ABSTRACT
Introduction: Coronavirus disease 2019 COVID-19 is clearly the pandemic of the new millennium. COVID-19 determines multi organ dysfunction including the inflammatory immune responses of thyroid gland. Objective(s): To determine whether the involvement of the thyroid gland by COVID-19 manifests as thyroid hormonal changes and development of thyroid disorders. Method(s): We studied prospectively 60 patients with COVID-19 pneumonia,without previous known history of thyroid disease nor pre-existing endocrine disorders, hospitalized between May and July 2021, and we performed serum thyroid hormonal analysis within the first 24 hours after admission, including TSH, Free T3, Free T4 and their antithyroglobulin antibodies (Anti-TG and Anti-TPO), and correlate them with clinical and laboratory data. Result(s): Samples were collected from 60 patients (31 males, 51.7%). 32 out of 60 (53.3%) showed significantly lower values of TSH (0,29 +- 0,07 mIU/mL) with decreased Free T3 serum levels (2,07 +- 0,131 pmol/L) and the thyroid autoantibodies (both Anti-TG and Anti-TPO) were positive. These 32 patients (27 males) demonstrated moderate to critical illness and they needed high oxygen flow. The other 28 patients with no evidence of thyroid abnormalities showed mild to moderate COVID-19 pneumonia and none needed high oxygen flows. Conclusion(s): In our study, 32/60 (53.3%) patients with moderate to severe COPVID-19 pneumonia were diagnosed with thyroid abnormalities. Thus, the development and the progression of respiratory failure due to SARS-COV-2 may affect the thyroid function.
ABSTRACT
Background. EXO-CD24 is a novel inhaled drug of exosomes displaying CD24, a protein with anti-inflammatory properties. We evaluated the safety and potential efficacy of EXO-CD24, in a phase II, randomized, single-blinded clinical trial of EXO-CD24 in hospitalized patients with moderate or severe COVID-19, following the preliminary safety and efficacy results of a phase 1 study (ClinicalTrials.gov: NCT04747574). Methods. Two tertiary care hospitals in Athens, Greece participated. Patients received either 109 or 1010 exosome particles per dose, once per day for 5 days and were followed for 28 days. Safety and efficacy measures (including respiratory rate < 23 b/ min and pulse oximetry SpO2>= 94% on room air, oxygen need and levels of inflammatory biomarkers i.e. CRP, LDH, ferritin, fibrinogen and d-dimers) were compared between groups at days 3, 5 and 7. A separate analysis was conducted comparing the clinical course of treated patients with that of a control cohort (n=70 patients) matched by propensity scoring out of a similar period hospitalized cohort (n=202) that did not participate in the study. Results. Between June 9th and August 3rd 2021, 91 patients underwent randomization: 45 in group A and 46 in group B (109 vs. 1010 exosome particles per dose). Mean age was 49.4 (+/- 13.2) years and 74.4% were male. Mean time from symptom onset to randomization was 8 days. Improvement in respiratory rate and pulse oximetry was noted in 72 out of 86 (83.7%) and 55 out of 86 (64%) analyzed patients. Day 7 inflammatory indices levels dropped at least 50% from baseline admission values in 72 out of 86 (82.8%) analyzed patients (p< 0.001). No treatment-related adverse events were reported. Comparison with the propensity score matched group showed statistically significant differences in the same parameters (p<= 0.01 for all comparisons). Conclusion. Our results suggest safety and potential efficacy of EXO-CD24 on clinical and laboratory parameters of moderate or severe COVID-19, that deserve further investigation in a phase 3 study. (Funded by Athens Medical Society. ClinicalTrials.gov: NCT04902183, EU Clinical Trials Register EudraCT Number 2021-002184-22).