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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: Completed Phase 3 study of COVID-19, sponsored by Novartis Pharmaceuticals.
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 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical response was defined as a) discharged alive; or b) No need for mechanical ventilation in any participants and no need for supplemental oxygen requirement (SpO2) in participants without pre-morbid O2 requirement.
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 |
What the finished NCT04358081 record still lists
NCT04358081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
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 lists 7 locations in 6 states (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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Where NCT04358081's enrollment target sits among peer trials
20 279th of 298 higher than 14 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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