Phase 2
Completed N=86
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Source: ClinicalTrials.gov NCT04343651 ↗Enrolled (actual)
86
Serious AEs
13.1%
Results posted
Jan 2023
Primary outcomePrimary: Mean Change From Baseline in Total Symptom Score — -3.4; -3.5 units on a scale — p=0.818
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Symptom Score |
-3.4; -3.5 | 0.818 |
| SECONDARY Time to Clinical Resolution (TTCR) |
5; 8; 15; 15; 15; 15 | 0.4138 |
| SECONDARY Incidence of Hospitalization |
11; 22; 14; 33; 3; 1 | — |
| SECONDARY Duration (Days) of Hospitalization |
2.0; 2.1 | — |
| SECONDARY Incidence of Mechanical Ventilation |
27; 55; 1; 1 | — |
| SECONDARY Duration of Mechanical Ventilation Supply |
0.4; 0.2 | — |
| SECONDARY Incidence of Oxygen Use |
22; 47; 5; 6; 1; 2 | — |
| SECONDARY Duration of Oxygen Use |
0.8; 0.9 | — |
| SECONDARY Mortality at Day 14 |
0; 0 | — |
| SECONDARY Time to Return to Normal Activity |
4.0; 5.0; 8.0; 8.0; 9.0; 15.0 | — |
| SECONDARY Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 |
0.0; -0.3; -0.2; -0.3; -0.2; -0.4 | — |
| SECONDARY Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 |
0.3; -0.1; 0.4; 0.00; 0.6; 0.3 | — |
| SECONDARY Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 |
0.4; 0.5; 1.1; 0.7; 1.2; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adult ≥ 18 years of age at time of enrollment.
- Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
- Diagnosed with COVID-19 by a standardized RT-PCR assay AND
- Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
- No signs of a more serious lower airway disease AND
- RR 93% on room air
Moderate Illness:
- Diagnosed with COVID-19 by a standardized RT-PCR assay AND
- In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
- Signs of moderate pneumonia, including RR ≥ 20 but 93% on room air AND
- If available, lung infiltrates based on X-ray or CT scan 12);
- Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;
- History of severe chronic kidney disease or requiring dialysis;
- Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months.
Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study.
- Patients with malignant tumor, or other serious systemic diseases;
- Patients who are participating in other clinical trials;
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible; and
- Inability to provide informed consent or to comply with test requirements
Data sourced from ClinicalTrials.gov (NCT04343651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.