Trials / Terminated
TerminatedNCT04336332
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Rutgers, The State University of New Jersey · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Hydroxychloroquine Sulfate + Azithromycin | Given PO |
| DRUG | Hydroxychloroquine Sulfate | Given PO |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2020-10-14
- Completion
- 2020-10-14
- First posted
- 2020-04-07
- Last updated
- 2023-02-28
- Results posted
- 2023-02-28
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04336332. Inclusion in this directory is not an endorsement.