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NCT04343651 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
A Phase 2 study of Coronavirus Disease 2019, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 12
- Study locations
NCT04343651: Completed Phase 2 study of Coronavirus Disease 2019, sponsored by CytoDyn.
NCT04343651 is a Phase 2 study of Coronavirus Disease 2019 that has completed, run by CytoDyn. The registered enrollment target is 86 participants, below the 451-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (81% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04343651, a Phase 2 study of Coronavirus Disease 2019, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Primary Outcome
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \[0=none, 1=mild, 2=moderate, and 3=severe\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Leronlimab (700mg)
Study Locations (12)
California
- University of California, Los Angeles - Los Angeles
- Palmtree Clinical Research, Inc. - Palm Springs
- Eisenhower Health - Rancho Mirage
New York
- Montefiore Medical Center - The Bronx
- White Plains Hospital - White Plains
Connecticut
- Yale - New Haven
Georgia
- Center for Advanced Research & Education (CARE) - Gainesville
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
New Jersey
- Atlantic Health System Hospital - Morristown
North Carolina
- Novant Health - Charlotte
Ohio
- Ohio Health - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2021-09-20 |
| Phase | Phase 2 |
What the finished NCT04343651 record still lists
NCT04343651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 451-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Coronavirus Disease 2019 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04343651 lists 12 locations in 9 states (California, New York, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04343651 about?
NCT04343651 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19". This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
What is the current status of trial NCT04343651?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2020-04-01. Estimated completion is 2021-09-20.
What conditions does trial NCT04343651 study?
This clinical trial studies the following conditions: Coronavirus Disease 2019.
What interventions are being tested in trial NCT04343651?
The interventions under investigation include: Placebo (DRUG), Leronlimab (700mg) (DRUG).
Who is sponsoring clinical trial NCT04343651?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343651 being conducted?
This trial has 12 study locations across California, Connecticut, Georgia, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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