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Trial - NCT04751669


Column Value
Trial registration number NCT04751669
Full text link
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Teresa M Tomasa-Irriguible, MD-PhD

Contact
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-12

Recruitment status
Last imported at : March 26, 2024, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Feb. 16, 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 : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

inclusion criteria: informed consent form signed. patients with symptoms compatible with covid-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care. positive polymerase chain reaction (pcr) or transcription-mediated amplification (tma) test or rapid antigen test for severe acute respiratory syndrome corona virus-2 (sars-cov-2) or diagnostic test available. age ≥ 18 years availability to meet the requirements of the protocol.

Exclusion criteria
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

intake of any micronutrient supplement during the month prior to inclusion. patients fulfilling hospitalization criteria. previous allergies to the micronutrient components and excipients. age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease) participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form. detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol. any other findings that at the discretion of the researcher may compromise protocol performance or significantly influence the interpretation or results of the effects of the nutritional supplement pregnancy or breastfeeding

Number of arms
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Fundació Institut Germans Trias i Pujol

Inclusion age min
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 13, 2023, noon
Source : ClinicalTrials.gov

90

Countries
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : March 26, 2024, 8 p.m.
Source : ClinicalTrials.gov

252

primary outcome
Last imported at : March 26, 2024, 8 p.m.
Source : ClinicalTrials.gov

Incidence of Long Covid.;Need for hospital admission

Notes
Last imported at : Feb. 16, 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 : Feb. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 803, "treatment_name": "Micronutrients", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]