Leronlimab Clinical Trials (2026): 13 Studies for Coronavirus Disease 2019 & COVID-19 Pneumonia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
13 Leronlimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 10 indications (including Coronavirus Disease 2019 & COVID-19 Pneumonia) and 1,753 total planned enrollment. 2 Phase 3 Leronlimab trials and 8 Phase 2 are listed. 1 Leronlimab clinical trial is actively recruiting at 1 U.S. site across 1 state. Most recent activity: NCT06699836 (Mar 2028).
Where to Participate: All Leronlimab Trial Sites in the U.S. (1 site across 1 state)
Every actively recruiting Leronlimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| NY | Weill Cornell Medicine Brain Health Imaging Institute | New York10065 | NCT07553338 | Map |
Leronlimab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | suspended | available | no longer available | Total |
|---|---|---|---|---|---|---|---|---|---|
| P1/P2 | 1 | 1 | |||||||
| P2 | 1 | 1 | 5 | 1 | 8 | ||||
| P3 | 2 | 2 | |||||||
| N/A | 1 | 1 | 2 |
Recruiting Leronlimab clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07553338 | SALIENT-ADSafety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease | P2 | Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease | 20 | Apr 2026 |
Leronlimab clinical trials by indication
Coronavirus Disease 2019 (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04347239 | — | P2 | completed | Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 |
| NCT04343651 | — | P2 | completed | Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 |
| NCT04678830 | — | P2 | completed | Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 |
COVID-19 Pneumonia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04901689 | COVID-19 | P3 | suspended | Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation |
| NCT04901676 | — | P3 | suspended | Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia |
Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07553338 | SALIENT-AD | P2 | recruiting | Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease |
Metastatic Colorectal Cancer (mCRC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06699836 | CLOVER | P2 | active not recruiting | The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER) |
CCR5 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05730673 | — | P2 | withdrawn | Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer |
Nonalcoholic Steatohepatitis (NASH) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04521114 | NASH | P2 | completed | Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis |
Solid Tumor, Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04504942 | PRO 140 | P2 | completed | Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors |
Triple Negative Breast Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03838367 | PRO 140 | P1/P2 | terminated | Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC |
TNBC (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07536815 | EAP | N/A | available | An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC) |
Metastatic Triple-Negative Breast Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04313075 | — | N/A | no longer available | A Compassionate Use Study of Leronlimab in Breast Cancer |
Leronlimab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| COVID-19 | NCT04901689 | P3 | suspended | COVID-19 Pneumonia | 316 | — |
| CLOVER | NCT06699836 | P2 | active not recruiting | Metastatic Colorectal Cancer (mCRC) | 66 | — |
| SALIENT-AD | NCT07553338 | P2 | recruiting | Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease | 20 | — |
| PRO 140 | NCT04504942 | P2 | completed | Solid Tumor, Adult | 16 | — |
| NASH | NCT04521114 | P2 | completed | Nonalcoholic Steatohepatitis (NASH) | 87 | PMID 27549244 |
Terminated and withdrawn Leronlimab trials (4)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05730673withdrawnLeronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer
- NCT04901689suspendedLeronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
- NCT04901676suspendedLeronlimab in Moderately Ill Patients With COVID-19 Pneumonia
- NCT03838367terminatedLeronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC
All Leronlimab trials (13)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06699836 | CLOVER | The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER) | P2 | active not recruiting | 66 | CytoDyn, Inc. | Jun 2025 |
| NCT07553338 | SALIENT-AD | Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease | P2 | recruiting | 20 | Weill Medical College of Cornell University | Apr 2026 |
| NCT07536815 | EAP | An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC) | — | available | 0 | CytoDyn, Inc. | — |
| NCT04504942 | PRO 140 | Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors | P2 | completed | 16 | CytoDyn, Inc. | May 2020 |
| NCT05730673 | Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer | P2 | withdrawn | 0 | CytoDyn, Inc. | Sep 2022 | |
| NCT04901689 | COVID-19 | Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation | P3 | suspended | 316 | Hospital Israelita Albert Einstein | Oct 2021 |
| NCT04901676 | Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia | P3 | suspended | 612 | Hospital Israelita Albert Einstein | Sep 2021 | |
| NCT03838367 | PRO 140 | Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC | P1/P2 | terminated | 10 | CytoDyn, Inc. | Apr 2019 |
| NCT04347239 | Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 | P2 | completed | 484 | CytoDyn, Inc. | Apr 2020 | |
| NCT04521114 | NASH | Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis | P2 | completed | 87 | CytoDyn, Inc. | Dec 2020 |
| NCT04343651 | Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 | P2 | completed | 86 | CytoDyn, Inc. | Apr 2020 | |
| NCT04678830 | Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 | P2 | completed | 56 | CytoDyn, Inc. | Mar 2021 | |
| NCT04313075 | A Compassionate Use Study of Leronlimab in Breast Cancer | — | no longer available | 0 | CytoDyn, Inc. | — |
Leronlimab clinical trials: frequently asked questions
- How many Leronlimab clinical trials are there?
- 13 Leronlimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 5 are marked completed.
- Are Leronlimab clinical trials recruiting in 2026?
- Yes — 1 Leronlimab trial is actively recruiting in 2026, with 1 U.S. site across 1 state. See the recruiting trials and the per-state site list further down this page.
- What conditions is Leronlimab being studied for?
- Leronlimab is being studied for Coronavirus Disease 2019, COVID-19 Pneumonia, Colorectal Cancer, Metastatic, Metastatic Colorectal Cancer (mCRC) and 11 more. The trials are grouped by indication on this page.
- What phase is Leronlimab in?
- Leronlimab clinical trials span 2 Phase 3, 8 Phase 2. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Leronlimab clinical trials?
- The lead sponsor across the most Leronlimab trials is CytoDyn, Inc., with 2 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Leronlimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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