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Asymptomatic COVID-19 Trial (ACT)

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ClinicalTrials.gov Identifier: NCT04374552
Recruitment Status : Withdrawn (The investigators have decided not to go forward with this protocol)
First Posted : May 5, 2020
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE May 2, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date November 2, 2020
Estimated Study Start Date  ICMJE May 5, 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asymptomatic COVID-19 Trial
Official Title  ICMJE RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE
  • Drug: Hydroxychloroquine sulfate &Azithromycin
    Drug - Hydroxychloroquine sulfate &Azithromycin
  • Drug: Placebo
    Drug - placebo
Study Arms  ICMJE
  • 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
    Intervention: 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)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 29, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2020)
140
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04374552
Other Study ID Numbers  ICMJE Pro2020000872
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey L Carson, MD Rutgers, The State University of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP