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The investigators have decided not to go forward with this protocol
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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.
Participants will be randomized into one of two treatment plans
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine & Azithromycin | Experimental | 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 | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine sulfate &Azithromycin | Drug | Drug - Hydroxychloroquine sulfate &Azithromycin |
|
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Study medication will be tablets containing either active drug or placebo
| Placebo | Drug | Drug - placebo |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |