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| Column | Value |
|---|---|
| Trial registration number | NCT04828538 |
|
Full text link
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
drjosearturoyanez@gmail.com |
|
Registration date
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-04-02 |
|
Recruitment status
Last imported at : Nov. 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Factorial |
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Masking
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 19, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
positive sars-cov-2 test group (target enrollment: n=1,800) nutrovid treat trial: adult men/women recently diagnosed with covid-19 (positive pcr test for sars-cov-2 coronavirus) within <=5 days of symptom onset; and satisfying one of these risk factors: >=50 years old; or diabetic & >=40 years old; or obese & >=40 years old. negative sars-cov-2 test group (target enrollment: n=1,800) nutrovid prevent trial: adult men/women recently tested negative for covid-19 (negative pcr test for sars-cov-2 coronavirus); and satisfying one of these risk factors: >=50 years old; or diabetic & >=40 years old; or obese & >=40 years old. signed informed consent form |
|
Exclusion criteria
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- patients requiring immediate intubation or deemed likely to die within 48 hours. - patients deemed likely for transfer to an icu within 48 hours. - patients currently taking oral corticosteroids for any reason at the time of presentation for care. - patients included in any other interventional trial. - uncontrolled bacterial superinfection. - severe chronic kidney disease (stage 4) or requiring dialysis (i.e. egfr < 30). - pregnant women or women who are breastfeeding. - immunocompromised patients. - any patient with recent treatment (past 30 days) of immunosuppressive agents including (but not restricted to) dmards, corticosteroids, antibody therapy, intravenous immunoglobulins etc. - patients with acute myocardial infarction. |
|
Number of arms
Last imported at : Nov. 19, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
8 |
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Funding
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Hospital de la Soledad |
|
Inclusion age min
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mexico |
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Type of patients
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Nov. 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Nov. 19, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
Covid infection rate (PREVENT Trial only);Incidence of severe outcome (TREAT Trial only) |
|
Notes
Last imported at : April 6, 2021, 12:31 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 : Nov. 19, 2021, 7:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2286, "treatment_name": "Omega dha/epa+vitamin b+vitamin c+vitamin d+zinc", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2287, "treatment_name": "Omega dha/epa+vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2288, "treatment_name": "Vitamin b+vitamin c+vitamin d+zinc", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2289, "treatment_name": "Omega dha/epa+vitamin b+vitamin c+zinc", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 926, "treatment_name": "Omega dha/epa", "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"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |