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Trial - NCT04754698


Column Value
Trial registration number NCT04754698
Full text link
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04754698

First author
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Kallas, MD, PhD

Contact
Last imported at : June 25, 2021, 2 a.m.
Source : ClinicalTrials.gov

Eloisa Bonfa, eloisa.bonfa@hc.fm.usp.br (PI email not reported)

Registration date
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-15

Recruitment status
Last imported at : March 27, 2024, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 17, 2021, 12:31 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 : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - ra patients according to the classification criteria of the european league against rheumatism (eular)/american college of rheumatology (acr). - patients with axial spondyloarthritis (asas criteria 2009) and psoriatic arthritis (caspar 2012 criteria). - sle patients according to the slicc classification criteria. - ssc patients according to the acr preliminary criteria. - patients with inflammatory myopathies according to the bohan and peter's criteria. - patients with primary vasculitis. - patients with pss (2002 american-european consensus group criteria and/or 2016 classification criteria of the eular/acr. - patients with primary aps (primary antiphospholipid syndrome) (sydney classification criteria). - patients with hiv-related illness.

Exclusion criteria
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- history of anaphylactic response to vaccine components. - acute febrile illness. - guillain-barré syndrome, decompensated heart failure (class iii or iv), demyelinating disease. - history of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks before. - history of having received blood products up to 6 months before the study. - individuals who do not accept to participate in the study and/or whose guardians do not agree to participate in the study. - hospitalized patients. - patients with severe conditions requiring hospitalization.

Number of arms
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University of Sao Paulo General Hospital

Inclusion age min
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 27, 2024, 8 p.m.
Source : ClinicalTrials.gov

2196

primary outcome
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Immunogenicity 1;Immunogenicity 2

Notes
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;21-28 day interval;patients with rhematic diseases", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;21-28 day interval;patients with PLWHA ", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;21-28 day interval;healthy controls ", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]