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NCT04335552 · ClinicalTrials.gov registry record · Phase 2
Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04335552 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 11 participants.
The verdict
NCT04335552, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin
Interventions
- DRUG Azithromycin
- OTHER Standard of care
- DRUG Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-04-17 |
| Est. Completion | 2020-06-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04335552
The ClinicalTrials.gov registry entry for NCT04335552 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT04335552 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04335552 about?
NCT04335552 is a clinical study titled "Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection". This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid ...
What is the current status of trial NCT04335552?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2020-04-17. Estimated completion is 2020-06-26.
What interventions are being tested in trial NCT04335552?
The interventions under investigation include: Azithromycin (DRUG), Standard of care (OTHER), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04335552?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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