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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05233826 |
|
Full text link
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
2022-02-10 |
|
Recruitment status
Last imported at : Jan. 14, 2023, 4 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Single group assignment |
|
Masking
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: men and women aged 18 to 65 years of age, inclusive, on the day of signing the icf body mass index (bmi) ≤ 35 kg/m2 in good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the investigator previous receipt of an authorised mrna or adenovirus-vectored covid-19 vaccine with completion of vaccine regimen ≥ 3 months before day 1 |
|
Exclusion criteria
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
residents of residential care facilities pregnant or lactating women inadequate venous access for repeated phlebotomy history of confirmed or suspected sars-cov-2 infection |
|
Number of arms
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
1 |
|
Funding
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Codagenix, Inc |
|
Inclusion age min
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : April 23, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
United Kingdom |
|
Type of patients
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 14, 2023, 4 p.m. Source : ClinicalTrials.gov |
20 |
|
primary outcome
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Humoral Immunogenicity;Humoral Immunogenicity;Humoral Immunogenicity;Humoral Immunogenicity measured by neutralizing antibodies;Humoral Immunogenicity measured by neutralizing antibodies;Humoral Immunogenicity measured by neutralizing antibodies |
|
Notes
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Feb. 11, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 349, "treatment_name": "Covi-vac", "treatment_type": "Live attenuated virus", "pharmacological_treatment": "Vaccine"}] |