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| Column | Value |
|---|---|
| Trial registration number | NCT05289206 |
|
Full text link
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
2022-03-21 |
|
Recruitment status
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Single group assignment |
|
Masking
Last imported at : March 22, 2022, 10 a.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 : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
inclusion criteria: have voluntarily participated and be in regular follow-up monitoring by the covacmanaus study; have completed the vaccination schedule with 2 doses of coronavac, as per the covacmanaus study protocol for at least 180 days (+/- 30 days); demonstrate availability to be followed during the follow-up period defined in the study, through visits, telephone contacts or other digital means of communication; accept to participate in this new study for 6 (six) months. exclusion criteria confirmed diagnosis of covid-19 within the last 28 days (antigen test or rt-pcr). in this situation, vaccination can be postponed until the participant completes 30 days; report of fever within 72 hours prior to vaccination (inclusion can be postponed until the participant completes 72 hours without fever and covid-19 is discarded); having received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study; any other condition that, in the opinion of the principal investigator or its medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol; pregnancy or lactation. |
|
Exclusion criteria
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
1 |
|
Funding
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado |
|
Inclusion age min
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
49 |
|
Countries
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Brazil |
|
Type of patients
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : May 7, 2022, 5 a.m. Source : ClinicalTrials.gov |
4446 |
|
primary outcome
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein |
|
Notes
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : March 22, 2022, 10 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |