Coronavirus Disease 2019Phase 2NCT04347239

Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19

A Phase 2 study testing Leronlimab (700mg) in people with Coronavirus Disease 2019, run by CytoDyn, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronavirus Disease 2019
What is being tested?: Leronlimab (700mg)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 484 participants
Where: 18 sitesUnited States
Study dates: 16 Apr 2020to 15 Jun 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female adult ≥ 18 years of age at time of screening.
Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:
Severe Illness:
Diagnosed with COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent testing within 5 days of screening
AND
Symptoms of severe systemic illness/infection with COVID-19:

Show all 26Show fewer

At least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress
AND
Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:
respiration rate (RR) ≥ 30, heart rate (HR) ≥ 125, saturated oxygen (SaO2) <93% on room air or requires > 2L oxygen by nasal canula (NC) in order maintain SaO2 ≥93%, PaO2/FiO2 <300 (ratio of partial pressure of oxygen in arterial blood to fraction of inspired oxygen)
AND
None of the following: Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), Septic shock (defined by systolic blood pressure (SBP) < 90 mm Hg, or Diastolic BP < 60 mm Hg), Multiple organ dysfunction/failure
Critical Illness:
Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening
AND
Evidence of critical illness, defined by at least 1 of the following:
Respiratory failure defined based on resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (in setting of resource limitation)
OR
Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring vasopressors)
OR
-Multiple organ dysfunction/failure
Subject, if intubated, positive end expiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

Who cannot join

Subjects with do-not-resuscitate (DNR) and/or do-not-intubate (DNI) orders or expected to be made DNR/DNI in setting of resource limitations or family wishes.
Not a candidate for dialysis or continuation of care (or full medical support) in setting of resource limitations.
Subject on continuous vasopressors (at the dose of norepinephrine >20μg/min and/or vasopressin >0.04 units/kg/min) for >48 hours at time of screening.
Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
Inability to provide informed consent or to comply with test requirements
Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment

Show all 9Show fewer

Pregnancy or breast feeding
Subject participating in another study with for an investigational treatment for COVID-19.
Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
New York Community Hospital of Brooklyn
Brooklyn, New York, 11229
Ohio Health
Columbus, Ohio, 43215
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330
Baylor Scott & White Research Institute
Dallas, Texas, 75204
St. Jude Medical Center
Fullerton, California, 92835
Center for Advanced Research & Education (CARE)
Gainesville, Georgia, 30501
Baylor College of Medicine
Houston, Texas, 77030
University of Texas
Houston, Texas, 77030
St. Barnabas
Livingston, New Jersey, 07052
UCLA
Los Angeles, California, 90095
Atlantic Health System Hospital
Morristown, New Jersey, 07962-1905
Oregon Health and Sciences University
Portland, Oregon, 97239
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
Holy Name Medical Center
Teaneck, New Jersey, 07666
Montefiore Medical Center
The Bronx, New York, 10467
Novant Health
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

This was a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.

A single arm, non-randomized, open-label phase was added to the protocol after completion of enrollment in the randomized phase of the study.

The study had three phases: Screening Period, Treatment Period, and Follow-Up Period.

Conditions: Coronavirus Disease 2019
Being tested: Placebo, Leronlimab (700mg)
Keywords: COVID-19
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo
Leronlimab (700mg)Drug
Also called PRO 140
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Study groups in NCT04347239
Study group	Role	What they receive
Placebo	Placebo comparator	Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo. Receives: Drug: Placebo
700mg Leronlimab	Experimental	Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. Receives: Drug: Leronlimab (700mg)
700mg Leronlimab Open Label	Experimental	Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. Receives: Drug: Leronlimab (700mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause Mortality at Day 28
Incidence of mortality at day 28
Measured: Mortality at day 28 (Visit 2, start of treatment = day 0)

Secondary outcomes (4)

All-cause Mortality at Day 14
Day 0 refers to the data of randomization/first treatment.
Measured: Mortality at day 14 (initiation of treatment = day 0)
Proportion of Patients Achieving a Category of 6 or Higher on the Ordinal Scale at Days 14 and 28 (on a 7 Point Ordinal Scale).
Evaluation of the clinical status of participants at Day 28 was assessed with a 7-level ordinal scale (OS) (with higher score indicating better outcome).
The OS of patient health status ranged from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. The study enrolled hospitalized patients with an OS Score of 2, 3, or 4 at baseline. The OS score of 6 refers to a participant who is not hospitalized with limitation on activities and 7 refers to not hospitalized with no limitations on activities.
Measured: Change from baseline to days 14 and 28
Change in Clinical Status of Subjects at Day 28 (on a 7 Point Ordinal Scale)
Evaluation of the clinical status of participants at Day 28 was assessed with a 7-level ordinal scale (OS) (with higher score indicating better outcome).
The OS of patient health status ranged from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. The study enrolled hospitalized patients with an OS Score of 2, 3, or 4 at baseline.
Baseline is last available value before treatment. Change from baseline is based on patients with paired values. The p value is from rank ANCOVA model adjusted for stratification factor and age using imputed data. All results and change from baseline are based on the result of multiple imputation.
Measured: Change from start of treatment (baseline) to day 28
Length of Hospital Stay
Length of Hospital Stay measured in days
Measured: Timeframe is from screening visit to end of treatment (visit 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 202015 Jun 2022

First posted15 Apr 2020
Study start16 Apr 2020
Primary completion24 Oct 2021
Study completion15 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: There were 394 participants randomized to the blinded portion of the study using an Interactive Response Technology (IRT) system. A separate cohort of 90 new participants were enrolled in the open label portion of the study after completion of enrollment of the blinded portion. None of the participants involved in the blinded portion of the study were included in the open label portion.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04347239
Sponsor's protocol ID: CD12_COVID-19
Status last verified: Sep 2025
First submitted: 13 Apr 2020
Last updated: 15 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Welch J, Dean J, Hartin J. Using NEWS2: an essential component of reliable clinical assessment. Clin Med (Lond). 2022 Nov;22(6):509-513. doi: 10.7861/clinmed.2022-0435.
PubMed 36427875

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04347239
Acronym / sponsor ID: CD12_COVID-19
Conditions: Coronavirus Disease 2019
Keywords: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: CytoDyn, Inc.Industry (pharma, biotech, devices)
Study start: 16 Apr 2020 (actual)
Primary completion: 24 Oct 2021 (actual)
Study completion: 15 Jun 2022 (actual)
First posted: 15 Apr 2020 (actual)
Results: Posted 27 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

A single arm, non-randomized, open-label phase was added to the protocol after completion of enrollment in the randomized phase of the study.

The study had three phases: Screening Period, Treatment Period, and Follow-Up Period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: There were 394 participants randomized to the blinded portion of the study using an Interactive Response Technology (IRT) system. A separate cohort of 90 new participants were enrolled in the open label portion of the study after completion of enrollment of the blinded portion. None of the participants involved in the blinded portion of the study were included in the open label portion.

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSyringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
700mg Leronlimab	Experimental	Drug: Leronlimab (700mg)Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.
700mg Leronlimab Open Label	Experimental	Drug: Leronlimab (700mg)Each vial of active contains 350mg of leronlimab at a concentration of 175mg/ml (nominal 2mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Male or female adult ≥ 18 years of age at time of screening.
Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:
AND
AND
Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:

Key exclusion criteria (9 listed)

Subjects with do-not-resuscitate (DNR) and/or do-not-intubate (DNI) orders or expected to be made DNR/DNI in setting of resource limitations or family wishes.
Not a candidate for dialysis or continuation of care (or full medical support) in setting of resource limitations.
Subject on continuous vasopressors (at the dose of norepinephrine >20μg/min and/or vasopressin >0.04 units/kg/min) for >48 hours at time of screening.
Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
Inability to provide informed consent or to comply with test requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo	Drug	Placebo
Leronlimab (700mg)Also: PRO 140Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)	Drug	700mg Leronlimab, 700mg Leronlimab Open Label

Primary outcome

All-cause Mortality at Day 28
Time frame: Mortality at day 28 (Visit 2, start of treatment = day 0)
Incidence of mortality at day 28

4 secondary outcomes

All-cause Mortality at Day 14
Time frame: Mortality at day 14 (initiation of treatment = day 0)
Proportion of Patients Achieving a Category of 6 or Higher on the Ordinal Scale at Days 14 and 28 (on a 7 Point Ordinal Scale).
Time frame: Change from baseline to days 14 and 28
Change in Clinical Status of Subjects at Day 28 (on a 7 Point Ordinal Scale)
Time frame: Change from start of treatment (baseline) to day 28
Length of Hospital Stay
Time frame: Timeframe is from screening visit to end of treatment (visit 5)

Results and safety

Results posted to the registry on 27 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	129	125
700mg Leronlimab	265	259
700mg Open Label	0	0

Primary outcome: All-cause Mortality at Day 28

Time frame: Mortality at day 28 (Visit 2, start of treatment = day 0). Count of participants. Unit: Participants

Measure	700mg Leronlimab n = 259	Placebo n = 125	700mg Open Label n = 89
Mortality	52	27	23
Survival	207	98	66

Population analysed: Modified Intent to Treat (mITT) population was used for the analysis. The mITT population is defined as the set of subjects who randomized and have received at least one dose of leronlimab (PRO 140) or placebo. This population was used for the primary efficacy endpoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events and medications were monitored throughout the study from Visit 2 (day 0, first treatment) through completion of follow up which is Visit 7, (4 weeks after the End of Treatment visit) for a total of 42 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	47 of 125 (37.6%)	77 of 125 (61.6%)	31 of 125
700mg Leronlimab	99 of 259 (38.2%)	142 of 259 (54.8%)	60 of 259
700mg Open Label	35 of 89 (39.3%)	29 of 89 (32.6%)	23 of 89

Limitations and caveats (from the sponsor): The outcome and safety data came from a report from the contract research organization that oversaw the study. A review of 64 Case Report Forms for the open label portion of the study indicated that over 70% contained no information about adverse events, therefore the adverse events for the open label portion of the study may be underreported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36427875Welch J, Dean J, Hartin J. Using NEWS2: an essential component of reliable clinical assessment. Clin Med (Lond). 2022 Nov;22(6):509-513. doi: 10.7861/clinmed.2022-0435.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacob Lalezari, MD study director

CytoDyn, Inc.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leronlimab (700mg) in people with Coronavirus Disease 2019, run by CytoDyn, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality at Day 28 (time frame: Mortality at day 28 (Visit 2, start of treatment = day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.