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Trial - NCT04400890


Column Value
Trial registration number NCT04400890
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Marvin R McCreary

Contact
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

supplement4covid19@gmail.com

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

2020-05-26

Recruitment status
Last imported at : May 27, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Terminated

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

Treatment

Inclusion criteria
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - outpatients who test positive for infection with sars-cov-2. - age ≥45 years - mild covid-19 based on world health organization (who) baseline severity categorization - symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms. - patient must have access to the internet or a smartphone to complete surveys. - english-speaking patients

Exclusion criteria
Last imported at : Aug. 27, 2021, 8 p.m.
Source : ClinicalTrials.gov

- diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician - asymptomatic patients (e.g. patients who were screened without symptoms but tested positive) - known or suspected liver disease or hepatitis c - known kidney disease with estimate glomerular filtration rate (egfr) <60 - patients on warfarin, novel oral anticoagulants (noacs), hiv protease inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window. - allergy to grapes or rice. - co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe chronic obstructive pulmonary disease (copd) or congestive heart failure (chf)) - currently pregnant - hospitalization

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

2

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

Marvin McCreary, MD

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

45

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

100

Countries
Last imported at : Oct. 26, 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

Mild/moderate disease at enrollment

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

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

105

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

Hospitalization rates for COVID-19

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 2

Arms
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1693, "treatment_name": "Resveratrol+vitamin d3", "treatment_type": "Nutrition+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]