Asymptomatic COVID-19 Trial (ACT)

RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics

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.

Study Overview

• Status: Withdrawn
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: Hydroxychloroquine sulfate &Azithromycin; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Hydroxychloroquine sulfate &Azithromycin; Drug - Hydroxychloroquine sulfate &Azithromycin
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)	Drug: Placebo; Drug - placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Anticipated): May 5, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: Pro2020000872

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No