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Trial - NCT04816071


Column Value
Trial registration number NCT04816071
Full text link
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04816071

First author
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Gohar Azhar, MD

Contact
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-25

Recruitment status
Last imported at : May 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 27, 2021, 12:31 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 : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - exposure to covid-19 in the last 60 days with no symptoms, with a covid negative test close contact: within 6 feet of a covid-19 positive person for more than a few minutes without wearing ppe, or having direct contact with infectious secretions without ppe - positive covid-19 test with or without symptoms

Exclusion criteria
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- covid-19 positive hospitalized patient - patients who have symptoms of covid but have not been tested. - unable to tolerate oral intake - in hospice or palliative care - unstable medical or psychiatric condition - other criteria deemed acceptable by principle investigator

Number of arms
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University of Arkansas

Inclusion age min
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

55

Inclusion age max
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : May 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Improvement in symptoms

Notes
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : March 27, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "non-vaccinated vs vaccinated", "treatment_id": 478, "treatment_name": "Essential amino acids", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "non-vaccinated vs vaccinated", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "non-vaccinated vs vaccinated", "treatment_id": 478, "treatment_name": "Essential amino acids", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "non-vaccinated vs vaccinated", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]