SARS-CoV-2Phase 2NCT04336332
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
A Phase 2 study testing Hydroxychloroquine Sulfate + Azithromycin and Hydroxychloroquine Sulfate in people with SARS-CoV-2 and COVID-19, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- Hydroxychloroquine Sulfate + Azithromycin and Hydroxychloroquine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2020to 14 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Robert Wood Johnson University Hopsital
New Brunswick, New Jersey, 08901
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
The University Hospital
Newark, New Jersey, 07103
University Hospital-Newark
Newark, New Jersey, 07112
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.
SECONDARY OBJECTIVES:
- Time to resolution of symptoms (symptom questionnaire)
II. Change in the fever curve resulting in shorter time to afebrile for 48 hours
III. Normalization of vital signs
IV. Time to discharge (if hospitalized)
- Assessment of agent toxicity as measured by standard metrics
VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies
VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions)
VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF
IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- Hydroxychloroquine Sulfate + Azithromycin, Hydroxychloroquine Sulfate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate + AzithromycinCombination product
Also called Hydroxychloroquine, Plaquenil, Z-Pak, Zithromax
Given PO
Hydroxychloroquine SulfateDrug
Also called Hydroxychloroquine, Plaquenil
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and day six
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Apr 2020
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Why it stopped: Ineffectiveness of treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabiha Hussain, MD,MPH, Rutgers, The State University of New Jersey
- Investigators
- Sabiha Hussain, MD, Principal investigator, Rutgers, The State University of New JerseySteven K. Libutti, MD, FACS, Study chair, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336332
- Sponsor's protocol ID
- 002011
- Other IDs
- Pro2020000712, Pro2020000712
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2020
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
- ClinicalTrials.gov ID
- NCT04336332
- Acronym / sponsor ID
- 002011
- Conditions
- SARS-CoV-2, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ineffectiveness of treatment
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group.
SECONDARY OBJECTIVES:
- Time to resolution of symptoms (symptom questionnaire)
II. Change in the fever curve resulting in shorter time to afebrile for 48 hours
III. Normalization of vital signs
IV. Time to discharge (if hospitalized)
- Assessment of agent toxicity as measured by standard metrics
VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies
VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in oropharyngeal secretions)
VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF
IX. Routine standard of care labs obtained as part of the care of these patients such as differential white count, CRP, troponin and LFTs will be analyzed for correlative trends
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Hydroxychloroquine Sulfate + Azithromycin | Experimental | Combination Product: Hydroxychloroquine Sulfate + Azithromycin, Drug: Hydroxychloroquine Sulfate* 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. |
| Arm 2: Hydroxychloroquine Sulfate alone | Experimental | Drug: Hydroxychloroquine Sulfate• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine Sulfate + AzithromycinAlso: Hydroxychloroquine, Plaquenil, Z-Pak, ZithromaxGiven PO | Combination product | Arm 1: Hydroxychloroquine Sulfate + Azithromycin |
| Hydroxychloroquine SulfateAlso: Hydroxychloroquine, PlaquenilGiven PO | Drug | Arm 1: Hydroxychloroquine Sulfate + Azithromycin, Arm 2: Hydroxychloroquine Sulfate alone |
Primary outcome
Changes in Patients Viral Load
Time frame: Baseline and day six
Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Hussain, MD principal investigator
Rutgers, The State University of New Jersey
Steven K. Libutti, MD, FACS study chair
Rutgers Cancer Institute of New Jersey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine Sulfate + Azithromycin and Hydroxychloroquine Sulfate in people with SARS-CoV-2 and COVID-19, run by Rutgers, The State University of New Jersey at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Patients Viral Load (time frame: Baseline and day six). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.