COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04928456


Column Value
Trial registration number NCT04928456
Full text link
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04928456

First author
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Jesus Sanchez, DO

Contact
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

jsanchez@westernu.edu

Registration date
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-06-16

Recruitment status
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 18, 2021, 12:32 a.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 : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - are between the ages of 18 and 65 years old - will be receiving the mrna covid-19 vaccine at western university of health sciences - have signed an informed consent form - have not previously received a covid-19 vaccine

Exclusion criteria
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

- have contraindications to vaccine and any significant reactions to vaccines - have any primary or secondary immune deficiencies or autoimmune disease/immunocompromised - have symptoms of covid-19 at the time of enrollment (eg. fever, headaches, muscle pain, sore throat, coughing, loss of smell, loss of taste, etc.) - have already received a covid-19 vaccine - are using any immune altering medications such as corticosteroids, cyclospoin, tacrolimus, and pimecrolimus - are unable to receive omt with lymphatic techniques due to open wounds, fractures, anuresis, necrotizing faciitis, congestive heart failure, or unstable cardiac conditions - are pregnant or breastfeeding - are less than 18 years of age or more than 65 years of age - were previously treated for covid-19 with serum transfer or immunological treatments - are on anti-coagulation therapy

Number of arms
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Western University of Health Sciences

Inclusion age min
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

IgG antibody titer levels Percentage Change;IgM and IgG antibody titer duration;IgM antibody titer levels Percentage Change.

Notes
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : June 18, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2312, "treatment_name": "Osteopathic manipulative treatment", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]