Person: CİNEL, İSMAİL HAKKI
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CİNEL
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İSMAİL HAKKI
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Publication Open Access A pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)(2022-11-01) GÜL, FETHİ; CİNEL, İSMAİL HAKKI; Gül F., Gönen Z. B. , Jones O., Taşlı N. P. , Zararsız G., Ünal E., Özdarendeli A., Şahin F., Eken A., Yılmaz S., et al.This is a single-center prospective, open-label, single arm interventional study to test the safety and efficacy of recently described ChipEXO™ for severe COVID-19 pneumonia. The ChipEXO™ is a natural product derived from convalescent human immune plasma of patients recovered from moderate COVID-19 infection. In September 2021, 13 patients with pending respiratory failure were treated with ChipEXO™ adapted for aerosolized formulation delivered via jet nebulizer. Patients received 1-5x1010 nano vesicle/5 mL in distilled water twice daily for five days as an add-on to ongoing conventional COVID-19 treatment. The primary endpoint was patient safety and survival over a 28-day follow-up. The secondary endpoint was longitudinal assessment of clinical parameters following ChipEXO™ to evaluate treatment response and gain insights into the pharmacodynamics. ChipEXO™ was tolerated well without any allergic reaction or acute toxicity. The survival rate was 84.6% and 11 out of 13 recovered without any sequel to lungs or other organs. ChipEXO™ treatment was effective immediately as shown in arterial blood gas analyses before and two hours after exosome inhalation. During the 5 days of treatment, there was a sustainable and gradual improvement on oxygenation parameters: i.e. respiratory rate (RR) [20.8% (P < 0.05)], oxygen saturation (SpO2) [6,7% (P < 0.05)] and partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) [127.9% (P < 0.05)] that correlated with steep decrease in the disease activity scores and inflammatory markers, i.e. the sequential organ failure assessment (SOFA) score (75%, p < 0.05), C-reactive protein (46% p < 0.05), ferritin (58% p = 0.53), D-dimer (28% p=0.46). In conclusion, aerosolized ChipEXO™ showed promising safety and efficacy for life-threatening COVID-19 pneumonia. Further studies on larger patient populations are required to confirm our findings and understand the pathophysiology of improvement toward a new therapeutic agent for the treatment of severe COVID-19 pneumonia.Publication Open Access Cytokine Adsorption in Critically Ill COVID-19 Patients, a Case-Control Study(2022-09-01) ABDULLAYEV, RUSLAN; BİLGİLİ, BELİZ; SEVEN, SEDA; CİNEL, İSMAİL HAKKI; GÜL, FETHİ; Abdullayev R., Gül F., Bilgili B., Seven S., Cinel I.Aim: New coronavirus disease (COVID-19) has become an international emergency. As many of the intensive care unit (ICU) patients with the disease also present multiple organ failure, blood purification techniques might be a good choice in their treatment. In this study we aimed to investigate the role of cytokine removal in COVID-19 patients managed in ICUs. Methods: For this case-control study we have investigated the role of the cytokine removal by means of two resin membranes (HA330 and Mediasorb) in COVID-19 patients managed in ICUs. Particularly, we investigated the overtime variation in clinical severity scores, laboratory variables, and effects on hospital and ICU stay and mortality. Results: Seventy-two patients have been evaluated, of which half constituted Cytokine Filtration (CF) Group, and other half the Case-Control (CC) Group. Mortality was 55.6% and 50% in CF and CC groups, respectively. In the CF Group, there was decrease in C-reactive protein (CRP) and fibrinogen levels measured at the end of cytokine adsorption; lymphocyte count and ratio were increased, whereas neutrophile ratio was decreased. There were no differences between the groups regarding other laboratory variables, SOFA scores and vasopressor uses. Conclusions: We have demonstrated decrease in CRP, fibrinogen and increase in lymphocyte count in the patients having cytokine adsorption, but there was no clinical reflection of these benefits, and no decrease in mortality as well. Even though there is physio-pathologic rationale to use cytokine adsorption techniques for immunomodulation in critically ill COVID-19 patients, it is early to make strong suggestions about their benefits.Publication Open Access Impact of tocilizumab on clinical outcomes in severe COVID-19 patients and risk of secondary infection: A case-control study(MARMARA UNIV, FAC MEDICINE, 2021-05-25) ERTÜRK ŞENGEL, BUKET; Sengel, Buket Erturk; Ozel, Serra; Gul, Fethi; Ilgin, Can; Tigen, Elif Tukenmez; Altunal, Luftiye Nilsun; Kabadayi, Feyyaz; Sili, Uluhan; Aydin, Mehtap; Odabasi, Zekaver; Cinel, Ismail; Korten, VolkanObjective: This study aimed to identify the effect of tocilizumab (TCZ) on clinical outcomes in severe COVID-19 patients. Material and Methods: We included hospitalized COVID-19 patients with an initial WHO scale >= 4. We matched the patients with baseline characteristics by using propensity scores. Then, we selected patients with C-reactive protein levels above 30 and showing an upward trend. We assessed the effect of TCZ in patients on clinical outcomes by using Mann - Whitney U and Chi-square tests. Results: Of 200 patients who had an initial WHO scale >= 4, 42 (21%) were given it? in addition to standard of care (SOC). Twenty-five patients (50%) needed mechanical ventilation (MV) in the TCZ group, compared with 35 (21%) of 158 patients with SOC (p<0.01). Nineteen (45%) and 37 (23%) patients died in 30 days in these groups, respectively (p <0.01). The secondary infection rate was significantly higher in the TCZ group (p=0.004). However, no difference was observed in all these parameters in the propensity score-matched cohort (14 patients in ICZ and 14 in the SOC group) (p=0.45, 0.45, 1.0 respectively). Conclusions: Tocilizumab does not provide a beneficial effect on MV requirement and mortality in severe COVID-19, and it does not increase the risk of secondary bacterial infection.