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| Column | Value |
|---|---|
| Trial registration number | NCT04647305 |
|
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Andrea Ramirez Varela, an-rami2@uniandes.edu.co (PI email not reported) |
|
Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-11-30 |
|
Recruitment status
Last imported at : April 29, 2021, 10:18 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - age 18 years or older - negative rt-pcr test at the beginning of the study. - negative sars-cov-2 serological elecsys anti-sars-cov-2 test at the beginning of the study. - living in a geographic area with active covid-19 transmission (number of - cases reported locally). - living in a geographic area that has been determined by the colombian national statistics department (dane) to have a medium, medium-high, and high vulnerability index (higher prevalence of comorbidities and social and economic vulnerabilities. - working outside the home for at least two days a week, during the last week. - acceptance to participate in the study regardless of the trial arm assignment through verbal informed consent. |
|
Exclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
- retired adults or unemployed - adults referring previous diagnosis of covid-19 confirmed by rt-pcr tests or serological antibody tests. |
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Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
University of Los Andes, Columbia |
|
Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Colombia |
|
Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
High risk patients |
|
Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
233 |
|
primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
COVID-19 incidence |
|
Notes
Last imported at : Dec. 3, 2020, 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 : Dec. 3, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 301, "treatment_name": "Closed face shield", "treatment_type": "Protective device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |