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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 is a Phase 1 study that was terminated before completion, run by Rapa Therapeutics. The registered enrollment target is 1 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04482699
The ClinicalTrials.gov registry entry for NCT04482699 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rapa Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04482699 reports 0 study locations.
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.
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