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Trial - NCT04801667


Column Value
Trial registration number NCT04801667
Full text link
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04801667

First author
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Helio Tedesco Silva Junior

Contact
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

2021-03-17

Recruitment status
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adults over 18 years old; time after transplantation greater than 3 months; time after treatment with anti-thymocyte globulin longer than 4 weeks; able and willing (in the investigator's opinion) to comply with all study requirements; provide written informed consent

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination; prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by adenovirus, any vaccines against coronavirus); administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine; any history of angioedema or anaphylaxis; pregnancy, lactation or willingness / intention to become pregnant during the study; diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); history of severe psychiatric illness that possibly affects your participation in the study; hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after im injections or venipuncture; continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban); current suspected or known addiction to alcohol or drugs.

Number of arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

1

Funding
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Hospital do Rim e Hipertensão

Inclusion age min
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

3371

primary outcome
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Evaluate the incidence of hospitalization or death in 28 days associated with COVID-19 (symptomatic cases confirmed virologically by COVID -19 with positive CRP) 14 ± 2 days after the second dose of the vaccine.

Notes
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;IM", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]