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. 2021 Oct 1;131(19):e151697.
doi: 10.1172/JCI151697.

Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19

Ravindra Ganesh  1 , Colin F Pawlowski  2 , John C O'Horo  1 , Lori L Arndt  3 , Richard F Arndt  3 , Sarah J Bell  1 , Dennis M Bierle  1 , Molly Destro Borgen  1 , Sara N Hanson  4 , Alexander Heyliger  1 , Jennifer J Larsen  1 , Patrick J Lenehan  2 , Robert Orenstein  5 , Arjun Puranik  2 , Leigh L Speicher  6 , Sidna M Tulledge-Scheitel  1 , A J Venkatakrishnan  2 , Caroline G Wilker  7 , Andrew D Badley  1 , Raymund R Razonable  1
Affiliations

Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19

Ravindra Ganesh et al. J Clin Invest. .

Abstract

BACKGROUNDClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed.METHODS2335 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.RESULTSThe 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).CONCLUSIONSAmong 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.FUNDINGMayo Clinic.

Keywords: Drug therapy; Virology.

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Conflict of interest statement

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 Regeneron and Roche and is a member of the DSMB for Novartis.

Figures

Figure 1
Figure 1. Study population, participant selection, and propensity matching.
Figure 2
Figure 2. Cumulative incidence of hospitalization over time in bamlanivimab-treated and propensity-matched untreated control population.
Bamlanivimab cohort median observed follow-up time = 27.0 days, IQR = (48.0, 70.0); 1-to-1 matched control median observed time = 28.0 days, IQR = (47.0, 70.0). Orange line, untreated matched controls; blue line, bamlanivimab-treated patients..
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