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Trial - NCT05308615


Column Value
Trial registration number NCT05308615
Full text link
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Erlina Burhan

Contact
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

2022-04-04

Recruitment status
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 5, 2022, 8:30 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 : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age 18-65 years old human resources in persahabatan central general hospital while being a research subject wear ppe according to their respective work standards. not previously infected with covid-19, or have been infected with covid-19 19 previously with non-reactive igg serological results. have not received a covid-19 vaccine or have received 2nd dose of vaccine covid-19 but manifest non-reactive igg serological results subject voluntarily gave written consent to participate in this research.

Exclusion criteria
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

patients with severe comorbid factors such as: uncontrolled congestive heart disease, renal insufficiency, coronary heart disease, chronic liver disease, diabetes mellitus with complications, uncontrolled hypertension or crisis hypertension, immunocompromised, cns disorders (such as stroke, epilepsy, alzheimer's, meningitis) , cancer, hiv, aids. subjects who are pregnant or breastfeeding. subjects who cannot be included in the study according to consideration of the researcher. subjects who are in the process of taking other drug clinical trials. subjects with a history of allergy to the components of the test drug.

Number of arms
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Indonesia University

Inclusion age min
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

92

primary outcome
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

The incidence of confirmed COVID-19 subjects from the results of PCR

Notes
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2413, "treatment_name": "Rhea health tone", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]