Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT04336332
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
Study:
NCT04336332
Study Brief:
Protocol Section:
NCT04336332