Publication: A pilot study for treatment of severe COVID-19 pneumonia by aerosolized formulation of convalescent human immune plasma exosomes (ChipEXO™)
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Date
2022-11-01
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Abstract
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.
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Keywords
Sağlık Bilimleri, Health Sciences, Klinik Tıp (MED), Clinical Medicine (MED), COVID-19, Coronavirus disease, Severe acute respiratory syndrome-coronavirus-2, SARS-CoV-2, exosomes, convalescent plasma
Citation
Gül 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