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| Column | Value |
|---|---|
| Trial registration number | NCT04364022 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
alexandra.calmy@hcuge.ch |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-27 |
|
Recruitment status
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: documented close contact with a person with either a pcr-confirmed sars-cov-2 or a positive rapid sars-cov-2 antigen test (as per standard of care). enrolment of the participant no more than 7 days since last contact with index case; ≥ 16 years of age; informed consent as documented by signature (including parent's or legal guardian's signature if the participant is between 16 and 18 y.o.). exclusion criteria*: fever (temperature >38.0°c) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia; individuals with previous confirmed sars-cov-2 infection, dating within the last six months ; known impairment of liver function; known hypersensitivity to the study medications; use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker individuals on boosted protease inhibitor (other than lpv) or boosted elvitegravir as part of an antiretroviral therapy inability to be followed-up for the trial period documented vaccination against sars-cov-2 where necessary, additional biological and clinical assessment will be performed, based on clinical judgement. |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Calmy Alexandra |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
16 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Brazil;Switzerland |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Close contacts to covid patients |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
326 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis). |
|
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 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |