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Trial - NCT04374552


Column Value
Trial registration number NCT04374552
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04374552

First author
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Jeffrey L Carson, MD

Contact
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

jeffrey.carson@rutgers.edu

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

2020-05-05

Recruitment status
Last imported at : Nov. 3, 2020, 11:31 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Withdrawn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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

single-center

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

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: documented sars-cov-2 infection by qpcr assay without symptoms consistent with covid-19 within 1 week of enrollment age ≥20

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

retinal eye disease known glucose-6 phosphate dehydrogenase (g-6-pd) deficiency known chronic kidney disease, stage 4 or 5 or receiving dialysis current use of: class 3 aad - amiodarone, dronaderone, dofetilide, sotalol) class 1a aad (procainamide, quinidine, disopyramide) flecainide chlorpromazine cilostazol (pletal) donepezil (aricept) droperidol fluconazole methadone ondansetron(zofran) thioridazine macrolides (clarithromycin, erythromycin) fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin) pregnancy or women who are breast feeding inability to tolerate oral medications allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate allergy to adhesives qtc interval > 450 msec for men and women history of torsade de pointes vt or prior cardiac arrest or congenital long qt interval non-english-speaking

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

Rutgers, The State University of New Jersey

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

20

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

None

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

United States

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

Mild disease at enrollment

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

1: Mild disease at enrollment

Total sample size
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0

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

The primary outcome is the rate of decline in viral load over the 10 days after randomization

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 2

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

[{"arm_notes": "Patients are asymptomatic", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Patients are asymptomatic", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]