Asymptomatic COVID-19 Trial (ACT)
Primary Purpose
SARS-CoV-2 Infection
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine sulfate &Azithromycin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria:
- Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment
- Age ≥20
Exclusion Criteria:
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Known chronic kidney disease, stage 4 or 5 or receiving dialysis
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)
- Pregnancy or women who are breast feeding
- Inability to tolerate oral medications
- Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
- Allergy to adhesives
- QTc interval > 450 mSEC for men and women
- History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
- Non-English-speaking
Sites / Locations
- Robert Wood Johnson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydroxychloroquine & Azithromycin
Placebo
Arm 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
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04374552
First Posted
May 2, 2020
Last Updated
October 29, 2020
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04374552
Brief Title
Asymptomatic COVID-19 Trial
Acronym
ACT
Official Title
RCT in Asymptomatic Volunteers With COVID-19 Comparing Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone vs Standard of Care Without Antibiotics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The investigators have decided not to go forward with this protocol
Study Start Date
May 5, 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Hydroxycholoquine sulfate in combination with Azithromycin Hydroxycholorquine as above, plus Azithromycine: 500 mg po for day 1and then 250 mg QD for 4 days
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study medication will be tablets containing either active drug or placebo
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine & Azithromycin
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine sulfate &Azithromycin
Intervention Description
Drug - Hydroxychloroquine sulfate &Azithromycin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug - placebo
Primary Outcome Measure Information:
Title
The primary outcome is the rate of decline in viral load over the 10 days after randomization
Description
Change in SARS-CoV-2 viral from baseline to day 6
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment
Age ≥20
Exclusion Criteria:
Retinal eye disease
Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
Known chronic kidney disease, stage 4 or 5 or receiving dialysis
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)
Pregnancy or women who are breast feeding
Inability to tolerate oral medications
Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
Allergy to adhesives
QTc interval > 450 mSEC for men and women
History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
Non-English-speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Carson, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Asymptomatic COVID-19 Trial
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