Bamlanivimab for the treatment of COVID-19 in solid organ transplant recipients: early experience in one center

Early reports suggested that solid organ transplant (SOT) recipients may be at higher risk of hospitalization, intensive care unit (ICU) stay, and death compared to the general population.1 Of the 59 adult SOT patients who were diagnosed with Coronavirus Disease 2019 (COVID – 19) at Westchester Medical Center between March and August 2020, 63% required hospitalization, 19% required ICU stay, 14% required mechanical ventilation and 12% died. In a previous study of 482 SOT recipients with COVID-19 from more than 50 centers, a significant number of patients required hospitalization (78%), mechanical ventilation (31%), and 20.5% of patients died during a follow-up up to 28 days.2

Bamlanivimab is a recombinant neutralizing human monoclonal antibody that binds to the viral spike protein and blocks attachment to the human angiotensin converting enzyme 2 receptor. Bamlanivimab has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the treatment of patients with mild to moderate COVID-19 who are at high risk of progression to hospitalization.3 Compared to placebo, Bamlanivimab reduced hospitalizations and emergency room visits in high-risk study patients (2.9% vs 10.1%), but showed no benefit in patients hospitalized with COVID – 19.4 5 Since approval, we have started using Bamlanivimab routinely for our adult SOT patients and we present our early experience of its use in patients with a follow-up of at least 14 days after the infusion. Between November and early December 2020, of the 12 adult SOT patients diagnosed with COVID-19, 10 met current FDA EUA criteria for Bamlanivimab administration (6 kidney, 2 liver, 1 liver / kidney, and 1 heart) , while 2 patients did not meet the criteria (1 required hospitalization, 1 was asymptomatic). All ten patients had mild to moderate symptoms, did not require supplemental oxygen and / or hospitalization of COVID-19, and were treated with Bamlanivimab in the non-hospital setting. (Table 1The patients were predominantly male (80%), had a mean age of 53 (39-66) years, had a mean body mass index of 28.4 (20-35) and were on average 43 (10-79) months after transplant. Patients received an IV for an average of 3.3 (1–10) days after the onset of symptoms. Other interventions included lowering / discontinuing mycophenolate (40%) and lowering the calcineurin inhibitor dose (70%). In addition to underlying immunosuppression, patients had several other risk factors for disease progression, including age> 65 years (10%), diabetes (30%), chronic heart disease (40%), and chronic kidney disease (20%). Side effects were rare, with only one in 10 patients developing mild pruritus during the infusion. Patients were followed for an average of 22 (14–27) days with no progression of COVID-19 symptoms or requiring hospitalization. Compared to our centre’s previous experience, access to diagnostic tests and the reporting process was streamlined during the study period. This allowed us to intervene and offer monoclonal antibody treatment to our SOT patients very early in the disease process.

TABLE 1.
Characteristics of solid organ transplant recipients treated with Bamlanivimab
Age (years) / gender / transplant type Symptoms / days Chest X-ray SpO2 on ambient air Other risk factors for progression Follow-up (days)
58 / M liver

Nose stuffiness

6 days

N / A 98%

Heart disease,

Diabetes

27
60 / M liver

Cough

10 days

N / A 97% 27
56 / M Kidney

Fever, malaise

2 days

N / A 96%

BMI – 35

Diabetes, CKD

27
66 / M Liver / kidney

Cough, SOB

3 days

Bilateral opacities 92% Age> 65 years 24
40 / M Kidney

Fever, cough, diarrhea, malaise

1 day

Bilateral opacities 93%

Heart disease,

CKD

21
51 / M Hart

Fever, cough,

nasal stuffiness

1 day

N / A 96% 20
62 / M Kidney

Cough, stuffy nose

3 days

N / A 93%

Heart disease,

Diabetes

20
55 / M Kidney

Fever, cough

4 days

Transparent 97% 20
41 / M Kidney

Fever, malaise

1 day

N / A 98% 17
39 / M Kidney

Loss of smell, malaise

2 days

N / A 96% BMI – 35 14
  • Abbreviations: BMI, body mass index; CKD, chronic kidney disease; N / A, not available; SOB, shortness of breath.

In this study, following administration of Bamlanivimab to solid organ transplant patients diagnosed with mild to moderate COVID-19 in a non-hospital setting, no patient experienced worsening symptoms or required hospitalization.

CONFLICT OF INTEREST

AD, SL: Received Institutional Research Grant from Regeneron. All other authors of this manuscript do not disclose any conflict of interest as described by the Clinical Transplant

AUTHORS ‘CONTRIBUTIONS

All authors contributed to the conception, data collection, and writing of the manuscript.

STATEMENT OF AVAILABILITY OF DATA

The data supporting the findings of this study are available from the corresponding author upon reasonable request.

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