Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19

NCT04336332 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 002011Pro2020000712
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.

Conditions

SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (1)

• Changes in Patients Viral Load

  Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.

  Baseline and day six

Study Arms (3)

Arm 1: Hydroxychloroquine Sulfate + Azithromycin

EXPERIMENTAL

* Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days * Azithromycin 500 mg taken by mouth on Day 1, followed by * Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.

Combination Product: Hydroxychloroquine Sulfate + Azithromycin; Drug: Hydroxychloroquine Sulfate

Arm 2: Hydroxychloroquine Sulfate alone

EXPERIMENTAL

• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days

Drug: Hydroxychloroquine Sulfate

Arm 3: Placebo

NO INTERVENTION

* Placebo pills Days 1-6. * If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days

Interventions

Hydroxychloroquine Sulfate + Azithromycin COMBINATION_PRODUCT

Given PO

Also known as: Hydroxychloroquine, Plaquenil, Z-Pak, Zithromax, Zmax

Arm 1: Hydroxychloroquine Sulfate + Azithromycin

Hydroxychloroquine Sulfate DRUG

Given PO

Also known as: Hydroxychloroquine, Plaquenil

Arm 1: Hydroxychloroquine Sulfate + Azithromycin; Arm 2: Hydroxychloroquine Sulfate alone

Eligibility Criteria

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

You may qualify if:

• Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19
• Ability to measure and quantify viral load by quantitative PCR
• Age 18 to 89
• Ability to swallow oral medications
• Patients must read, understand and sign IRB approved informed consent

You may not qualify if:

• Pregnancy or women who are breast feeding
• Two consecutive negative assays for SARS-CoV-2 infection
• Patients that lack decision-making capacity will not be approached to participate in this study
• Inability to tolerate oral medications
• Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
• QTc interval \> 470 mSEC
• History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria
• History of serious ventricular arrhythmia (VT or VF \> 3 beats in a row)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (5)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Robert Wood Johnson University Hopsital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

The University Hospital

Newark, New Jersey, 07103, United States

Location

University Hospital-Newark

Newark, New Jersey, 07112, 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

Results Point of Contact

• Title: Dr. Sabiha Hussain
• Organization: Cancer Institute of New Jersey

hussaisa@rwjms.rutgers.edu

+1 732-718-3253

Study Officials

• Sabiha Hussain, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Steven K. Libutti, MD, FACS

  Rutgers Cancer Institute of New Jersey

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: April 1, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: February 28, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)