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NCT04511650 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
A Phase 2 study, sponsored by EyePoint Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT04511650: Clinical Trial Phase 2 study, sponsored by EyePoint Pharmaceuticals.
NCT04511650 is a Phase 2 study that was terminated before completion, run by EyePoint Pharmaceuticals. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511650, a Phase 2 study, was terminated before completion, sponsored by EyePoint Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID) (every 8 hours \[Q8H\]), in hospitalized subjects with moderate to severe Coronavirus disease 2019 (COVID-19) receiving standard of care therapy. The study was planned to include 2 parts with Part 1 comprising the dose escalation period of the study and Part 2 comprising the proof-of-concept safety and efficacy period of the study.
Primary Outcome
All results were summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95%CI of the difference between response rates, and p-values using Cochran-Mantel-Haenszel (CMH). The 95% CI will be constructed using the normal approximation method. Respiratory failure was defined as subjects who were on invasive mechanical ventilation; received oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow r
Interventions
- DRUG Razuprotafib Subcutaneous Solution
- DRUG Placebo Subcutaneous Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2021-02-26 |
| Phase | Phase 2 |
Why NCT04511650 stopped before completion
NCT04511650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Razuprotafib Subcutaneous Solution is the first listed.
NCT04511650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04511650 about?
NCT04511650 is a clinical study titled "Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019". This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID) (every 8 hours \[Q8H\]), in hospitalized subjects with moderate to severe Co...
What is the current status of trial NCT04511650?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2020-10-21. Estimated completion is 2021-02-26.
What interventions are being tested in trial NCT04511650?
The interventions under investigation include: Razuprotafib Subcutaneous Solution (DRUG), Placebo Subcutaneous Solution (DRUG).
Who is sponsoring clinical trial NCT04511650?
This trial is sponsored by EyePoint Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04511650's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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