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A pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)

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dc.contributor.authorGÜL, FETHİ
dc.contributor.authorCİNEL, İSMAİL HAKKI
dc.contributor.authorsGül F., Gönen Z. B. , Jones O., Taşlı N. P. , Zararsız G., Ünal E., Özdarendeli A., Şahin F., Eken A., Yılmaz S., et al.
dc.date.accessioned2022-11-29T11:09:22Z
dc.date.available2022-11-29T11:09:22Z
dc.date.issued2022-11-01
dc.description.abstractThis 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.
dc.identifier.citationGül F., Gönen Z. B. , Jones O., Taşlı N. P. , Zararsız G., Ünal E., Özdarendeli A., Şahin F., Eken A., Yılmaz S., et al., "A pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)", FRONTIERS IN IMMUNOLOGY, sa.10.3389/fimmu.2022.963309, ss.1-8, 2022
dc.identifier.doi10.3389/fimmu.2022.963309
dc.identifier.endpage8
dc.identifier.issn1664-3224
dc.identifier.issue10.3389/fimmu.2022.963309
dc.identifier.startpage1
dc.identifier.urihttps://avesis.marmara.edu.tr/api/publication/499b89b8-0c24-4049-ae72-ef63e1f59a3b/file
dc.identifier.urihttps://hdl.handle.net/11424/283340
dc.language.isoeng
dc.relation.ispartofFRONTIERS IN IMMUNOLOGY
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectSağlık Bilimleri
dc.subjectHealth Sciences
dc.subjectKlinik Tıp (MED)
dc.subjectClinical Medicine (MED)
dc.subjectCOVID-19
dc.subjectCoronavirus disease
dc.subjectSevere acute respiratory syndrome-coronavirus-2
dc.subjectSARS-CoV-2
dc.subjectexosomes
dc.subjectconvalescent plasma
dc.titleA pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)
dc.typearticle
dspace.entity.typePublication
local.avesis.id499b89b8-0c24-4049-ae72-ef63e1f59a3b
relation.isAuthorOfPublication907a6efd-2877-4832-b6a2-d87a28e52165
relation.isAuthorOfPublication202e7185-bae9-46db-9cdd-f2f0881870aa
relation.isAuthorOfPublication.latestForDiscovery907a6efd-2877-4832-b6a2-d87a28e52165

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