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NCT04860518 · ClinicalTrials.gov registry record · Phase 2
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
A Phase 2 study, sponsored by Faron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT04860518: Clinical Trial Phase 2 study, sponsored by Faron Pharmaceuticals.
NCT04860518 is a Phase 2 study that was terminated before completion, run by Faron Pharmaceuticals. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04860518, a Phase 2 study, was terminated before completion, sponsored by Faron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone. Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.
Primary Outcome
WHO 9-point ordinal scale: 0 - No detectable infection 1. \- Not hospitalized, no limitations on activities 2. \- Not hospitalized, limitation on activities 3. \- Hospitalized, not requiring supplemental oxygen 4. \- Hospitalized, requiring supplemental oxygen 5. \- Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. \- Hospitalized, on invasive mechanical ventilation 7. \- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RR
Interventions
- DRUG Dexamethasone
- DRUG IFN beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 2 |
Why NCT04860518 stopped before completion
NCT04860518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT04860518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04860518 about?
NCT04860518 is a clinical study titled "Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19". This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a ...
What is the current status of trial NCT04860518?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-08-23. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT04860518?
The interventions under investigation include: Dexamethasone (DRUG), IFN beta-1a (DRUG).
Who is sponsoring clinical trial NCT04860518?
This trial is sponsored by Faron Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04860518's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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