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Trial - IRCT20210708051820N1


Column Value
Trial registration number IRCT20210708051820N1
Full text link
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Anna Knight

Contact
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

anna.knight@invicta.pl

Registration date
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-08-06

Recruitment status
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

nonRCT

Allocation
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Non-randomized

Design
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Prevention

Inclusion criteria
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Willingness to take part in the clinical trial Age between 18 and 55 years old

Exclusion criteria
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Age above 55 years old Diagnosed with diabetes, hypertension, heart disease, chronic pulmonary diseases, severe allergies Obesity as defined by BMI > 30

Number of arms
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Invicta Research and Development Center

Inclusion age min
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

55

Countries
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Type of patients
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Healthy volunteers

Severity scale
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

N/A

Total sample size
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

35

primary outcome
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Anti-SARS-CoV-2 antibody level

Notes
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : Aug. 6, 2021, 5 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "2 doses at 15ug each, dose interval 21 days", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2 doses at 30ug each, dose interval 21 days", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]