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Trial - NCT04523246


Column Value
Trial registration number NCT04523246
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04523246

First author
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Barbara W. Carlson, RN, Ph.D.

Contact
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Barbara-Carlson@ouhsc.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-21

Recruitment status
Last imported at : Nov. 23, 2023, 4 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

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

inclusion criteria: meet centers for medicare and medicaid definition for long term care resident. 65 years and older. have already received or provide consent to receive the 2020 flu vaccine. negative screen (within the last 2 weeks) for covid 19 virus. has a history of chickenpox or shingles. able to read and speak english. able to provide informed consent and assent (with guardian/health care proxy).

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

brief interview of mental status (bims) score <8 (indicating severe dementia). prior vaccination with the shingrix. positive test for covid 19 or prior history of covid 19 infection. conditions that confound the interpretation of the innate immune measures. (i.e. terminal condition, receiving hospice, stage 3 and 4 open wound, chemotherapy, immune modulators or other immunosuppressants, autoimmune disorders, and bmi < 20 kg/m2). conditions that confound interpretation of respiratory symptoms. (i.e ventilator dependent, receiving more that 2-3 liters/min of oxygen by nasal cannula, chronic diarrhea, recurrent infections).

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov

University of Oklahoma

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

65

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 11, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

217

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Evidenced of active and trained innate immunity

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;day0-60", "treatment_id": 1193, "treatment_name": "Shingrix", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "2;day0-60", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]