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
- 5 -
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