A Phase 1 interventional study of EXO-CD24 in SARS-CoV-2, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 1, Interventional, and Treatment
This is an open-label Phase I study, four dose escalation groups, to evaluate the safety of CD24-exosomes in patients with moderate/severe COVID-19 disease.
Patients with moderate/severe COVID-19 infection and factors predictive of a cytokine storm are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.
Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.
CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.
The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, isolated and purified from T-REx™-293 cells engineered to express CD24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. This enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 35 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Disease severity: Moderate/severe according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
Clinical and Imaging-based evaluation
Evidence of an exacerbated inflammatory process
Exclusion Criteria:
Group 1, 5 patients are treated with 1x10\^8 exosome particles per 2 ml saline. Group 2: 5 patients are treated with 5x10\^8 exosome particles per 2 ml saline. Group 3: 20 patients are treated with 1x10\^9 exosomes particles per 2 ml saline. Group 4: 5 patients are treated with 1x10\^10 exosomes particles per 2 ml saline. The drug is aerosolized in normal saline for inhalation and administered via a standard hospital-grade inhalation device, QD for 5 days. Study treatment is given as an add-on to the standard of care.
Drug: EXO-CD24
The study active treatment is EXO-CD24 -exosomes (natural nano-sized vesicles secreted by human cells) that were engineered to overexpress CD24, aerosolized in normal saline for inhalation via a standard hospital-grade inhalation device, QD for 5 days.
Primary safety endpoint: Adverse events
Number of adverse events, and adverse events leading to premature study termination.
Time frame: 35 days
Exploratory Endpoint: Alive at Day 5 without bronchospasms, unexpected infections, or clinical deterioration
A composite endpoint comprised of alive at Day 5 without bronchospasms, unexpected infections, or a significant clinical deterioration compared to Baseline
Time frame: 5 days
Exploratory Endpoint: Proportion of patients with respiratory rate ≤ 23/min for 24 hours
Proportion of patients with respiratory rate ≤ 23/min for 24 hours
Time frame: 5 days
Exploratory endpoint: Change in respiratory rate from baseline to Day 5
Change in respiratory rate from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Proportion of patients with SpO2 saturation ≥94% for at least 24 hours
Proportion of patients with SpO2 saturation ≥94% for at least 24 hours
Time frame: 5 days
Exploratory endpoint: Change in SpO2 saturation from baseline to Day 5
Change in SpO2 saturation from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Proportion of patients with no artificial ventilation after 5 days of treatment
Proportion of patients with no artificial ventilation after 5 days of treatment
Time frame: 5 days
Exploratory endpoint: Proportion of patients with a change in absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment
Proportion of patients with a change in the absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment
Time frame: 7 days
Exploratory endpoint: Change in the absolute lymphocyte count from baseline to Day 5
Change in the absolute lymphocyte count from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR), sustained for ≥48 hours after 5 days of treatment
Proportion of patients with a change in the neutrophil-to-lymphocyte ratio, sustained for ≥48 hours after 5 days of treatment
Time frame: 7 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5
Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5
Time frame: 5 days
Plan to share: No
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Tel-Aviv Sourasky Medical Center