key: cord-0688786-i9e3hsch
authors: Jan, Muhammad Y.; Sayegh, Skye E.; Webb, Hanna T.; Adebiyi, Oluwafisayo; Anderson, Melissa D.; Mishler, Dennis P.; Yaqub, Muhammad S.; Taber, Tim; Sharfuddin, Asif A.
title: Bamlanivimab For Mild to Moderate COVID-19 in Kidney Transplant Recipients
date: 2021-06-26
journal: Kidney Int Rep
DOI: 10.1016/j.ekir.2021.06.012
sha: ee18d052e237ae05b79845e697fa9d7e81bc6f1a
doc_id: 688786
cord_uid: i9e3hsch

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KTRs with COVID-19 are considered high risk due to immunosuppressive(IS) medication use 9 .

Studies on the use of Bamlanivimab among KTRs are limited. To provide more insight on the use Bamlanivimab in KTRs we hereby report our experience with 24 KTRs.

Demographics:

This information is summarized in Table 1 .

Average time from symptom onset to SARS CoV-2 PCR results was 2.08  1.2 days. Most common symptoms included fatigue, fever and cough. 3/24 patients were tested prior to a scheduled procedure or due to positive contacts for SARS CoV-2. They were asymptomatic at the time of SARS CoV-2 PCR testing however developed symptoms subsequently. Mean time from diagnosis to Bamlanivimab infusion was 2.67  2.5 days. 62.5% KTRs received the infusion locally from their Primary Care or Emergency Department physician while 37.5% received it at our Transplant Center's designated COVID-19 infusion center. Majority of the patients reported resolution of symptoms with-in 31.4  15.9 hours after the infusion. None of the patients reported difficulty in arrangement of Bamlanivimab infusion. 3 patients reported side effects during or after the infusion which included nausea, headache , worsening of body aches for 1 day and rash on fingers. No anaphylactic reactions were reported. This is summarized in Table 1 .

J o u r n a l P r e -p r o o f Majority of patients 54.2 % (14/24) were on Tacrolimus and Mycophenolic acid(MPA) on a prednisone free regimen prior to COVID-19 Infection. 13/24 had no change to their IS regimen after COVID-19 diagnosis while 7/24 had MPA decreased to half or lower. 4/24(16.7%) patients required hospitalization all of whom required supplemental oxygen and 2 of whom required ICU care. One patient required mechanical ventilation, and dialysis therapy for AKI and died. Among those who required ICU admission one patient each was diagnosed with COVID Associated Pulmonary Aspergillosis (CAPA) and disseminated histoplasmosis later in the course and were treated with antifungal therapies. All admitted patients received dexamethasone for 10 days per COVID-19 Infection treatment protocol and 2/4 received Remdesivir. ICU patients received further dexamethasone based on DEXA-ARDS trial regimen 10 . This data is shown in Table 2 .

Clinical data on Bamlanivimab use in KTRs is currently limited. We hereby report its use, safety, effect on timeline of symptoms and outcomes in a real world setting. Majority of our patients avoided hospitalization, ICU admission and did not report any sequalae of COVID-19 in the follow up period. Previously Dhand 11 reported outcomes in 6 KTRs with none requiring hospitalization. In this report average time from onset of symptoms to infusion was 3.3 days 11 . In our study, mean time from onset of symptoms to infusion was 4.75 days however mean SARS CoV-2 PCR testing and return time was 2 days which accounted for nearly half the time. showed that combination therapy was successful in reducing day 11 viral load compared to Bamlanivimab alone. While it failed to show significant difference in the primary outcome, rates of hospitalization among patients who received 700 mg dose of Bamlanivimab, or combination therapy was 1% and 0.9% respectively compared to 5.8% in the placebo group, although it was significant only in the combination therapy group. Mean total symptom scores were also comparable between Bamlanivimab monotherapy and combination group 12 . Due to emerging SARS CoV-2 variants with resistance, the EUA for Bamlanivimab use alone has been withdrawn 13 , however combination monoclonal antibody therapies including (Bamlanivimab + Etesevimab) and (Casirivimab + Imdevimab) 14 still retain their EUA for use as previously authorized for Bamlinivimab alone.

Bamlanivimab was well tolerated with no significant major adverse effects or allergic reactions in our cohort which is similar to previously reported cases 11 and the BLAZE-1 trial 9,12 . Nausea (3.9%) was most common symptom in BLAZE-1 trial followed by diarrhea (3.2%). Infusion reactions occurred in 2.3% of the patients and included rash and pruritis 9 . Similar trends were seen in our study with 4.2% having a rash, 8.3% reporting nausea, and no reporting of diarrhea.

None of the side effects required discontinuation of the infusion.

Mortality rate of 4.2% in our series of KTRs was lower compared to those KTRs who had COVID-19 but did not receive Bamlanivimab infusion (9.4%) over the same timeframe. 

Covid-19 and Kidney Transplantation

Evidence of potent humoral immune activity in COVID-19-infected kidney transplant recipients

Early Outcomes of Outpatient Management of Kidney Transplant Recipients with Coronavirus Disease

Kidney allograft recipients, immunosuppression, and coronavirus disease-2019: a report of consecutive cases from a New York City transplant center

Outpatient management of kidney transplant recipients with suspected COVID-19-Single-center experience during the New York City surge

COVID-19 and kidney transplantation: Results from the TANGO International Transplant Consortium

Early Description of Coronavirus 2019 Disease in Kidney Transplant Recipients in New York

Fact Sheet for health care providers Emergency Use Authorization (EUA) of Bamlanivimab FDA. 2.67  2.5 days

*Infusion = Bamlanivimab Infusion, KT: Kidney Transplant, LD: Living Donor, DD:Deceased Donor, COVID-19: COVID-19 Infection, SARS CoV-2: Severe Acute Respiratory Syndrome Coronavirus 2

Table 2. Follow up and Outcomes Follow up after Bamlanivimab Mean 66.7  (20.7) days, Median 70 (23-113) 9.5 (days), median 11 (5-27 days) Site of Infusion* Transplant Infusion Center 37.5% Local Clinic/Hospital

AKI: Acute Kidney Injury, ‡ = at the time of admission to the hospital