At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 484 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Leronlimab (700mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
In Brief
A Phase 2 clinical trial evaluating Placebo and Leronlimab (700mg) for Coronavirus Disease 2019. Completed, enrolled 484 participants across 18 sites.
Detailed Summary
The purpose of this study was assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronavirus Disease 2019
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartApr 2020
Primary CompletionOct 2021
Study CompletionJun 2022
TodayJul 2026
First PostedApr 15, 2020
Enrollment StartApr 16, 2020
Primary CompletionOct 24, 2021
Study CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.2 years ago
Interventions
Placebodrug
Placebo
Leronlimab (700mg)drug
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)