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NCT04678830 · ClinicalTrials.gov registry record · Phase 2
Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19
A Phase 2 study of Coronavirus Disease 2019, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT04678830: Completed Phase 2 study of Coronavirus Disease 2019, sponsored by CytoDyn.
NCT04678830 is a Phase 2 study of Coronavirus Disease 2019 that has completed, run by CytoDyn. The registered enrollment target is 56 participants, below the 459-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04678830, a Phase 2 study of Coronavirus Disease 2019, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (\> 12 weeks) of COVID-19.
Primary Outcome
Changes in common COVID-19-related symptoms were evaluated daily by the patient using a patient diary between start and end of treatment. The diary is shown in Appendix 17.1 in the protocol and covers patient-reported changes for symptoms (ranked as none = 0, mild = 1, moderate = 2 or severe = 3) of cough, sore throat, stuffy or runny nose, difficulty breathing, feeling tightness in chest, feeling fast heartbeat, fatigue, exertional malaise, muscle aches and cramps, muscle weakness, joint pain a
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Leronlimab (700mg)
Study Locations (2)
Florida
- Arthritis & Rheumatic Disease Specialties - Aventura
Georgia
- Center for Advanced Research & Education (CARE) - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 2 |
What the finished NCT04678830 record still lists
NCT04678830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 459-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Coronavirus Disease 2019 appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT04678830 reports a single indexed study location in Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04678830 about?
NCT04678830 is a clinical study titled "Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19". The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (\> 12 weeks) of COVID-19.
What is the current status of trial NCT04678830?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2021-03-01. Estimated completion is 2021-07-08.
What conditions does trial NCT04678830 study?
This clinical trial studies the following conditions: Coronavirus Disease 2019.
What interventions are being tested in trial NCT04678830?
The interventions under investigation include: Placebos (DRUG), Leronlimab (700mg) (DRUG).
Who is sponsoring clinical trial NCT04678830?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678830 being conducted?
This trial has 2 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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