Asymptomatic COVID-19 Trial (ACT)

Rutgers The State University of New Jersey

Status and phase: Withdrawn; Phase 2

Conditions: SARS-CoV-2 Infection

Treatments: Drug: Placebo; Drug: Hydroxychloroquine sulfate &Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04374552

Pro2020000872

Details and patient eligibility

About

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 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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Hydroxychloroquine & Azithromycin

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine sulfate &Azithromycin

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo