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NCT04358068 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04358068: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04358068 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04358068, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Primary Outcome
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
Interventions
- DRUG Hydroxychloroquine (HCQ)
- DRUG Azithromycin (Azithro)
- DRUG Placebo for Hydroxychloroquine
- DRUG Placebo for Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-05-13 |
| Est. Completion | 2020-07-08 |
| Phase | Phase 2 |
Why NCT04358068 stopped before completion
NCT04358068 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Hydroxychloroquine (HCQ) is the first listed.
NCT04358068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04358068 about?
NCT04358068 is a clinical study titled "Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19". The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
What is the current status of trial NCT04358068?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-05-13. Estimated completion is 2020-07-08.
What interventions are being tested in trial NCT04358068?
The interventions under investigation include: Hydroxychloroquine (HCQ) (DRUG), Azithromycin (Azithro) (DRUG), Placebo for Hydroxychloroquine (DRUG), Placebo for Azithromycin (DRUG).
Who is sponsoring clinical trial NCT04358068?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04358068's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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