Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
Study NCT ID:
NCT04336332
Status:
TERMINATED
Last Update Posted:
2023-02-28
First Post:
2020-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ineffectiveness of treatment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: