Effects of remdesivir on SARS-CoV-2 viral dynamics and mortality in viraemic patients hospitalized for COVID-19

Hagman et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkad295

Sep 2023

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Retrospective 318 hospitalized COVID-19 patients in Sweden, showing improvements in viral clearance but no improvement for mortality with remdesivir treatment.

Gérard, Zhou, Wu, Kamo, Choi, Kim show significantly increased risk of acute kidney injury with remdesivir.

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risk of death, no change, HR 1.00, p = 0.97, treatment 105, control 213, adjusted per study, multivariable, day 60.

risk of death, no change, HR 1.00, p = 0.99, treatment 105, control 213, adjusted per study, multivariable, day 28.

risk of death, 20.0% lower, HR 0.80, p = 0.74, treatment 105, control 213, adjusted per study, multivariable, day 7.

risk of progression, 40.0% higher, OR 1.40, p = 0.31, treatment 105, control 213, adjusted per study, multivariable, Table S7, RR approximated with OR.

risk of no viral clearance, 28.6% lower, HR 0.71, p = 0.11, treatment 105, control 213, adjusted per study, inverted to make HR<1 favor treatment, multivariable.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. Gérard et al., Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database, Clinical Pharmacology & Therapeutics, doi:10.1002/cpt.2145.wiley.com, doi.org.

2. Zhou et al., Acute Kidney Injury and Drugs Prescribed for COVID-19 in Diabetes Patients: A Real-World Disproportionality Analysis, Frontiers in Pharmacology, doi:10.3389/fphar.2022.833679.frontiersin.org, doi.org.

3. Wu et al., Acute Kidney Injury Associated With Remdesivir: A Comprehensive Pharmacovigilance Analysis of COVID-19 Reports in FAERS, Frontiers in Pharmacology, doi:10.3389/fphar.2022.692828.frontiersin.org, doi.org.

4. Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.iiarjournals.org, doi.org.

5. Choi et al., Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study, The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00353-0.sciencedirect.com, doi.org.

6. Kim et al., Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study, Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043.wiley.com, doi.org.

Hagman et al., 26 Sep 2023, retrospective, Sweden, peer-reviewed, 9 authors, average treatment delay 6.0 days.

This Paper Remdesivir All

Effects of remdesivir on SARS-CoV-2 viral dynamics and mortality in viraemic patients hospitalized for COVID-19

Karl Hagman, Magnus Hedenstierna, Jacob Widaeus, Emelie Arvidsson, Berit Hammas, Lena Grillner, Jan Jakobsson, Patrik Gille-Johnson, Johan Ursing

doi:10.1093/jac/dkad295/7283037

Background: Studies on the antiviral effects of remdesivir have shown conflicting results. SARS-CoV-2 viraemia could identify patients in whom antiviral treatment may be particularly beneficial. Objectives: To investigate antiviral effects and clinical outcomes of remdesivir treatment in viraemic patients. Methods: Viraemic patients hospitalized for COVID-19 with ratio of arterial oxygen partial pressure to fractional inspired oxygen of ≤300, symptom duration ≤10 days, and estimated glomerular filtration rate ≥30 mL/min were included in a cohort. The rate of serum viral clearance and serum viral load decline, 60 day mortality and in-hospital outcomes were estimated. A subgroup analysis including patients with symptom duration ≤7 days was performed. Results: A total of 318 viraemic patients were included. Thirty-three percent (105/318) received remdesivir. The rate of serum viral clearance [subhazard risk ratio (SHR) 1.4 (95% CI 0.9-2.0), P = 0.11] and serum viral load decline (P = 0.11) were not significantly different between remdesivir-treated patients and controls. However, the rate of serum viral clearance was non-significantly higher [SHR 1.6 (95% CI 1.0-2.7), P = 0.051] and the viral load decline was faster (P = 0.03) in remdesivir-treated patients with symptom duration ≤7 days at admission. The 60 day mortality [HR 1.0 (95% CI 0.6-1.8), P = 0.97] and adverse in-hospital outcomes [OR 1.4 (95% CI 0.8-2.4), P = 0.31] were not significantly different between remdesivir-treated patients and controls. Conclusions: Remdesivir treatment did not significantly change the duration of SARS-CoV-2 viraemia, decline of serum viral load, 60 day mortality or in-hospital adverse outcomes in patients with ≤10 days of symptoms at admission. Remdesivir appeared to reduce the duration of viraemia in a subgroup of patients with ≤7 days of symptoms at admission.

Ethics The Swedish Ethical Review Authority approved of the study (registration numbers 2020-01770 and 2020-06337). Informed consent was waived. Author contributions Conceptualization: K.H., M.H., P.G.-J., J.U. Methodology: K.H., M.H., J.J., J.U. Investigation: K.H., J.W., M.H., E.A., B.H., L.G., J.U. Data curation: K.H., B.H., L.G., J.U. Formal analysis: K.H., J.U. Writing-original draft: K.H., J.U. Writing-review and editing: K.H., J.W., M.H., E.A., B.H., L.G., J.J., P.G.-J., J.U. Visualization: K.H., J.U. Supplementary data Figure S1 and Tables S1 to S8 are available as Supplementary data at JAC Online.

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{ 'indexed': {'date-parts': [[2023, 9, 28]], 'date-time': '2023-09-28T12:45:24Z', 'timestamp': 1695905124891}, 'reference-count': 34, 'publisher': 'Oxford University Press (OUP)', 'license': [ { 'start': { 'date-parts': [[2023, 9, 26]], 'date-time': '2023-09-26T00:00:00Z', 'timestamp': 1695686400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by-nc/4.0/'}], 'funder': [ { 'DOI': '10.13039/501100004722', 'name': 'Lars Hierta Memorial Foundation', 'doi-asserted-by': 'publisher', 'award': ['FO2017-0482']}, { 'DOI': '10.13039/501100005689', 'name': 'Gothenburg Society of Medicine', 'doi-asserted-by': 'publisher', 'award': ['GLS-972295']}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': 'Abstract\n' ' \n' ' Background\n' ' Studies on the antiviral effects of remdesivir have shown ' 'conflicting results. SARS-CoV-2 viraemia could identify patients in whom antiviral treatment ' 'may be particularly beneficial.\n' ' \n' ' \n' ' Objectives\n' ' To investigate antiviral effects and clinical outcomes of ' 'remdesivir treatment in viraemic patients.\n' ' \n' ' \n' ' Methods\n' ' Viraemic patients hospitalized for COVID-19 with ratio of arterial ' 'oxygen partial pressure to fractional inspired oxygen of ≤300, symptom duration ≤10\u2005' 'days, and estimated glomerular filtration rate ≥30\u2005mL/min were included in a cohort. The ' 'rate of serum viral clearance and serum viral load decline, 60\u2005day mortality and ' 'in-hospital outcomes were estimated. A subgroup analysis including patients with symptom ' 'duration ≤7\u2005days was performed.\n' ' \n' ' \n' ' Results\n' ' A total of 318 viraemic patients were included. Thirty-three ' 'percent (105/318) received remdesivir. The rate of serum viral clearance [subhazard risk ' 'ratio (SHR) 1.4 (95% CI 0.9–2.0), P\u200a=\u200a0.11] and serum viral load decline (P\u200a' '=\u200a0.11) were not significantly different between remdesivir-treated patients and ' 'controls. However, the rate of serum viral clearance was non-significantly higher [SHR 1.6 ' '(95% CI 1.0–2.7), P\u200a=\u200a0.051] and the viral load decline was faster (P\u200a=\u200a' '0.03) in remdesivir-treated patients with symptom duration ≤7\u2005days at admission. The ' '60\u2005day mortality [HR 1.0 (95% CI 0.6–1.8), P\u200a=\u200a0.97] and adverse in-hospital ' 'outcomes [OR 1.4 (95% CI 0.8–2.4), P\u200a=\u200a0.31] were not significantly different ' 'between remdesivir-treated patients and controls.\n' ' \n' ' \n' ' Conclusions\n' ' Remdesivir treatment did not significantly change the duration of ' 'SARS-CoV-2 viraemia, decline of serum viral load, 60\u2005day mortality or in-hospital ' 'adverse outcomes in patients with ≤10\u2005days of symptoms at admission. 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'2023092721025247600_dkad295-B20', 'doi-asserted-by': 'crossref', 'first-page': '115595', 'DOI': '10.1016/j.diagmicrobio.2021.115595', 'article-title': 'Duration of SARS-CoV-2 viremia and its correlation to mortality and ' 'inflammatory parameters in patients hospitalized for COVID-19: a cohort ' 'study', 'volume': '102', 'author': 'Hagman', 'year': '2022', 'journal-title': 'Diagn Microbiol Infect Dis'}, { 'key': '2023092721025247600_dkad295-B21', 'doi-asserted-by': 'crossref', 'first-page': 'e148635', 'DOI': '10.1172/JCI148635', 'article-title': 'SARS-CoV-2 viremia is associated with distinct proteomic pathways and ' 'predicts COVID-19 outcomes', 'volume': '131', 'author': 'Li', 'year': '2021', 'journal-title': 'J Clin Invest'}, { 'key': '2023092721025247600_dkad295-B22', 'doi-asserted-by': 'crossref', 'first-page': '693', 'DOI': '10.1056/NEJMoa2021436', 'article-title': 'Dexamethasone in hospitalized patients with Covid-19', 'volume': '384', 'author': 'Group', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2023092721025247600_dkad295-B23', 'doi-asserted-by': 'crossref', 'first-page': 'eabi5273', 'DOI': '10.1126/science.abi5273', 'article-title': 'Estimating infectiousness throughout SARS-CoV-2 infection course', 'volume': '373', 'author': 'Jones', 'year': '2021', 'journal-title': 'Science'}, { 'key': '2023092721025247600_dkad295-B24', 'doi-asserted-by': 'crossref', 'first-page': '1525', 'DOI': '10.1093/cid/ciab686', 'article-title': 'SARS-CoV-2 viremia is associated with COVID-19 severity and predicts ' 'clinical outcomes', 'volume': '74', 'author': 'Jacobs', 'year': '2021', 'journal-title': 'Clin Infect Dis'}, { 'key': '2023092721025247600_dkad295-B25', 'doi-asserted-by': 'crossref', 'first-page': '6612', 'DOI': '10.1038/s41467-021-26884-7', 'article-title': 'Organ-specific genome diversity of replication-competent SARS-CoV-2', 'volume': '12', 'author': 'Van Cleemput', 'year': '2021', 'journal-title': 'Nat Commun'}, { 'key': '2023092721025247600_dkad295-B26', 'doi-asserted-by': 'crossref', 'first-page': '886', 'DOI': '10.1016/j.cmi.2021.02.014', 'article-title': 'Prolonged SARS-CoV-2 cell culture replication in respiratory samples ' 'from patients with severe COVID-19', 'volume': '27', 'author': 'Folgueira', 'year': '2021', 'journal-title': 'Clin Microbiol Infect'}, { 'key': '2023092721025247600_dkad295-B27', 'doi-asserted-by': 'crossref', 'first-page': 'e2898', 'DOI': '10.1093/cid/ciaa1316', 'article-title': 'Detection of severe acute respiratory syndrome coronavirus 2 ' '(SARS-CoV-2) RNA in blood of patients with coronavirus disease 2019 ' '(COVID-19): what does it mean?', 'volume': '73', 'author': 'Jacobs', 'year': '2021', 'journal-title': 'Clin Infect Dis'}, { 'key': '2023092721025247600_dkad295-B28', 'doi-asserted-by': 'crossref', 'first-page': '460', 'DOI': '10.1001/jama.2020.10044', 'article-title': 'Effect of convalescent plasma therapy on time to clinical improvement ' 'in patients with severe and life-threatening COVID-19: a randomized ' 'clinical trial', 'volume': '324', 'author': 'Li', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '2023092721025247600_dkad295-B29', 'doi-asserted-by': 'crossref', 'first-page': 'm3939', 'DOI': '10.1136/bmj.m3939', 'article-title': 'Convalescent plasma in the management of moderate covid-19 in adults in ' 'India: open label phase II multicentre randomised controlled trial ' '(PLACID trial)', 'volume': '371', 'author': 'Agarwal', 'year': '2020', 'journal-title': 'BMJ'}, { 'key': '2023092721025247600_dkad295-B30', 'doi-asserted-by': 'crossref', 'first-page': '1382', 'DOI': '10.1056/NEJMoa2102685', 'article-title': 'Bamlanivimab plus etesevimab in mild or moderate Covid-19', 'volume': '385', 'author': 'Dougan', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2023092721025247600_dkad295-B31', 'doi-asserted-by': 'crossref', 'first-page': 'e81', 'DOI': '10.1056/NEJMoa2108163', 'article-title': 'REGEN-COV antibody combination and outcomes in outpatients with ' 'Covid-19', 'volume': '385', 'author': 'Weinreich', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2023092721025247600_dkad295-B32', 'doi-asserted-by': 'crossref', 'first-page': '575', 'DOI': '10.1186/s12879-022-07560-7', 'article-title': 'Safety and efficacy of convalescent plasma for severe COVID-19: a ' 'randomized, single blinded, parallel, controlled clinical study', 'volume': '22', 'author': 'Rojas', 'year': '2022', 'journal-title': 'BMC Infect Dis'}, { 'key': '2023092721025247600_dkad295-B33', 'doi-asserted-by': 'crossref', 'first-page': '879', 'DOI': '10.1186/s12879-022-07716-5', 'article-title': 'Convalescent or standard plasma versus standard of care in the ' 'treatment of COVID-19 patients with respiratory impairment: short and ' 'long-term effects. A three-arm randomized controlled clinical trial', 'volume': '22', 'author': 'Manzini', 'year': '2022', 'journal-title': 'BMC Infect Dis'}, { 'key': '2023092721025247600_dkad295-B34', 'doi-asserted-by': 'crossref', 'first-page': 'e048337', 'DOI': '10.1136/bmjopen-2020-048337', 'article-title': 'Convalescent plasma for treatment of COVID-19: study protocol for an ' 'open randomised controlled trial in Sweden', 'volume': '11', 'author': 'Dillner', 'year': '2021', 'journal-title': 'BMJ Open'}], 'container-title': 'Journal of Antimicrobial Chemotherapy', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/jac/advance-article-pdf/doi/10.1093/jac/dkad295/51771535/dkad295.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/jac/advance-article-pdf/doi/10.1093/jac/dkad295/51771535/dkad295.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 9, 27]], 'date-time': '2023-09-27T21:35:05Z', 'timestamp': 1695850505000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkad295/7283037'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 9, 26]]}, 'references-count': 34, 'URL': 'http://dx.doi.org/10.1093/jac/dkad295', 'relation': {}, 'ISSN': ['0305-7453', '1460-2091'], 'subject': ['Infectious Diseases', 'Pharmacology (medical)', 'Pharmacology', 'Microbiology (medical)'], 'published': {'date-parts': [[2023, 9, 26]]}}

Late treatment
is less effective

Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.

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