Leronlimab Clinical Trials (2026): 13 Studies for Coronavirus Disease 2019 & COVID-19 Pneumonia

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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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.

StateFacilityCityTrialMap
NYWeill Cornell Medicine Brain Health Imaging InstituteNew York10065NCT07553338Map

Leronlimab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedterminatedwithdrawnsuspendedavailableno longer availableTotal
P1/P211
P211518
P322
N/A112

Recruiting Leronlimab clinical trials (1)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07553338SALIENT-ADSafety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's DiseaseP2Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease20Apr 2026

Leronlimab clinical trials by indication

Coronavirus Disease 2019 (3)

NCTAcronymPhaseStatusTitle
NCT04347239P2completedEvaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19
NCT04343651P2completedStudy to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
NCT04678830P2completedDouble Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19

COVID-19 Pneumonia (2)

NCTAcronymPhaseStatusTitle
NCT04901689COVID-19P3suspendedLeronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation
NCT04901676P3suspendedLeronlimab in Moderately Ill Patients With COVID-19 Pneumonia

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (1)

NCTAcronymPhaseStatusTitle
NCT07553338SALIENT-ADP2recruitingSafety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease

Metastatic Colorectal Cancer (mCRC) (1)

NCTAcronymPhaseStatusTitle
NCT06699836CLOVERP2active not recruitingThe Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)

CCR5 (1)

NCTAcronymPhaseStatusTitle
NCT05730673P2withdrawnLeronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer

Nonalcoholic Steatohepatitis (NASH) (1)

NCTAcronymPhaseStatusTitle
NCT04521114NASHP2completedLeronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis

Solid Tumor, Adult (1)

NCTAcronymPhaseStatusTitle
NCT04504942PRO 140P2completedBasket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors

Triple Negative Breast Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT03838367PRO 140P1/P2terminatedLeronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC

TNBC (1)

NCTAcronymPhaseStatusTitle
NCT07536815EAPN/AavailableAn 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)

NCTAcronymPhaseStatusTitle
NCT04313075N/Ano longer availableA 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
COVID-19NCT04901689P3suspendedCOVID-19 Pneumonia316
CLOVERNCT06699836P2active not recruitingMetastatic Colorectal Cancer (mCRC)66
SALIENT-ADNCT07553338P2recruitingMild Cognitive Impairment (MCI) Due to Alzheimer's Disease20
PRO 140NCT04504942P2completedSolid Tumor, Adult16
NASHNCT04521114P2completedNonalcoholic Steatohepatitis (NASH)87PMID 27549244

Terminated and withdrawn Leronlimab trials (4)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06699836CLOVERThe Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)P2active not recruiting66CytoDyn, Inc.Jun 2025
NCT07553338SALIENT-ADSafety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's DiseaseP2recruiting20Weill Medical College of Cornell UniversityApr 2026
NCT07536815EAPAn 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)available0CytoDyn, Inc.
NCT04504942PRO 140Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid TumorsP2completed16CytoDyn, Inc.May 2020
NCT05730673Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal CancerP2withdrawn0CytoDyn, Inc.Sep 2022
NCT04901689COVID-19Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane OxygenationP3suspended316Hospital Israelita Albert EinsteinOct 2021
NCT04901676Leronlimab in Moderately Ill Patients With COVID-19 PneumoniaP3suspended612Hospital Israelita Albert EinsteinSep 2021
NCT03838367PRO 140Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBCP1/P2terminated10CytoDyn, Inc.Apr 2019
NCT04347239Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19P2completed484CytoDyn, Inc.Apr 2020
NCT04521114NASHLeronlimab (PRO 140) in Patients With Nonalcoholic SteatohepatitisP2completed87CytoDyn, Inc.Dec 2020
NCT04343651Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19P2completed86CytoDyn, Inc.Apr 2020
NCT04678830Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19P2completed56CytoDyn, Inc.Mar 2021
NCT04313075A Compassionate Use Study of Leronlimab in Breast Cancerno longer available0CytoDyn, 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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