Coronavirus Disease 2019
Conditions
Keywords
COVID-19
Brief 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.
Detailed description
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. 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. The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. A total of 75 subjects will be randomized 2:1 in this study.
Interventions
DRUGPlacebo
Placebo
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Sponsors
CytoDyn, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female adult ≥ 18 years of age at time of enrollment. 2. 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\<20, HR \<90, oxygen saturation (pulse oximetry) \> 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 \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND * If available, lung infiltrates based on X-ray or CT scan \< 50% present 3. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. 4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. Understands and agrees to comply with planned study procedures. 6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives \[condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], or intrauterine devices) for the duration of the study.
Exclusion criteria
1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening; 2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy; 3. Subjects showing signs of clinical jaundice at the time of screening; 4. History of moderate and severe liver disease (Child-Pugh score \>12); 5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening; 6. History of severe chronic kidney disease or requiring dialysis; 7. 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. 8. Patients with malignant tumor, or other serious systemic diseases; 9. Patients who are participating in other clinical trials; 10. 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 11. Inability to provide informed consent or to comply with test requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Symptom Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation Supply | Duration of mechanical ventilation since visit 2 (day 0) (days | Duration (days) of mechanical ventilation supply |
| Time to Return to Normal Activity | 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 |
| Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | 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 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score). |
| 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 | Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values |
| Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14) | A 7-category ordinal scale of patient health status ranges 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. Lower scores mean a worse outcome. |
| Time to Clinical Resolution (TTCR) | 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. |
| Incidence of Hospitalization | From visit 2 (day 0) through day 14 (in days) | Number of patients requiring hospitalization |
| Duration (Days) of Hospitalization | Total duration of hospitalization between visit 2 (day 0) in days and end of treatment | Duration of hospitalization in days |
| Incidence of Mechanical Ventilation | Total duration of mechanical ventilation since visit 2 (day 0) (days) | Incidence of mechanical ventilation supply |
| Incidence of Oxygen Use | Use of oxygen since visit 2 (day 0) to end of treatment | Incidence of oxygen use over course of treatment |
| Duration of Oxygen Use | Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days) | Duration of oxygen use in days |
| Mortality at Day 14 | Mortality at EOT (day 14) | Incidence of mortality at day 14 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages | Days 3, 7, and 14 | Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14 |
| Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count | Days 3, 7, and 14 | Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14 |
| Change in Size of Lesion Area by Chest Radiograph or CT | Day 14 | Change in size of lesion area by chest radiograph or CT - exploratory endpoint |
| Change From Baseline in Serum Cytokine and Chemokine Levels | Days 3, 7, and 14 | Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States. The first participant was randomized on 30-Apr-2020. Data submitted represent analysis performed on data collected after all patients completed the Follow UP period.
Pre-assignment details
126 patients were screened, 40 were screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebos: Placebo
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment 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\<20, HR \<90, oxygen saturation (pulse oximetry) \> 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 \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. | 28 |
| 700mg Leronlimab Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.
Male or female adult ≥ 18 years of age at time of enrollment 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\<20, HR \<90, oxygen saturation (pulse oximetry) \> 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 \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
* If available, lung infiltrates based on X-ray or CT scan \< 50% present
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. | 56 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Did not start treatment | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Missing | 3 | 9 |
| Overall Study | Patient did not complete visits 3-6 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Placebo | 700mg Leronlimab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 14 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 42 Participants | 63 Participants |
| Age, Continuous | 55.36 years | 54.59 years | 54.85 years |
| COVID SYMPTOMS SCORE Baseline symptom score greater than 4 | 12 Participants | 27 Participants | 39 Participants |
| COVID SYMPTOMS SCORE Baseline symptom score less than or equal to 4 | 16 Participants | 29 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 18 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 35 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 28 participants | 56 participants | 84 participants |
| Sex: Female, Male Female | 19 Participants | 32 Participants | 51 Participants |
| Sex: Female, Male Male | 9 Participants | 24 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 1 / 56 |
| other Total, other adverse events | 12 / 28 | 7 / 56 |
| serious Total, serious adverse events | 6 / 28 | 5 / 56 |
Outcome results
Primary
Mean Change From Baseline in Total Symptom Score
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.
Time frame: Clinical Improvement will be assessed at baseline and at EOT (day 14).
Population: The Modified Intent-to-Treat (mITT) population was defined as the set of subjects who received at least one dose of leronlimab (PRO 140) or placebo. This population was to be used for the analysis of efficacy parameters or measurements. At the time of this report, there were 84 subjects in the mITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Symptom Score | -3.4 units on a scale | Standard Deviation 3.19 |
| 700mg Leronlimab | Mean Change From Baseline in Total Symptom Score | -3.5 units on a scale | Standard Deviation 3.03 |
p-value: 0.818ANCOVA
Secondary
Change From Baseline in National Early Warning Score 2 (NEWS2) 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 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score).
Time frame: Baseline to Day 3, 7 and 14
Population: MITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 3 | 0.0 score on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 7 | -0.2 score on a scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 14 | -0.2 score on a scale | Standard Deviation 1.06 |
| 700mg Leronlimab | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 3 | -0.3 score on a scale | Standard Deviation 1.67 |
| 700mg Leronlimab | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 7 | -0.3 score on a scale | Standard Deviation 2.24 |
| 700mg Leronlimab | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | Change from Baseline to Day 14 | -0.4 score on a scale | Standard Deviation 2.42 |
Secondary
Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14
A 7-category ordinal scale of patient health status ranges 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. Lower scores mean a worse outcome.
Time frame: Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14)
Population: MITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 3 | 0.4 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 7 | 1.1 units on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 14 | 1.2 units on a scale | Standard Deviation 0.75 |
| 700mg Leronlimab | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 3 | 0.5 units on a scale | Standard Deviation 0.75 |
| 700mg Leronlimab | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 7 | 0.7 units on a scale | Standard Deviation 0.99 |
| 700mg Leronlimab | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14 | Mean change from baseline at day 14 | 1.0 units on a scale | Standard Deviation 1.13 |
Secondary
Duration (Days) of Hospitalization
Duration of hospitalization in days
Time frame: Total duration of hospitalization between visit 2 (day 0) in days and end of treatment
Population: MITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration (Days) of Hospitalization | 2.0 days | Standard Deviation 3.19 |
| 700mg Leronlimab | Duration (Days) of Hospitalization | 2.1 days | Standard Deviation 3.83 |
Secondary
Duration of Mechanical Ventilation Supply
Duration (days) of mechanical ventilation supply
Time frame: Duration of mechanical ventilation since visit 2 (day 0) (days
Population: MITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Mechanical Ventilation Supply | 0.4 days | Standard Deviation 1.96 |
| 700mg Leronlimab | Duration of Mechanical Ventilation Supply | 0.2 days | Standard Deviation 1 |
Secondary
Duration of Oxygen Use
Duration of oxygen use in days
Time frame: Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)
Population: MITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Oxygen Use | 0.8 days | Standard Deviation 2.81 |
| 700mg Leronlimab | Duration of Oxygen Use | 0.9 days | Standard Deviation 2.98 |
Secondary
Incidence of Hospitalization
Number of patients requiring hospitalization
Time frame: From visit 2 (day 0) through day 14 (in days)
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incidence of Hospitalization | None | 11 participants |
| Placebo | Incidence of Hospitalization | 1 time | 14 participants |
| Placebo | Incidence of Hospitalization | 2 times | 3 participants |
| 700mg Leronlimab | Incidence of Hospitalization | None | 22 participants |
| 700mg Leronlimab | Incidence of Hospitalization | 1 time | 33 participants |
| 700mg Leronlimab | Incidence of Hospitalization | 2 times | 1 participants |
Secondary
Incidence of Mechanical Ventilation
Incidence of mechanical ventilation supply
Time frame: Total duration of mechanical ventilation since visit 2 (day 0) (days)
Population: MITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Incidence of Mechanical Ventilation | None | 27 Participants |
| Placebo | Incidence of Mechanical Ventilation | 1 Time | 1 Participants |
| 700mg Leronlimab | Incidence of Mechanical Ventilation | None | 55 Participants |
| 700mg Leronlimab | Incidence of Mechanical Ventilation | 1 Time | 1 Participants |
Secondary
Incidence of Oxygen Use
Incidence of oxygen use over course of treatment
Time frame: Use of oxygen since visit 2 (day 0) to end of treatment
Population: MITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Incidence of Oxygen Use | None | 22 Participants |
| Placebo | Incidence of Oxygen Use | One time | 5 Participants |
| Placebo | Incidence of Oxygen Use | Two times | 1 Participants |
| Placebo | Incidence of Oxygen Use | Three times | 0 Participants |
| 700mg Leronlimab | Incidence of Oxygen Use | Three times | 1 Participants |
| 700mg Leronlimab | Incidence of Oxygen Use | None | 47 Participants |
| 700mg Leronlimab | Incidence of Oxygen Use | Two times | 2 Participants |
| 700mg Leronlimab | Incidence of Oxygen Use | One time | 6 Participants |
Secondary
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
Time frame: Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14
Population: MITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 3 of percent oxygen saturation | 0.3 Mean change in % O2 sat | Standard Deviation 1.91 |
| Placebo | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 7 of percent oxygen saturation | 0.4 Mean change in % O2 sat | Standard Deviation 2.08 |
| Placebo | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 14 of percent oxygen saturation | 0.6 Mean change in % O2 sat | Standard Deviation 1.73 |
| 700mg Leronlimab | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 3 of percent oxygen saturation | -0.1 Mean change in % O2 sat | Standard Deviation 2 |
| 700mg Leronlimab | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 7 of percent oxygen saturation | 0.00 Mean change in % O2 sat | Standard Deviation 2.3 |
| 700mg Leronlimab | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change from Baseline to Day 14 of percent oxygen saturation | 0.3 Mean change in % O2 sat | Standard Deviation 2.39 |
Secondary
Mortality at Day 14
Incidence of mortality at day 14
Time frame: Mortality at EOT (day 14)
Population: MITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Mortality at Day 14 | 0 Participants |
| 700mg Leronlimab | Mortality at Day 14 | 0 Participants |
Secondary
Time to Clinical Resolution (TTCR)
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.
Time frame: Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to Clinical Resolution (TTCR) | 50% subjects | 15 days |
| Placebo | Time to Clinical Resolution (TTCR) | 75% subjects | 15 days |
| Placebo | Time to Clinical Resolution (TTCR) | 25% subjects | 5 days |
| 700mg Leronlimab | Time to Clinical Resolution (TTCR) | 25% subjects | 8 days |
| 700mg Leronlimab | Time to Clinical Resolution (TTCR) | 50% subjects | 15 days |
| 700mg Leronlimab | Time to Clinical Resolution (TTCR) | 75% subjects | 15 days |
p-value: 0.413895% CI: [0.43, 1.41]Likelihood test-Cox Prop. hazards model
Secondary
Time to Return to Normal Activity
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
Time frame: Date of first exposure to treatment to the first occurrence of ordinal scale equals not hospitalized, no limitations of activities
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to Return to Normal Activity | 25th percentile pts return to normal | 4.0 days |
| Placebo | Time to Return to Normal Activity | 50th percentile pts return to normal | 8.0 days |
| Placebo | Time to Return to Normal Activity | 75th percentile pts return to normal | 9.0 days |
| 700mg Leronlimab | Time to Return to Normal Activity | 75th percentile pts return to normal | 15.0 days |
| 700mg Leronlimab | Time to Return to Normal Activity | 25th percentile pts return to normal | 5.0 days |
| 700mg Leronlimab | Time to Return to Normal Activity | 50th percentile pts return to normal | 8.0 days |
Other Pre-specified
Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages
Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14
Time frame: Days 3, 7, and 14
Other Pre-specified
Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count
Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14
Time frame: Days 3, 7, and 14
Other Pre-specified
Change From Baseline in Serum Cytokine and Chemokine Levels
Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14
Time frame: Days 3, 7, and 14
Other Pre-specified
Change in Size of Lesion Area by Chest Radiograph or CT
Change in size of lesion area by chest radiograph or CT - exploratory endpoint
Time frame: Day 14