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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 |
|
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"}] |