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NCT04358081 · ClinicalTrials.gov registry record · Phase 3
Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease
A Phase 3 study of COVID-19, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT04358081 is a Phase 3 study of COVID-19 that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states.
The verdict
NCT04358081, a Phase 3 study of COVID-19, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounced when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-mediated activation of various innate immune pathways, as well as blockade of lysosomal functions in cell types relevant for viral entry and antigen presentation. The purpose of the study was to determine if oral hydroxychloroquine monotherapy, or in combination with azithromycin results in clinical benefit in patients hospitalized with COVID19 pneumonia.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HCQ
- DRUG HCQ+AZT
Study Locations (7)
California
- Novartis Investigative Site - Fullerton
- Novartis Investigative Site - Los Angeles
Illinois
- Novartis Investigative Site - Chicago
Louisiana
- Novartis Investigative Site - Baton Rouge
Maryland
- Novartis Investigative Site - Baltimore
North Carolina
- Novartis Investigative Site - Chapel Hill
Washington
- Novartis Investigative Site - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2020-07-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04358081
The ClinicalTrials.gov registry entry for NCT04358081 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04358081 reports 7 study locations spanning 6 distinct geographic areas - top geographies include California, Illinois, Louisiana.
Frequently Asked Questions
What is clinical trial NCT04358081 about?
NCT04358081 is a clinical study titled "Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease". Two recent studies have suggested that in patients with Covid19, treatment with hydroxychloroquine may shorten the duration of symptoms and improve viral clearance, an effect that appears most pronounced when combined with azithromycin. Hydroxychloroquine treatment may inhibit viral nucleic acid-med...
What is the current status of trial NCT04358081?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2020-05-01. Estimated completion is 2020-07-27.
What conditions does trial NCT04358081 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04358081?
The interventions under investigation include: Placebo (DRUG), HCQ (DRUG), HCQ+AZT (DRUG).
Who is sponsoring clinical trial NCT04358081?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04358081 being conducted?
This trial has 7 study locations across California, Illinois, Louisiana, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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