| Trial registration number
|
NCT04386252 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04386252
|
First author
Last imported at : May 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
|
Robert O Dillman
|
Contact
Last imported at : May 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
|
Not reported
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
2020-05-13
|
Recruitment status
Last imported at : May 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
|
Withdrawn
|
Study design
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
nonRCT
|
Allocation
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
Non-randomized
|
Design
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
Sequential assignment
|
Masking
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
Open label
|
Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
|
unclear
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Prevention
|
Inclusion criteria
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
- 18 years or older, in relatively good health with adequate physical and mental
function, including factors associated with in increased risk for medical
complications associated with covid-19 infection or increased risk for exposure to
sars-cov-2
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
- active covid-19 infection by pcr testing, pre-existing igg or igm sars-cov-2
antibodies, pregnant, known hypersensitivity to gm-csf, known active immune deficiency
disease or active hiv, hbv, hcv, on active treatment with corticosteroids or other
immunosupressive agent, participated in previous covid-19 vaccine study
|
Number of arms
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Aivita Biomedical, Inc.
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
18
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
None
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Healthy volunteers
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
N/A
|
Total sample size
Last imported at : May 4, 2023, 8 p.m.
Source : ClinicalTrials.gov
|
0
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
Confirm safety
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
|
Phase 1/Phase 2
|
Arms
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}]
|