COVID-19, SARS-CoV-2
Conditions
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.
Detailed description
PRIMARY OBJECTIVE: I. 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: I. 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) V. 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
Interventions
COMBINATION_PRODUCTHydroxychloroquine Sulfate + Azithromycin
Given PO
DRUGHydroxychloroquine Sulfate
Given PO
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Patients Viral Load | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Hydroxychloroquine Sulfate + Azithromycin * 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.
Hydroxychloroquine Sulfate + Azithromycin: Given PO
Hydroxychloroquine Sulfate: Given PO | 16 |
| Arm 2: Hydroxychloroquine Sulfate Alone • Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Hydroxychloroquine Sulfate: Given PO | 30 |
| Arm 3: Placebo * 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 | 29 |
| Total | 75 |
Baseline characteristics
| Characteristic | Arm 1: Hydroxychloroquine Sulfate + Azithromycin | Arm 2: Hydroxychloroquine Sulfate Alone | Arm 3: Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 5 Participants | 10 Participants | 11 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 19 Participants | 18 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 15 Participants | 20 Participants | 47 Participants |
| Region of Enrollment United States | 16 participants | 30 participants | 29 participants | 75 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 9 Participants | 20 Participants | 17 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 16 | 4 / 30 | 1 / 29 |
| other Total, other adverse events | 7 / 16 | 13 / 30 | 5 / 29 |
| serious Total, serious adverse events | 0 / 16 | 1 / 30 | 1 / 29 |
Outcome results
Primary
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.
Time frame: Baseline and day six
Population: Data were not collected