Trial Outcomes & Findings for Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 (NCT NCT04347239)
NCT ID: NCT04347239
Last Updated: 2025-10-15
Results Overview
Incidence of mortality at day 28
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
484 participants
Primary outcome timeframe
Mortality at day 28 (Visit 2, start of treatment = day 0)
Results posted on
2025-10-15
Participant Flow
Participants were enrolled at study sites in the United States. First patient was enrolled into Part 1 of the study (blinded portion) on 16-April-2020. Data submitted represent analysis performed on data collected after all patients completed the Follow Up period.
Participant milestones
| Measure |
Placebo
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Leronlimab
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
700mg Open Label
Two syringes each containing 350mg leronlimab
|
|---|---|---|---|
|
Blinded Portion
STARTED
|
129
|
265
|
0
|
|
Blinded Portion
COMPLETED
|
125
|
259
|
0
|
|
Blinded Portion
NOT COMPLETED
|
4
|
6
|
0
|
|
Open Label
STARTED
|
0
|
0
|
90
|
|
Open Label
COMPLETED
|
0
|
0
|
89
|
|
Open Label
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Leronlimab
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
700mg Open Label
Two syringes each containing 350mg leronlimab
|
|---|---|---|---|
|
Blinded Portion
Pt randomized to study but withdrew consent before treatment with investigational product
|
6
|
0
|
4
|
|
Open Label
Pt enrolled but withdrew consent prior to dosing
|
1
|
0
|
0
|
Baseline Characteristics
Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19
Baseline characteristics by cohort
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Leronlimab - open label
n=89 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
171 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Age, Continuous
|
58.82 years
n=5 Participants
|
58.51 years
n=7 Participants
|
59.18 years
n=5 Participants
|
58.72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
257 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
85 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
259 participants
n=5 Participants
|
125 participants
n=7 Participants
|
89 participants
n=5 Participants
|
473 participants
n=4 Participants
|
|
COVID SYMPTOM SCORE
|
3.2 units on a scale
n=5 Participants
|
3.2 units on a scale
n=7 Participants
|
3.3 units on a scale
n=5 Participants
|
3.2 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: Mortality at day 28 (Visit 2, start of treatment = day 0)Population: 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.
Incidence of mortality at day 28
Outcome measures
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
n=89 Participants
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
All-cause Mortality at Day 28
Mortality
|
52 Participants
|
27 Participants
|
23 Participants
|
|
All-cause Mortality at Day 28
Survival
|
207 Participants
|
98 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Mortality at day 14 (initiation of treatment = day 0)Population: 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 secondary outcome endpoint analysis.
Day 0 refers to the data of randomization/first treatment.
Outcome measures
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
n=89 Participants
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
All-cause Mortality at Day 14
|
25 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to days 14 and 28Population: Responders refer to subjects who achieved a category of 6 or higher at Day 14 and/or Day 28. Note: Proportions are based on the result of multiple imputation.
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.
Outcome measures
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
n=89 Participants
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
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).
Responders at d28
|
0.58 Proportion of patients
|
0.55 Proportion of patients
|
0.46 Proportion of patients
|
|
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).
Non-responders at d28
|
0.41 Proportion of patients
|
0.45 Proportion of patients
|
0.47 Proportion of patients
|
|
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).
Missing at d28
|
0 Proportion of patients
|
0 Proportion of patients
|
0.07 Proportion of patients
|
|
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).
Responders at d14
|
0.38 Proportion of patients
|
0.42 Proportion of patients
|
0.39 Proportion of patients
|
|
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).
Non-responders at d14
|
0.62 Proportion of patients
|
0.58 Proportion of patients
|
0.47 Proportion of patients
|
|
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).
Missing at D14
|
0 Proportion of patients
|
0 Proportion of patients
|
0.13 Proportion of patients
|
SECONDARY outcome
Timeframe: Change from start of treatment (baseline) to day 28Population: Rank ANCOVA model adjusted for stratification factor and age based on non-missing observed data. Change from baseline is based on patients with paired values.
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.
Outcome measures
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
n=89 Participants
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
Change in Clinical Status of Subjects at Day 28 (on a 7 Point Ordinal Scale)
|
1.5 score on a scale
Standard Deviation 2.25
|
1.4 score on a scale
Standard Deviation 2.18
|
1.0 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Timeframe is from screening visit to end of treatment (visit 5)Population: 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. Patients with incomplete data were excluded from the analysis. This population was used for the secondary outcome endpoint analysis.
Length of Hospital Stay measured in days
Outcome measures
| Measure |
700mg Leronlimab
n=259 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=125 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
n=74 Participants
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
Length of Hospital Stay
|
15 Days
Interval 1.0 to 45.0
|
14 Days
Interval 1.0 to 46.0
|
14 Days
Interval 1.0 to 45.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mortality at day 14 (initiation of treatment = day 0)Population: There were 62 patients in the critically ill population. Critically ill was defined as patients that were hospitalized, on invasive ventilation or extracorporeal membrane oxygenation (ECMO). Critically ill subjects were a subgroup of the Modified Intent to Treat population used for this analysis. As defined in the SAP, subgroup analysis was performed on predefined stratification factors including the subgroup of patients identified as "critically ill" and defined as above.
All-cause mortality at day 14 in the critically ill population. Day 0 refers to the date of randomization/first treatment.
Outcome measures
| Measure |
700mg Leronlimab
n=43 Participants
Two syringes, each containing 350mg of leronlimab in 2mL, allowed administration of the 700mg dose, subcutaneously.
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
Placebo
n=19 Participants
Two syringes each containing 2mL of normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
|
700mg Open Label
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
All-Cause Mortality at Day 14 in the Critically Ill Population
|
2 Participants
|
5 Participants
|
—
|
Adverse Events
Placebo
Serious events: 47 serious events
Other events: 77 other events
Deaths: 31 deaths
700mg Leronlimab
Serious events: 99 serious events
Other events: 142 other events
Deaths: 60 deaths
700mg Open Label
Serious events: 35 serious events
Other events: 29 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Placebo
n=125 participants at risk
Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
Placebos: Placebo
|
700mg Leronlimab
n=259 participants at risk
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.
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
700mg Open Label
n=89 participants at risk
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
18.4%
23/125 • Number of events 26 • 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.
|
23.6%
61/259 • Number of events 73 • 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.
|
33.7%
30/89 • Number of events 40 • 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.
|
|
Infections and infestations
Infections and Infestations
|
20.0%
25/125 • Number of events 27 • 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.
|
14.7%
38/259 • Number of events 39 • 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.
|
11.2%
10/89 • Number of events 13 • 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.
|
|
Cardiac disorders
Cardiac Disorders
|
9.6%
12/125 • Number of events 12 • 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.
|
8.5%
22/259 • Number of events 26 • 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.
|
7.9%
7/89 • Number of events 10 • 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.
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
9.6%
12/125 • Number of events 12 • 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.
|
6.2%
16/259 • Number of events 16 • 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.
|
4.5%
4/89 • Number of events 4 • 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.
|
|
Investigations
Investigations
|
2.4%
3/125 • Number of events 3 • 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.
|
2.7%
7/259 • Number of events 8 • 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.
|
0.00%
0/89 • 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.
|
|
Nervous system disorders
Nervous System Disorders
|
3.2%
4/125 • Number of events 4 • 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.
|
2.3%
6/259 • Number of events 7 • 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.
|
1.1%
1/89 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition
|
2.4%
3/125 • Number of events 4 • 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.
|
2.3%
6/259 • Number of events 6 • 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.
|
2.2%
2/89 • Number of events 3 • 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.
|
|
General disorders
Gen Disorders and Admin Site Conditions
|
2.4%
3/125 • Number of events 3 • 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.
|
1.9%
5/259 • Number of events 5 • 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.
|
0.00%
0/89 • 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.
|
|
Blood and lymphatic system disorders
Blood and Lymph
|
1.6%
2/125 • Number of events 2 • 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.
|
1.9%
5/259 • Number of events 5 • 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.
|
0.00%
0/89 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
2.4%
3/125 • Number of events 3 • 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.
|
1.5%
4/259 • Number of events 4 • 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.
|
0.00%
0/89 • 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.
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.80%
1/125 • Number of events 1 • 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.
|
1.2%
3/259 • Number of events 4 • 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.
|
0.00%
0/89 • 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.
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/125 • 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.
|
1.5%
4/259 • Number of events 4 • 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.
|
3.4%
3/89 • Number of events 4 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue
|
0.80%
1/125 • Number of events 1 • 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.
|
0.00%
0/259 • 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.
|
0.00%
0/89 • 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
| Measure |
Placebo
n=125 participants at risk
Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
Placebos: Placebo
|
700mg Leronlimab
n=259 participants at risk
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.
Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
|
700mg Open Label
n=89 participants at risk
Two syringes, each containing 350mg leronlimab administered once weekly for 2 weeks.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders
|
26.4%
33/125 • Number of events 46 • 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.
|
29.3%
76/259 • Number of events 104 • 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.
|
14.6%
13/89 • Number of events 18 • 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.
|
|
Infections and infestations
Infections And Infestations
|
27.2%
34/125 • Number of events 53 • 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.
|
23.2%
60/259 • Number of events 85 • 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.
|
13.5%
12/89 • Number of events 20 • 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.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders
|
16.8%
21/125 • Number of events 32 • 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.
|
17.8%
46/259 • Number of events 76 • 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.
|
13.5%
12/89 • Number of events 18 • 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.
|
|
Cardiac disorders
Cardiac Disorders
|
16.8%
21/125 • Number of events 25 • 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.
|
13.9%
36/259 • Number of events 50 • 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.
|
11.2%
10/89 • Number of events 14 • 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.
|
|
Investigations
Investigations
|
18.4%
23/125 • Number of events 28 • 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.
|
10.0%
26/259 • Number of events 43 • 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.
|
1.1%
1/89 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders
|
12.0%
15/125 • Number of events 19 • 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.
|
10.4%
27/259 • Number of events 41 • 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.
|
5.6%
5/89 • Number of events 10 • 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.
|
|
Vascular disorders
Vascular Disorders
|
13.6%
17/125 • Number of events 25 • 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.
|
8.1%
21/259 • Number of events 26 • 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.
|
5.6%
5/89 • Number of events 9 • 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.
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
12.0%
15/125 • Number of events 17 • 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.
|
11.6%
30/259 • Number of events 31 • 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.
|
5.6%
5/89 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
14.4%
18/125 • Number of events 26 • 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.
|
6.6%
17/259 • Number of events 22 • 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.
|
4.5%
4/89 • Number of events 4 • 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.
|
|
Nervous system disorders
Nervous System Disorders
|
11.2%
14/125 • Number of events 17 • 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.
|
5.8%
15/259 • Number of events 22 • 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.
|
2.2%
2/89 • Number of events 5 • 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.
|
|
General disorders
General Disorders And Administration Site Conditions
|
11.2%
14/125 • Number of events 16 • 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.
|
4.6%
12/259 • Number of events 14 • 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.
|
4.5%
4/89 • Number of events 4 • 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.
|
Additional Information
Bernie Cunningham, PhD, MRPharmS; VP Operations
CytoDyn Inc.
Phone: 5164060197
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place