Adults 18 to 99, any sex, with Coronavirus Disease 2019. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in Total Symptom ScorePrimary· Clinical Improvement will be assessed at baseline and at EOT (day 14).
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened.
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \[0=none, 1=mild, 2=moderate, and 3=severe\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.
Group
Value
95% CI
Placebo
-3.4
± 3.19
700mg Leronlimab
-3.5
± 3.03
Time to Clinical Resolution (TTCR)Secondary· Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).
Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough).
Data presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab.
The hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138.
TTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0.
25% subjects
Group
Value
95% CI
Placebo
5
700mg Leronlimab
8
50% subjects
Group
Value
95% CI
Placebo
15
700mg Leronlimab
15
75% subjects
Group
Value
95% CI
Placebo
15
700mg Leronlimab
15
Incidence of HospitalizationSecondary· From visit 2 (day 0) through day 14 (in days)
Number of patients requiring hospitalization
None
Group
Value
95% CI
Placebo
11
700mg Leronlimab
22
1 time
Group
Value
95% CI
Placebo
14
700mg Leronlimab
33
2 times
Group
Value
95% CI
Placebo
3
700mg Leronlimab
1
Duration (Days) of HospitalizationSecondary· Total duration of hospitalization between visit 2 (day 0) in days and end of treatment
Duration of hospitalization in days
Group
Value
95% CI
Placebo
2.0
± 3.19
700mg Leronlimab
2.1
± 3.83
Incidence of Mechanical VentilationSecondary· Total duration of mechanical ventilation since visit 2 (day 0) (days)
Incidence of mechanical ventilation supply
None
Group
Value
95% CI
Placebo
27
700mg Leronlimab
55
1 Time
Group
Value
95% CI
Placebo
1
700mg Leronlimab
1
Duration of Mechanical Ventilation SupplySecondary· Duration of mechanical ventilation since visit 2 (day 0) (days
Duration (days) of mechanical ventilation supply
Group
Value
95% CI
Placebo
0.4
± 1.96
700mg Leronlimab
0.2
± 1.00
Incidence of Oxygen UseSecondary· Use of oxygen since visit 2 (day 0) to end of treatment
Incidence of oxygen use over course of treatment
None
Group
Value
95% CI
Placebo
22
700mg Leronlimab
47
One time
Group
Value
95% CI
Placebo
5
700mg Leronlimab
6
Two times
Group
Value
95% CI
Placebo
1
700mg Leronlimab
2
Three times
Group
Value
95% CI
Placebo
0
700mg Leronlimab
1
Duration of Oxygen UseSecondary· Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)
Duration of oxygen use in days
Group
Value
95% CI
Placebo
0.8
± 2.81
700mg Leronlimab
0.9
± 2.98
Mortality at Day 14Secondary· Mortality at EOT (day 14)
Incidence of mortality at day 14
Group
Value
95% CI
Placebo
0
700mg Leronlimab
0
Time to Return to Normal ActivitySecondary· Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"
Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"
25th percentile pts return to normal
Group
Value
95% CI
Placebo
4.0
700mg Leronlimab
5.0
50th percentile pts return to normal
Group
Value
95% CI
Placebo
8.0
700mg Leronlimab
8.0
75th percentile pts return to normal
Group
Value
95% CI
Placebo
9.0
700mg Leronlimab
15.0
Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14Secondary· Baseline to Day 3, 7 and 14
NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score
Change from Baseline to Day 3
Group
Value
95% CI
Placebo
0.0
± 0.87
700mg Leronlimab
-0.3
± 1.67
Change from Baseline to Day 7
Group
Value
95% CI
Placebo
-0.2
± 1.27
700mg Leronlimab
-0.3
± 2.24
Change from Baseline to Day 14
Group
Value
95% CI
Placebo
-0.2
± 1.06
700mg Leronlimab
-0.4
± 2.42
Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14Secondary· Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14
Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values
Mean change from Baseline to Day 3 of percent oxygen saturation
Group
Value
95% CI
Placebo
0.3
± 1.91
700mg Leronlimab
-0.1
± 2.0
Mean change from Baseline to Day 7 of percent oxygen saturation
Group
Value
95% CI
Placebo
0.4
± 2.08
700mg Leronlimab
0.00
± 2.30
Mean change from Baseline to Day 14 of percent oxygen saturation
Group
Value
95% CI
Placebo
0.6
± 1.73
700mg Leronlimab
0.3
± 2.39
Adverse events — posted to ClinicalTrials.gov
Time frame: Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CytoDyn, Inc.
Last refreshed: 4 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04343651.