbidol (51.67% vs 61.21%; p=0.1396) in patients with moderate disease, clinical recovery rates were higher with favipiravir than arbidol (71.43% vs 55.86%; p=0.0199) Limitations: not peer-reviewed

Adverse Effects: Elevated LFTs, diarrhea, nausea,

vomiting, chest pain and elevated serum uric acid

Drug Interactions: May increase serum concentrations of

some drugs such as acetaminophen, penicillins, tazobactam, repaglinide, pioglitazone and rosiglitazone, oseltamivir, theophylline, and progestins

Ivashchenko et al. Clin Infect Dis 20205 (added 8/9/2020)

COMMENTS

Not FDA-approved and not available yet in the US

Approved in other countries for treatment of influenza

Russian Ministry of Health granted conditional marketing authorization for favipiravir (Avifavir) (added 8/9/2020)

Viral RNA polymerase inhibitor

Limited data available to date; may be less effective for patients with more severe disease

Randomized controlled trial of favipiravir alone and in combination with tocilizumab ongoing in China

Pregnancy: Contraindicated for use in pregnant

women4

Teratogenic effects in animal studies

Men taking the drug should avoid intercourse with pregnant women during treatment and for at least 7 days after the last dose

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