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Asymptomatic COVID-19 Trial

NCT ID: NCT04374552

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Study medication will be tablets containing either active drug or placebo

Study Groups

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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

Group Type EXPERIMENTAL

Hydroxychloroquine sulfate &Azithromycin

Intervention Type DRUG

Drug - Hydroxychloroquine sulfate \&Azithromycin

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug - placebo

Interventions

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Hydroxychloroquine sulfate &Azithromycin

Drug - Hydroxychloroquine sulfate \&Azithromycin

Intervention Type DRUG

Placebo

Drug - placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey L Carson, MD

Distinguished Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey L Carson, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Pro2020000872

Identifier Type: -

Identifier Source: org_study_id