Status:
WITHDRAWN
Asymptomatic COVID-19 Trial
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The coronavirus disease-2019 (COVID-19) is spreading throughout the United States. While there are no known therapies to treat those who have become sick, there have been some reports that a medicatio...
Detailed Description
Participants will be randomized into one of two treatment plans 1. Hydroxycholoquine sulfate in combination with Azithromycin Hydroxycholorquine as above, plus Azithromycine: 500 mg po for day 1and t...
Eligibility Criteria
Inclusion
- Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment
- Age ≥20
Exclusion
- 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
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04374552
Start Date
May 5 2020
End Date
April 1 2021
Last Update
November 2 2020
Active Locations (1)
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1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903