Asymptomatic COVID-19 Trial

Overview

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 medication currently used to treat rheumatoid arthritis, lupus, and malaria (Hydroxychloroquine sulfate, also known as Plaquenil) may help to lessen the chance or severity of illness, especially if combined with a medicine that treats other kinds of infections (Azithromycin, also known as Zithromax or Zmax or Zpak).

There are some people who test positive for the virus but who are otherwise not ill. Current standard of care is to advise these people to self-monitor but no treatment is offered. It is not known how many of these individuals will remain symptom free, and how many will become sick or how severe those symptoms will be. This study will randomize those people who do not have symptoms into one of three treatment plans 1) Hydroxycholoquine and Azithromycin, or 2) no active medication (placebo). All participants will be followed for 2 months.

The study will determine if there is any benefit to those who are asymptomatic to taking taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit from taking these medications.

Full Title of Study: “RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2020

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 then 250 mg QD for 4 days

2. no active medication (placebo)

All participants will be followed for 2 months. The primary aim is to determine if there is any benefit (reduced likelihood for development of fever and other symptoms of COVID-19 ) to taking only Hydroxychloroquine sulfate, or to taking Hydroxychloroquine sulfate in combination with Azithromycin, or if there is no benefit to taking these medications for this population.

Interventions

  • Drug: Hydroxychloroquine sulfate &Azithromycin
    • Drug – Hydroxychloroquine sulfate &Azithromycin
  • Drug: Placebo
    • Drug – placebo

Arms, Groups and Cohorts

  • Experimental: Hydroxychloroquine & Azithromycin
    • Hydroxychloroquine sulfate 400 mg po BID for day one and then 400 mg QD for 4 days Azithromycin 500 mg po on day one, followed by 250 mg po QD X 4 days
  • Placebo Comparator: Placebo
    • Placebo for Hydroxychloroquine sulfate (2 pills bid day one and then 2 tablets QD for 4 days) Placebo for Azithromycin (2 pills on day one and followed by 1 pill po QD x 4 days)

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcome is the rate of decline in viral load over the 10 days after randomization
    • Time Frame: 10 days
    • Change in SARS-CoV-2 viral from baseline to day 6

Participating in This Clinical Trial

Inclusion Criteria

1. Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment

2. Age ≥20

Exclusion Criteria

1. Retinal eye disease

2. Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

3. Known chronic kidney disease, stage 4 or 5 or receiving dialysis

4. 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)

5. Pregnancy or women who are breast feeding

6. Inability to tolerate oral medications

7. Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate

8. Allergy to adhesives

9. QTc interval > 450 mSEC for men and women

10. History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval

11. Non-English-speaking

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey L Carson, MD, Distinguished Professor of Medicine – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Jeffrey L Carson, MD, Principal Investigator, Rutgers, The State University of New Jersey
  • Overall Contact(s)
    • Jeffrey L Carson, MD, 732-235-7122, jeffrey.carson@rutgers.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.