TY - JOUR
T1 - Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19
AU - Ganesh, Ravindra
AU - Pawlowski, Colin F.
AU - O'Horo, John C.
AU - Arndt, Lori L.
AU - Arndt, Richard F.
AU - Bell, Sarah J.
AU - Bierle, Dennis M.
AU - Borgen, Molly Destro
AU - Hanson, Sara N.
AU - Heyliger, Alexander
AU - Larsen, Jennifer J.
AU - Lenehan, Patrick J.
AU - Orenstein, Robert
AU - Puranik, Arjun
AU - Speicher, Leigh L.
AU - Tulledge-Scheitel, Sidna M.
AU - Venkatakrishnan, A. J.
AU - Wilker, Caroline G.
AU - Badley, Andrew D.
AU - Razonable, Raymund R.
N1 - Funding Information:
Conflict of interest: CFP, AP, AJV, and PJL are employees of nference and own equity in the company. JCO is supported by grants from nference and is a paid consultant for Elsevier Inc. and Bates College. ADB is supported by a grant from Amfar (no. 109593), is a paid consultant for Abbvie and Flambeau Diagnostics, is a paid member of the Data and Safety Monitoring Board (DSMB) for Corvus Pharmaceuticals and Equilium, owns equity for scientific advisory work in Zentalis and nference, and is founder and president of Splissen Therapeutics. RRR is supported by research grants from Regen-eron and Roche and is a member of the DSMB for Novartis. Copyright: © 2021, American Society for Clinical Investigation. Submitted: May 24, 2021; Accepted: August 13, 2021; Published: October 1, 2021. Reference information: J Clin Invest. 2021;131(19):e151697. https://doi.org/10.1172/JCI151697.
Funding Information:
ADB is supported by grants from the National Institute of Allergy and Infectious Diseases (grants AI110173 and AI120698). Additional members of the MATRx team are listed in the supplemental material. They are all affiliated with the Mayo Clinic and did not receive compensation for their work in establishing the Mayo Clinic Monoclonal Antibody Infusion Program. Mayo Clinic as the funding entity did not have any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Mayo Clinic did not retain the right to veto publication or dictate which journal the paper should be submitted to. This work was funded by an intramural grant from Mayo Clinic to RRR. The sponsor did not have any influence in the design, conduct, or interpretation of the study and in the decision to publish the study outcomes.
Publisher Copyright:
© 2021, American Society for Clinical Investigation.
PY - 2021/10
Y1 - 2021/10
N2 - BACKGROUND. Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed. METHODS. 2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28. RESULTS. The median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower all-cause mortality at days 14 (0% vs. 0.33%), 21 (0.05% vs. 0.4%; RR,0.13), and 28 (0.11% vs. 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19 of 2355 patients, and were most commonly fever (n = 6), nausea (n = 5), and lightheadedness (n = 3). CONCLUSIONS. Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission, and mortality compared with usual care.
AB - BACKGROUND. Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed. METHODS. 2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28. RESULTS. The median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower all-cause mortality at days 14 (0% vs. 0.33%), 21 (0.05% vs. 0.4%; RR,0.13), and 28 (0.11% vs. 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19 of 2355 patients, and were most commonly fever (n = 6), nausea (n = 5), and lightheadedness (n = 3). CONCLUSIONS. Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission, and mortality compared with usual care.
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U2 - 10.1172/JCI151697
DO - 10.1172/JCI151697
M3 - Article
C2 - 34411003
AN - SCOPUS:85116220749
SN - 0021-9738
VL - 131
JO - Journal of Clinical Investigation
JF - Journal of Clinical Investigation
IS - 19
M1 - e151697
ER -