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NCT04482699 · ClinicalTrials.gov registry record · Phase 1
RAPA-501-Allo Therapy of COVID-19-ARDS
A Phase 1 study, sponsored by Rapa Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04482699: Clinical Trial Phase 1 study, sponsored by Rapa Therapeutics.
NCT04482699 is a Phase 1 study that was terminated before completion, run by Rapa Therapeutics. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482699, a Phase 1 study, was terminated before completion, sponsored by Rapa Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects. The randomized, double-blind, placebo-controlled Phase 2b study component will evaluate infusion of RAPA-501 ALLO off the shelf cells or a control infusion, with the primary endpoint assessing whether RAPA-501 cells reduce 30-day mortality. The COVID-19 pandemic is a disaster playing out with progressive morbidity and mortality. As of April 6th, 2021, an estimated 132.1 million people have contracted the virus and 2,866,000 deaths have resulted globally. The United States has the highest totals with an estimated 30.8 million people diagnosed and 556,000 deaths. In stages 1 and 2 of COVID-19, viral propagation within the patient is predominant. As such, therapeutic interventions focus on immune molecules (convalescent serum, monoclonal antibodies) and anti-viral medications (remdesivir). In marked contrast, the most severe and deadly form of COVID-19, stage 3, is driven not by viral propagation, but by an out-of-control immune response (hyperinflammation) caused by increases in immune molecules known as cytokines and chemokines. As such, therapeutic interventions for stage 3 disease focus on anti-inflammatory medications such as anti-cytokine therapy (anti-IL-6 drugs) or corticosteroid therapy. Unfortunately, such interventions do not address the full pathogenesis of stage 3 COVID-19, which includes hyperinflammation due to "cytokine storm" and "chemokine storm," tissue damage, hypercoagulation, and multi-organ failure (including lung, heart, kidney and brain). The pulmonary component of stage 3 disease includes acute respiratory distress syndrome (ARDS), which is a final-common-pathway of patient death due to a myriad of conditions, including pneumonia, sepsis, and trauma. There is a dire need for novel cellular treatments that can deliver
Primary Outcome
On the phase 1 study component, determine the safety of allogeneic RAPA-501 cells when administered at dose level 1 (Cohort 1, 40 x 106 cells) and dose level 2 (Cohort 2, 160 x 106 cells).
Interventions
- OTHER Placebo
- BIOLOGICAL RAPA-501-Allo off-the-shelf Therapy of COVID-19
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2021-09-13 |
| Phase | Phase 1 |
Why NCT04482699 stopped before completion
NCT04482699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04482699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04482699 about?
NCT04482699 is a clinical study titled "RAPA-501-Allo Therapy of COVID-19-ARDS". The first-in-human Phase 1 study component will evaluate two dose levels of RAPA-501-ALLO off the shelf cells in patients with COVID-19-related ARDS, with key endpoints of safety, biologic and potential disease-modifying effects. The randomized, double-blind, placebo-controlled Phase 2b study compon...
What is the current status of trial NCT04482699?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-12-30. Estimated completion is 2021-09-13.
What interventions are being tested in trial NCT04482699?
The interventions under investigation include: Placebo (OTHER), RAPA-501-Allo off-the-shelf Therapy of COVID-19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04482699?
This trial is sponsored by Rapa Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04482699's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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