Created at Source Raw Value Validated value
April 21, 2022, 7:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I/IIa; open label study to determine the safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein in the EDV and a glycolipid a-galactosyl ceramide (EDV-plasmid-spike-GC) in non-COVID-19 infected volunteers; 18 years and older.Participants who are enrolled into Cohort 1 will receive 0.6mL intramuscular dose of 8 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 1 completion); new participants will be assigned to Cohort 2; receiving 0.6mL intramuscular dose of 9 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 2 completion); new participants will be assigned to Cohort 3; receiving 0.6mL intramuscular dose of 1 x 10^10 EDV-plasmid-spike-GC. Cohorts 1-3 will still enroll 6 participants each.The dose level of 9 x 10^9 EDV-plasmid-spike-GC has been determined by the Safety Committee to be the most safe and efficacious. All new participants will now be administered this dose level; up to 200 participants total.All doses will be administered in clinic with 3 hour safety monitoring on dosing days. This includes vital signs; laboratory tests and adverse event monitoring.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 1971, "treatment_name": "Edv-plasmid-spike-gc", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]

Dec. 22, 2021, 4:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I; open label study to determine the safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein in the EDV and a glycolipid a-galactosyl ceramide (EDV-plasmid-spike-GC) in non-COVID-19 infected volunteers; 18 years and older.Participants who are enrolled into Cohort 1 will receive 0.6mL intramuscular dose of 8 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 1 completion); new participants will be assigned to Cohort 2; receiving 0.6mL intramuscular dose of 9 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 2 completion); new participants will be assigned to Cohort 3; receiving 0.6mL intramuscular dose of 1 x 10^10 EDV-plasmid-spike-GC. Cohorts 1-3 will still enroll 6 participants each.Once a recommended dose level has been identified from Cohorts 1-3; recruitment will continue at said dose level up to a total of 40 participants.All doses will be administered in clinic with 3 hour safety monitoring on dosing days. This includes vital signs; laboratory tests and adverse event monitoring.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 1971, "treatment_name": "Edv-plasmid-spike-gc", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]

Sept. 1, 2021, 11 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I; open label study to determine the safety of EDV nanocells packaged with a plasmid encoding SARS-CoV-2 spike protein in the EDV and a glycolipid a-galactosyl ceramide (EDV-plasmid-spike-GC) in non-COVID-19 infected volunteers; 18 years and older. Participants who are enrolled into Cohort 1 will receive 0.6mL intramuscular dose of 8 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 1 completion); new participants will be assigned to Cohort 2; receiving 0.6mL intramuscular dose of 9 x 10^9 EDV-plasmid-spike-GC. Once the safety and tolerability of this dose level has been confirmed (and approximately within 1 week of Cohort 2 completion); new participants will be assigned to Cohort 3; receiving 0.6mL intramuscular dose of 1 x 10^10 EDV-plasmid-spike-GC. All doses will be administered in clinic with 3 hour safety monitoring on dosing days. This includes vital signs; laboratory tests and adverse event monitoring.6 participants will be enrolled per cohort up to a maximum of 18 in total.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]