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Asymptomatic COVID-19 Trial (ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374552
Recruitment Status : Not yet recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

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 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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Hydroxychloroquine sulfate &Azithromycin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study medication will be tablets containing either active drug or placebo
Primary Purpose: Treatment
Official Title: RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : April 2021


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374552


Contacts
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Contact: Jeffrey L Carson, MD 732-235-7122 jeffrey.carson@rutgers.edu
Contact: Helaine Noveck, MPH 732-235-6581 helaine.noveck@rutgers.edu

Locations
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United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Jeffrey L Carson, MD Rutgers, The State University of New Jersey
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Responsible Party: Jeffrey L Carson, MD, Distinguished Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04374552    
Other Study ID Numbers: Pro2020000872
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents