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Trial - NCT04330144


Column Value
Trial registration number NCT04330144
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04330144

First author
Last imported at : Aug. 10, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Yong Goo Song, Professor

Contact
Last imported at : Aug. 10, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

imfell@yuhs.ac

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-01

Recruitment status
Last imported at : Aug. 10, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Withdrawn

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

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - a contact person from confirmed case of sars-cov-2 infection - medical staff exposed from confirmed case of sars-cov-2 infection in hospitals - persons exposed to sars-cov-2 in covid-19 outbreak situation with certain workplaces, religious groups, and military, etc. - subjects of study include both symptomatic and asymptomatic contacts.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- hypersensitivity to chloroquine or hydroxychloroquine - those who are contraindicated in hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc. - human immunodeficiency virus (hiv) infected person - patients with autoimmune disease (systemic lupus erythematosus, mixed connective tissue disease) - patients with autoimmune rheumatoid inflammatory disease (aiird; autoimmune inflammatory rheumatic diseases - ankylosing spondylitis, rheumatic arthritis, psoriatic arthritis) - arrhythmia, liver cirrhosis of child pugh c, chronic renal failure with egfr≤30ml / min / 1.73m2 - a person who is positive in the covid-19 screening pcr test before starting pep

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

Gangnam Severance Hospital

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

99

Countries
Last imported at : Aug. 10, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

Korea;Republic of

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Aug. 10, 2021, 3:30 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

The rate of 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 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]