ABSTRACT
BACKGROUND: The highly contagious COVID-19 has created unprecedented challenges in providing care to patients with resectable non-small cell lung carcinoma (NSCLC). Surgical management now needs to consider the risks of malignant disease progression by delaying surgery, and those of COVID-19 transmission to patients and operating room staff. The goal of our study was to describe our experience in providing both emergent and elective surgical procedures for patients with NSCLC during the COVID-19 pandemic in Israel, and to present our point of view regarding the safety of performing lung cancer surgery. METHODS: This observational cross-sectional study included all consecutive patients with NSCLC who operated at Tel Aviv Medical Center, a large university-affiliated hospital, from February 2020 through December 2020, during the COVID-19 pandemic in Israel. The patients' demographics, COVID-19 preoperative screening results, type and side of surgery, pathology results, morbidity and mortality rates, postoperative complications, including pulmonary complications management, and hospital stay were evaluated. RESULTS: Included in the study were 113 patients, 68 males (60.2%) and 45 females (39.8%), with a median age of 68.2 years (range, 41-89). Of these 113 patients, 83 (73.5%) underwent video-assisted thoracic surgeries (VATS), and 30 (26.5%) underwent thoracotomies. Fifty-five patients (48.7%) were preoperatively screened for COVID-19 and received negative results. Fifty-six postoperative complications were reported in 35 patients (30.9%). A prolonged air leak was detected in 11 patients (9.7%), atrial fibrillation in 11 patients (9.7%), empyema in 5 patients (4.4%), pneumonia in 9 patients (7.9%) and lobar atelectasis in 7 patients (6.2%). Three patients (2.7%) with postoperative pulmonary complications required mechanical ventilation, and two of them (1.6%) underwent tracheostomy. Two patients (1.6%) were postoperatively diagnosed as positive for COVID-19. CONCLUSIONS: Our data demonstrate the feasibility and efficacy of implementing precautionary strategies to ensure the safety of lung cancer patients undergoing pulmonary resection during the COVID-19 pandemic. The strategy was equally effective in protecting the surgical staff and healthcare providers, and we recommend performing lung cancer surgery during the pandemic era.
ABSTRACT
A small but significant proportion of COVID-19 patients develop life-threatening cytokine storm. We have developed a new anti-inflammatory drug, EXO-CD24, a combination of an immune checkpoint (CD24) and a delivery platform (exosomes). CD24 inhibits the NF-kB pathway and the production of cytokines/chemokines. EXO-CD24 discriminates damage-from pathogen-associated molecular patterns (DAMPs and PAMPs) therefore does not interfere with viral clearance. EXO-CD24 was produced and purified from CD24-expressing 293-TREx™ cells. Exosomes displaying murine CD24 (mCD24) were also created. EXO-CD24/mCD24 were characterized and examined, for safety and efficacy, in vitro and in vivo. In a phase Ib/IIa study, 35 patients with moderate-high severity COVID-19 were recruited and given escalating doses, 108 -1010 , of EXO-CD24 by inhalation, QD, for 5 days. No adverse events related to the drug were observed up to 443-575 days. EXO-CD24 effectively reduced inflammatory markers and cytokine/chemokine, although randomized studies are required. EXO-CD24 may be a treatment strategy to suppress the hyper-inflammatory response in the lungs of COVID-19 patients and further serve as a therapeutic platform for other pulmonary and systemic diseases characterized by cytokine storm.