Asymptomatic COVID-19 Trial

NCT04374552 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: Pro2020000872
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Hydroxychloroquine sulfate &Azithromycin

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)

Drug: Placebo

Interventions

Hydroxychloroquine sulfate &Azithromycin DRUG

Drug - Hydroxychloroquine sulfate \&Azithromycin

Hydroxychloroquine & Azithromycin

Placebo DRUG

Drug - placebo

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented SARS-CoV-2 infection by qPCR assay without symptoms consistent with COVID-19 within 1 week of enrollment
• Age ≥20

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jeffrey L Carson, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study medication will be tablets containing either active drug or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Medicine

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: May 5, 2020
• Primary Completion: November 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-05

Locations

US (1)