Coronavirus Disease 2019
Conditions
Keywords
COVID-19
Brief summary
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injections in subjects experiencing prolonged symptoms (\> 12 weeks) of COVID-19.
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 prolonged symptoms caused by Coronavirus Disease 2019 (COVID-19). 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. Total study duration is 91 days. The study will be conducted at up to 5 centers in the United States and planned number of subjects are 50 subjects. Visit schedule: Visit 1 - Screening assessment Visit 2 - baseline, first dose Visit 3 - no dose, baseline+3 days Visit 4 - second dose, baseline + 7 days Visit 5 - no dose, safety assessment/con med, baseline +10 days Visit 6 - third dose, baselines + 14 days Visit 7 - no dose, safety assessments, baseline + 17 days Visit 8 - fourth dose, baseline +21 days Visit 9 - no dose, safety assessment, baseline + 24 days Visit 10 - fifth dose, baseline + 28 days Visit 11 - no dose, safety assessment, baseline + 31 days Visit 12 - sixth dose, baseline + 35 days Visit 13 - no dose, safety assessment, baseline + 38 days Visit 14 - seventh dose, baseline + 42 days Visit 15 - no dose, safety assessment, baseline + 45 days Visit 16 - eighth and final dose, baseline + 49 days Visit 17 - End of treatment, baseline + 56 days
Interventions
DRUGPlacebos
Placebos
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Sponsors
Amarex Clinical Research
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adult ≥ 18 years of age at time of enrollment. 2. Prior confirmed COVID-19 diagnosis by standard reverse transcriptase-polymerase chain reaction (RT-PCR) assay or equivalent testing 3. Clinical Symptom Score of ≥6 AND at least two symptoms of moderate or higher severity as listed below at the time of Screening and currently experiencing two or more of the following symptoms consistent with COVID-19 infection for a prolonged period of time (\>12 weeks). Clinical symptoms include the following: * Respiratory symptoms such as cough, sore throat, stuffy or runny nose, shortness of breath (difficulty breathing), tightness of chest. * Neurological symptoms such as difficulty in concentration (brain fog), sleep disturbance/insomnia, headache, dizziness, anxiety, tingling or numbness, loss of sense of smell or taste. * Cardiovascular and Gastrointestinal symptoms such as feeling of fast heartbeat, nausea, vomiting, diarrhea. * Musculoskeletal symptoms such as muscle aches/cramps, muscle weakness, joint pain/swelling. * General immune response symptoms such as fatigue (low energy or tiredness), chills or shivering, feeling hot or feverish, or exertional malaise (feeling of discomfort, illness, or lack of well-being after physical activity or mental stress). Note: Clinical Symptom Score is obtained from the patient diary (refer to Appendix 1 for scoring instructions). 4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator. Note: Below are the examples of clinically significant and non-clinically significant ECG abnormalities: * ECG findings indicative of acute myocardial infarction or acute ischemic changes would be considered clinically significant abnormalities. * ECG finding such as atrial fibrillation, atrial flutter, paced rhythms in individuals who have undergone permanent pacemaker placement, evidence of prior infarction, unchanged stable conduction abnormalities e.g. right bundle branch block, or any other finding which does not significantly impact mortality would be considered non-clinically significant findings and subjects with these abnormal findings would be allowed to enroll in the study. 5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 6. Men and women of childbearing potential and their partner must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], or one of the following methods of birth control (intrauterine devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual abstinence for the duration of the study (excluding women who are not of childbearing potential and men who have been sterilized). 7. Females of child-bearing potential must have a negative urine pregnancy test at Screening Visit and prior to receiving the first dose of study drug; and Male participants must agree to use contraception and refrain from donating sperm for at least 90 days after the last dose of study intervention. 8. Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions
Exclusion criteria
1. Exhibiting signs of moderate or severe pulmonary disease (such as Chronic Obstructive Pulmonary Disease (COPD), asthma, or pulmonary fibrosis) 2. Ongoing requirement of oxygen therapy 3. Pulse oxygen saturation (SpO2) of \<94% on room air at the time of screening 4. History of splenectomy 5. Liver cirrhosis or patient showing signs of clinical jaundice at the time of screening 6. Chronic kidney disease stage 4 or requiring dialysis at the time of screening 7. New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) 8. Exhibiting signs of uncontrolled hypo-or hyper- thyroidism at the time of Screening 9. Uncontrolled rheumatologic disorders at the time of screening 10. History of organ transplantation or are candidates for organ transplantation at the time of screening 11. History of Chronic Fatigue Syndrome prior to COVID-19 infection 12. History of fibromyalgia prior to COVID-19 infection 13. History of major psychiatric disorder including bipolar disorders, schizophrenia, schizoaffective disorder, major depression. Patients with major depression can be enrolled if patient has had no episode within the past year or is considered in remission or controlled by treatment. 14. Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. 15. Any other clinically significant serious systemic diseases which would interfere with study conduct or study results interpretation per the Investigator. 16. Treatment with immunosuppressive or immunomodulatory medications within 5 half-lives prior to screening. Patients on replacement therapy for adrenal insufficiency will be allowed. Patients on stable (\> 3 months) low dose corticosteroid ≤ 5 mg Prednisone will be allowed. 17. History of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible 18. Ongoing use of CCR5 antagonist 19. Inability to provide informed consent or to comply with test requirements 20. Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment 21. Pregnancy or breast feeding 22. Participating in another study for an investigational treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56. | Changes in COVID-19 related symptoms from baseline (start of treatment) and day 56 (end of treatment) | Changes in common COVID-19-related symptoms were evaluated daily by the patient using a patient diary between start and end of treatment. The diary is shown in Appendix 17.1 in the protocol and covers patient-reported changes for symptoms (ranked as none = 0, mild = 1, moderate = 2 or severe = 3) of cough, sore throat, stuffy or runny nose, difficulty breathing, feeling tightness in chest, feeling fast heartbeat, fatigue, exertional malaise, muscle aches and cramps, muscle weakness, joint pain and swelling, shivering and chills, feeling hot or feverish, difficulty concentrating, insomnia, headache, dizziness, anxiety, tingling or numbness, nausea, vomiting, diarrhea, sense of smell, sense of taste. Maximum score could be 70 (22 parameters with scores up to 3, two parameters with scores up to 2), lowest score could be 0. A negative value shows improvement in symptoms. The lower the value, the greater the improvement (i.e., a score of -16 is greater improvement than a score of -8). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Between start of treatment (day0) and day 56 (end of treatment) | Symptom-free days are defined as number of days when any symptoms scored as mild, moderate or severe at baseline are scored as absent (or none) through Day 56 (end of treatment) using a self-assessment diary. |
| Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Between start of treatment (day0) and day 56 (end of treatment) | Progression or worsening of symptoms is defined as number of days when any symptoms scored as 2 at baseline scored as 3 through day 56 or 1 at baseline are scored as 2 or 3 through day 56 or scored 0 at study entry scored as 1, 2 or 3 through day 56. No change in symptoms would give a score of 0, symptom progression would give a positive number, symptom improvement would a negative number. Minimum baseline symptom score for eligibility for the study was 6. Maximum symptom score is 70, therefore if all symptoms progressed to the severest level the change in score would be +64. If all patients had a severe score for all symptoms at baseline and all improved to no symptoms at day 56, the maximum improvement in score would be -70. |
| Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Between Baseline (day 0), Visit 4 (day 7), Visit 6 (day 14), Visit 8 (day 21) Visit 10 (day 28), Visit 12 (day 35), Visit 14 (day 42), Visit 16 (Day 56) and Visit 17 (day 56, end of treatment). | Change from baseline in physical and psychological fatigue measured using the PROMIS® scale. A decrease in the score compared to baseline shows an improvement in the symptom. PROMIS definition - Patient-Reported Outcomes Measurement Information System. The Fatigue Short Form (4a) was used (Section 17.3 Appendix 3 of protocol). Raw fatigue scores range from 4 to 20 and are converted to a T-score metric where the response from the general population is set at 50 with standard deviations at 10; a score of greater than 60 would be one std dev greater than the general population, meaning more fatigue. A link to the fatigue score maps is provided in the hyperlinks section. The minimum fatigue T-score is 33.7 (with a std error of 4.9) and a maximum score of 75.8 (with a std error of 3.9). The higher the score, the more fatigue. A decrease in the fatigue score from baseline to day 28 and day 56 would indicate decrease in fatigue. |
| Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration of symptoms from baseline (day 0, start of treatment) and day 56 (end of treatment) | Number of days when any symptoms scored as moderate or severe at baseline (Day 0) are still scored as moderate or severe through day 56 (end of treatment) or symptoms scored as mild or absent at baseline are scored as mild or worse at day 56 (end of treatment). |
| Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Between Baseline (day 0), Visit 4 (day 7), Visit 6 (day 14), Visit 8 (day 21) Visit 10 (day 28), Visit 12 (day 35), Visit 14 (day 42), Visit 16 (Day 56) and Visit 17 (day 56, end of treatment). | Assessment of change in sleep disturbance between baseline, day 28 and day 56 used the PROMIS® Sleep Disturbance Short Form (see Appendix 5 in Section 17 of the protocol). Four questions are scored between 1 (best score for good quality sleep) and 5 (worst score) such that the lower the score, the better the sleep. Raw scores are converted to a T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population. T-scores of 60 are one SD worse than average (worse quality sleep). By comparison, Sleep Disturbance T-scores of 40 are one SD better than average. The PROMIS Sleep Disturbance scoring manual shows the lowest sleep disturbance score of 4 converting to a T score of 32 with a std error of 5.2, while the highest score of 20 converts to a T score of 73.3 with a std error of 4.6. The change from baseline is based on patients with paired values. |
| Number of Participants Requiring Hospitalization During the Treatment Phase | Between baseline (start of treatment) and day 56 (end of treatment) | Number of participants who required hospitalization during the treatment phase. |
| Duration (Days) of Hospitalization During the Treatment Phase | Between baseline (start of treatment) and day 56 (end of treatment) | Duration (in days) of hospitalization required during treatment phase |
| Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Baseline (start of treatment), day 28 and day 56 (end of treatment) | Change in cognitive function score between baseline, day 28 and day 56 were measured using the PROMIS Cognitive Function Assessment Short Form 4a. Higher scores on the PROMIS Cognitive Function Assessment indicate better perceived cognitive functioning. Answers to 4 questions with scores ranging from 1 (very often - several times a day) to 5 (never) provide raw scores that are then normalized T scores. A T score of 50 is the mean of the general population, with std devs of 10, therefore a score of 40 is one std dev lower than that of the general population. The lowest raw score (4) converts to a T score of 24.99 while the highest raw score (20) converts to a T score of 61.13. A link to the PROMIS scoring maps is provided in the hyperlinks section. An increase in score for cognitive function assessment represents an increase in cognitive function |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-related Adverse Events (TEAEs) | Between baseline and day 91 | Safety Measurement - incidence of treatment emergent adverse events |
| Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) | Between baseline and day 91 | Safety Measures - Incidence and severity of treatment-emergent adverse events |
| Incidence of Serious Adverse Events (SAEs) | Between baseline and day 91 | Safety Measures - incidence of severe adverse events |
| Changes in Electrocardiogram (ECG) Results | Change between baseline and day 91 | Safety Measures - changes in electrocardiogram results |
| Changes in Blood Chemistry, Hematology and Coagulation Parameter Results | Between baseline and day 91 | Safety Measures - Changes in blood chemistry, hematology and coagulation parameter results |
| Changes in Physical Examination Results | Between baseline and day 91 | Safety Measures - Changes in physical examination results |
| Incidence of TEAEs and SAEs Leading to Discontinuation of Study Medication. | Between baseline and day 56 | Safety Measures - incidence of TEAEs and SAEs leading to discontinuation of study medication |
| Changes in Vital Signs Including Temperature, Pulse, Respiratory Rate, Systolic and Diastolic Blood Pressure | Between baseline and day 91 | Safety Measures - Changes in vital signs including temperature, pulse, respiratory rate, systolic and diastolic blood pressure |
| Change From Baseline in Pulse Oxygen Saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, and 56 | Change between baseline (start of treatment) and Day 7, 14, 21, 28, 35, 42, 49, and 56 (end of treatment). | Exploratory Outcome - Change from baseline in pulse oxygen saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, and 56 |
| Change From Baseline in Serum Cytokine and Chemokine Levels on Days 28 and 56. | Change between baseline (start of treatment) and days 28 and 56 (end of treatment) | Exploratory Outcome - Change from baseline in serum cytokine and chemokine levels |
| Change From Baseline in CD4+ and CD8+ T Cell Count on Days 28 and 56. | Change between baseline (start of treatment) and days 28 and 56 (end of treatment) | Exploratory Outcome - Change from baseline in CD4+ and CD8+ T cell count |
| Change From Baseline in Transforming Growth Factor Beta 1 (TGF beta1) on Days 28 and 56 | Change between baseline (start of treatment) and days 28 and 56 (end of treatment) | Exploratory Outcome - change in TGF-b1 from baseline to days 28 and 56 (end of treatment) |
| Change From Baseline in C-reactive Protein (CRP) on Days 28 and 56 | Change between baseline (start of treatment) and days 28 and 56 (end of treatment) | Exploratory Outcome - Change in C-reactive Protein (CRP) from baseline to Days 28 and 56 (end of treatment) |
| Change From Baseline in CCR5 Receptor Occupancy on Days 28 and 56. | Change between baseline (start of treatment) and days 28 and 56 (end of treatment) | Exploratory Outcome - Change in CCR5 receptor occupancy from baseline and days 28 and 56 (end of treatment) |
| Exploration of Biomarkers That May Predict and/or Act as Pharmacodynamic Indicators of Pharmacologic Activity of Leronlimab. | 91 Days | Exploratory Outcome - Exploration of biomarkers that may predict and/or act as pharmacodynamic indicators of pharmacologic activity of leronlimab. |
Countries
United States
Participant flow
Recruitment details
Fifty six (56) subjects were enrolled in the study with 28 subjects in each treatment arm. All patients were enrolled under protocol version 3.0 (effective date 25-Feb-2021). The study was performed between 01 March 2021 and 01 July 2021.
Participants by arm
| Arm | Count |
|---|---|
| 700mg Leronlimab 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) | 28 |
| Placebo Syringes containing normal saline for injection were prepared by an unblinded pharmacist at the clinical sites for use as the placebo.
Placebos: Placebos | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 700mg Leronlimab | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 23 Participants | 49 Participants |
| Age, Continuous | 45.5 years STANDARD_DEVIATION 12.8 | 51.6 years STANDARD_DEVIATION 13.2 | 48.6 years STANDARD_DEVIATION 13.24 |
| Baseline COVID-19 Related Symptom Score | 32.5 units on a scale STANDARD_DEVIATION 9.96 | 26.9 units on a scale STANDARD_DEVIATION 10.19 | 29.4 units on a scale STANDARD_DEVIATION 10.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 27 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 27 Participants | 55 Participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 22 / 28 | 20 / 28 |
| serious Total, serious adverse events | 0 / 28 | 1 / 28 |
Outcome results
Primary
Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56.
Changes in common COVID-19-related symptoms were evaluated daily by the patient using a patient diary between start and end of treatment. The diary is shown in Appendix 17.1 in the protocol and covers patient-reported changes for symptoms (ranked as none = 0, mild = 1, moderate = 2 or severe = 3) of cough, sore throat, stuffy or runny nose, difficulty breathing, feeling tightness in chest, feeling fast heartbeat, fatigue, exertional malaise, muscle aches and cramps, muscle weakness, joint pain and swelling, shivering and chills, feeling hot or feverish, difficulty concentrating, insomnia, headache, dizziness, anxiety, tingling or numbness, nausea, vomiting, diarrhea, sense of smell, sense of taste. Maximum score could be 70 (22 parameters with scores up to 3, two parameters with scores up to 2), lowest score could be 0. A negative value shows improvement in symptoms. The lower the value, the greater the improvement (i.e., a score of -16 is greater improvement than a score of -8).
Time frame: Changes in COVID-19 related symptoms from baseline (start of treatment) and day 56 (end of treatment)
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. Fifty six (56) patients received at least one dose of leronlimab or placebo.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 700mg Leronlimab | Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56. | -16.3 units on a scale | Standard Deviation 13.14 |
| Placebo | Changes From Baseline in Daily COVID-19-related Symptom Severity Score Through Day 56. | -8.1 units on a scale | Standard Deviation 12.27 |
Secondary
Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56)
Change in cognitive function score between baseline, day 28 and day 56 were measured using the PROMIS Cognitive Function Assessment Short Form 4a. Higher scores on the PROMIS Cognitive Function Assessment indicate better perceived cognitive functioning. Answers to 4 questions with scores ranging from 1 (very often - several times a day) to 5 (never) provide raw scores that are then normalized T scores. A T score of 50 is the mean of the general population, with std devs of 10, therefore a score of 40 is one std dev lower than that of the general population. The lowest raw score (4) converts to a T score of 24.99 while the highest raw score (20) converts to a T score of 61.13. A link to the PROMIS scoring maps is provided in the hyperlinks section. An increase in score for cognitive function assessment represents an increase in cognitive function
Time frame: Baseline (start of treatment), day 28 and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 4 (day 7) | 5.1 units on a scale | Standard Deviation 8.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 12 (day 35) | 10.1 units on a scale | Standard Deviation 9.4 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 8 (day 21) | 7.4 units on a scale | Standard Deviation 10 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 14 (day 42) | 10.8 units on a scale | Standard Deviation 11.2 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 6 (day 14) | 7.4 units on a scale | Standard Deviation 9.6 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 16 (day 49) | 10.3 units on a scale | Standard Deviation 10.8 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 10 (day 28) | 9.0 units on a scale | Standard Deviation 8.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to end of treatment (day 56) | 10.9 units on a scale | Standard Deviation 10.8 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Baseline (day 0) | 29.6 units on a scale | Standard Deviation 5.5 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to end of treatment (day 56) | 6.3 units on a scale | Standard Deviation 8.8 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Baseline (day 0) | 34.6 units on a scale | Standard Deviation 9.5 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 4 (day 7) | 2.7 units on a scale | Standard Deviation 8.2 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 6 (day 14) | 4.9 units on a scale | Standard Deviation 9.5 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 8 (day 21) | 4.6 units on a scale | Standard Deviation 7.9 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 10 (day 28) | 4.1 units on a scale | Standard Deviation 8 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 12 (day 35) | 6.2 units on a scale | Standard Deviation 9.1 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 14 (day 42) | 6.2 units on a scale | Standard Deviation 8.6 |
| Placebo | Change From Baseline in PROMIS® Cognitive Function Score at Days 7, 14, 21, 28, 35, 42, 49 and End of Treatment (d56) | Change from baseline to visit 16 (day 49) | 7.4 units on a scale | Standard Deviation 9.7 |
Secondary
Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56).
Change from baseline in physical and psychological fatigue measured using the PROMIS® scale. A decrease in the score compared to baseline shows an improvement in the symptom. PROMIS definition - Patient-Reported Outcomes Measurement Information System. The Fatigue Short Form (4a) was used (Section 17.3 Appendix 3 of protocol). Raw fatigue scores range from 4 to 20 and are converted to a T-score metric where the response from the general population is set at 50 with standard deviations at 10; a score of greater than 60 would be one std dev greater than the general population, meaning more fatigue. A link to the fatigue score maps is provided in the hyperlinks section. The minimum fatigue T-score is 33.7 (with a std error of 4.9) and a maximum score of 75.8 (with a std error of 3.9). The higher the score, the more fatigue. A decrease in the fatigue score from baseline to day 28 and day 56 would indicate decrease in fatigue.
Time frame: Between Baseline (day 0), Visit 4 (day 7), Visit 6 (day 14), Visit 8 (day 21) Visit 10 (day 28), Visit 12 (day 35), Visit 14 (day 42), Visit 16 (Day 56) and Visit 17 (day 56, end of treatment).
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 4 (day 7) | -5.3 Units on a scale | Standard Deviation 9.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to Visit 12 (day 25) | -11.1 Units on a scale | Standard Deviation 13.4 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 8 (day 21) | -8.4 Units on a scale | Standard Deviation 14.6 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 14 (day 42) | -11.0 Units on a scale | Standard Deviation 14 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 6 (day 14) | -7.6 Units on a scale | Standard Deviation 10.7 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | change from baseline to visit 16 (day 49) | -11.8 Units on a scale | Standard Deviation 12.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 10 (day 28) | -8.8 Units on a scale | Standard Deviation 12.1 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to end of treatment (day 56) | -11.1 Units on a scale | Standard Deviation 11.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Baseline score (day 0) | 68.4 Units on a scale | Standard Deviation 6.5 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to end of treatment (day 56) | -10.2 Units on a scale | Standard Deviation 10.8 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Baseline score (day 0) | 66.6 Units on a scale | Standard Deviation 7.1 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 4 (day 7) | -6.1 Units on a scale | Standard Deviation 8.5 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 6 (day 14) | -7.6 Units on a scale | Standard Deviation 8.5 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 8 (day 21) | -10.2 Units on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 10 (day 28) | -7.5 Units on a scale | Standard Deviation 10.5 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to Visit 12 (day 25) | -8.6 Units on a scale | Standard Deviation 10.8 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | Change from baseline to visit 14 (day 42) | -8.1 Units on a scale | Standard Deviation 11.2 |
| Placebo | Change From Baseline in PROMIS® Fatigue Score at Days 7,14, 21, 28, 35, 42 and End of Treatment (Day 56). | change from baseline to visit 16 (day 49) | -11.0 Units on a scale | Standard Deviation 11.5 |
Secondary
Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56).
Assessment of change in sleep disturbance between baseline, day 28 and day 56 used the PROMIS® Sleep Disturbance Short Form (see Appendix 5 in Section 17 of the protocol). Four questions are scored between 1 (best score for good quality sleep) and 5 (worst score) such that the lower the score, the better the sleep. Raw scores are converted to a T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population. T-scores of 60 are one SD worse than average (worse quality sleep). By comparison, Sleep Disturbance T-scores of 40 are one SD better than average. The PROMIS Sleep Disturbance scoring manual shows the lowest sleep disturbance score of 4 converting to a T score of 32 with a std error of 5.2, while the highest score of 20 converts to a T score of 73.3 with a std error of 4.6. The change from baseline is based on patients with paired values.
Time frame: Between Baseline (day 0), Visit 4 (day 7), Visit 6 (day 14), Visit 8 (day 21) Visit 10 (day 28), Visit 12 (day 35), Visit 14 (day 42), Visit 16 (Day 56) and Visit 17 (day 56, end of treatment).
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 4 (day 7) | -4.1 score on a scale | Standard Deviation 8.6 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 12 (day 35) | -8.3 score on a scale | Standard Deviation 10.8 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline visit 8 (day 21) | -7.7 score on a scale | Standard Deviation 10.2 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 14 (day 42) | -7.7 score on a scale | Standard Deviation 10.7 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 6 (day 14) | -5.3 score on a scale | Standard Deviation 9.6 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 16 (day 49) | -7.6 score on a scale | Standard Deviation 9.5 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 10 (day 28) | -7.2 score on a scale | Standard Deviation 8.9 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to end of treatment (day 56) | -8.3 score on a scale | Standard Deviation 9.4 |
| 700mg Leronlimab | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Baseline score (day 0) | 60.2 score on a scale | Standard Deviation 8 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to end of treatment (day 56) | -5.5 score on a scale | Standard Deviation 9.4 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Baseline score (day 0) | 58.3 score on a scale | Standard Deviation 8.5 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 4 (day 7) | -1.9 score on a scale | Standard Deviation 6.2 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 6 (day 14) | -3.4 score on a scale | Standard Deviation 8 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline visit 8 (day 21) | -5.1 score on a scale | Standard Deviation 7.1 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 10 (day 28) | -5.7 score on a scale | Standard Deviation 9.2 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 12 (day 35) | -4.2 score on a scale | Standard Deviation 6.5 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 14 (day 42) | -5.3 score on a scale | Standard Deviation 7.9 |
| Placebo | Change From Baseline in PROMIS® Sleep Disturbance Score at Days 7,14, 21, 28, 35, 42, 49 and End of Treatment (Day 56). | Change from baseline to visit 16 (day 49) | -6.0 score on a scale | Standard Deviation 10.4 |
Secondary
Duration (Days) of Hospitalization During the Treatment Phase
Duration (in days) of hospitalization required during treatment phase
Time frame: Between baseline (start of treatment) and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 700mg Leronlimab | Duration (Days) of Hospitalization During the Treatment Phase | 0 days |
| Placebo | Duration (Days) of Hospitalization During the Treatment Phase | 0 days |
Secondary
Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary.
Number of days when any symptoms scored as moderate or severe at baseline (Day 0) are still scored as moderate or severe through day 56 (end of treatment) or symptoms scored as mild or absent at baseline are scored as mild or worse at day 56 (end of treatment).
Time frame: Duration of symptoms from baseline (day 0, start of treatment) and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of dizziness | 11.8 days | Standard Deviation 17.6 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of fast heartbeat | 14.8 days | Standard Deviation 18.7 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) joint pain/swelling | 15.9 days | Standard Deviation 16.7 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of vomiting | 0.3 days | Standard Deviation 0.7 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of cough | 14.9 days | Standard Deviation 18.8 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of Stuff/Runny Nose | 19.3 days | Standard Deviation 23 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of shortness of breath | 11.5 days | Standard Deviation 17.4 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of tightness of chest | 10.3 days | Standard Deviation 14.8 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of fatigue | 6.5 days | Standard Deviation 14 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of exertional malaise | 12.7 days | Standard Deviation 18.8 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) muscle aches / cramps | 16.5 days | Standard Deviation 19.6 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of Muscle Weakness | 17.1 days | Standard Deviation 19.4 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of chills or shivering | 6.6 days | Standard Deviation 11.1 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of feeling hot or feverish | 10.5 days | Standard Deviation 13.6 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of difficulty in concentration | 15.6 days | Standard Deviation 20.3 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of sleep disturbance | 13.3 days | Standard Deviation 17.2 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of headache | 16.0 days | Standard Deviation 16.6 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of sore throat | 10.6 days | Standard Deviation 15.7 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of anxiety | 16.8 days | Standard Deviation 22.3 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of tingling or numbness | 14.0 days | Standard Deviation 19.3 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of nausea | 6.8 days | Standard Deviation 9.8 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of diarrhea | 8.5 days | Standard Deviation 13.7 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of change to sense of smell | 16.8 days | Standard Deviation 21.2 |
| 700mg Leronlimab | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) in change of sense of taste | 13.5 days | Standard Deviation 18.3 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) muscle aches / cramps | 17.7 days | Standard Deviation 16.6 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of sore throat | 9.4 days | Standard Deviation 13.4 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of tightness of chest | 12.3 days | Standard Deviation 17.1 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) in change of sense of taste | 8.6 days | Standard Deviation 17 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of fast heartbeat | 16.0 days | Standard Deviation 15.6 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of Muscle Weakness | 20.8 days | Standard Deviation 17.9 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of dizziness | 16.9 days | Standard Deviation 18.6 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) joint pain/swelling | 18.3 days | Standard Deviation 18.6 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of difficulty in concentration | 11.8 days | Standard Deviation 17.7 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of nausea | 8.5 days | Standard Deviation 12.5 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of chills or shivering | 3.9 days | Standard Deviation 7.7 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of vomiting | 0.6 days | Standard Deviation 1.6 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of change to sense of smell | 8.5 days | Standard Deviation 15.5 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of cough | 7.8 days | Standard Deviation 12.8 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of feeling hot or feverish | 9.9 days | Standard Deviation 16.2 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of Stuff/Runny Nose | 20.7 days | Standard Deviation 20.9 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of anxiety | 15.1 days | Standard Deviation 17.4 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of shortness of breath | 13.9 days | Standard Deviation 17.4 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of diarrhea | 7.1 days | Standard Deviation 9.5 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of sleep disturbance | 14.4 days | Standard Deviation 17.5 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of fatigue | 10.6 days | Standard Deviation 18.4 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of tingling or numbness | 18.3 days | Standard Deviation 19.4 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of exertional malaise | 10.6 days | Standard Deviation 15.3 |
| Placebo | Duration of COVID-19 Associated Symptoms From Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Duration (days) of headache | 17.8 days | Standard Deviation 18 |
Secondary
Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary.
Symptom-free days are defined as number of days when any symptoms scored as mild, moderate or severe at baseline are scored as absent (or none) through Day 56 (end of treatment) using a self-assessment diary.
Time frame: Between start of treatment (day0) and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of cough | 16.8 Days | Standard Deviation 19.4 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of sore throat | 4.9 Days | Standard Deviation 9.8 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of stuffy or runny nose | 8.7 Days | Standard Deviation 13.2 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of shortness of breath | 8.2 Days | Standard Deviation 12 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of tightness of chest | 10.3 Days | Standard Deviation 16.1 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of fast heartbeat | 12.8 Days | Standard Deviation 16.5 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of fatigue | 3.9 Days | Standard Deviation 7.5 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of exertional malaise | 7.2 Days | Standard Deviation 10.5 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of muscle aches and cramps | 9.1 Days | Standard Deviation 13.7 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of muscle weakness | 9.5 Days | Standard Deviation 14.7 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of joint pain/swelling | 10.5 Days | Standard Deviation 17.8 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of chills or shivering | 12.6 Days | Standard Deviation 19.4 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of being hot or feverish | 14.8 Days | Standard Deviation 20.4 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from difficulty concentrating | 4.6 Days | Standard Deviation 9.1 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from sleep disturbance | 10.3 Days | Standard Deviation 12.1 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from headache | 15.4 Days | Standard Deviation 16.2 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from dizziness | 11.0 Days | Standard Deviation 18.5 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from anxiety | 5.1 Days | Standard Deviation 11 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from tingling or numbness | 16.5 Days | Standard Deviation 20.1 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from nausea | 14.0 Days | Standard Deviation 19.8 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from diarrhea | 8.3 Days | Standard Deviation 15 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from change in sense of smell | 7.8 Days | Standard Deviation 14.2 |
| 700mg Leronlimab | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from change in sense of taste | 8.8 Days | Standard Deviation 16.3 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of chills or shivering | 16.6 Days | Standard Deviation 21.6 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of cough | 11.3 Days | Standard Deviation 17.1 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from anxiety | 12.4 Days | Standard Deviation 16.4 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of sore throat | 11.5 Days | Standard Deviation 18.5 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of being hot or feverish | 14.5 Days | Standard Deviation 18.2 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of stuffy or runny nose | 12.8 Days | Standard Deviation 17.7 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from diarrhea | 13.6 Days | Standard Deviation 18.3 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of shortness of breath | 15.0 Days | Standard Deviation 17 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from difficulty concentrating | 7.4 Days | Standard Deviation 13.3 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of tightness of chest | 13.4 Days | Standard Deviation 19 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from tingling or numbness | 9.0 Days | Standard Deviation 15.8 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of fast heartbeat | 16.4 Days | Standard Deviation 18.8 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from sleep disturbance | 13.6 Days | Standard Deviation 15.7 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of fatigue | 5.4 Days | Standard Deviation 10.9 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from change in sense of taste | 8.0 Days | Standard Deviation 16.9 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of exertional malaise | 11.1 Days | Standard Deviation 15 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from headache | 12.5 Days | Standard Deviation 16.4 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of muscle aches and cramps | 14.2 Days | Standard Deviation 15.5 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from nausea | 13.9 Days | Standard Deviation 18.1 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of muscle weakness | 12.0 Days | Standard Deviation 16.1 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from dizziness | 9.9 Days | Standard Deviation 15.3 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free of joint pain/swelling | 5.1 Days | Standard Deviation 12.7 |
| Placebo | Number of Days Free of Symptoms Associated With COVID-19 That Were Present at the Start of Study Treatment (Day 0) Based on Self-assessment Using Daily Symptom Diary. | Days free from change in sense of smell | 6.9 Days | Standard Deviation 15.3 |
Secondary
Number of Participants Requiring Hospitalization During the Treatment Phase
Number of participants who required hospitalization during the treatment phase.
Time frame: Between baseline (start of treatment) and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 700mg Leronlimab | Number of Participants Requiring Hospitalization During the Treatment Phase | 0 Participants |
| Placebo | Number of Participants Requiring Hospitalization During the Treatment Phase | 0 Participants |
Secondary
Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline.
Progression or worsening of symptoms is defined as number of days when any symptoms scored as 2 at baseline scored as 3 through day 56 or 1 at baseline are scored as 2 or 3 through day 56 or scored 0 at study entry scored as 1, 2 or 3 through day 56. No change in symptoms would give a score of 0, symptom progression would give a positive number, symptom improvement would a negative number. Minimum baseline symptom score for eligibility for the study was 6. Maximum symptom score is 70, therefore if all symptoms progressed to the severest level the change in score would be +64. If all patients had a severe score for all symptoms at baseline and all improved to no symptoms at day 56, the maximum improvement in score would be -70.
Time frame: Between start of treatment (day0) and day 56 (end of treatment)
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Joint Pain/swelling | -0.8 score on a scale | Standard Deviation 0.7 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Chills and shivering | -0.6 score on a scale | Standard Deviation 0.6 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Tingling or numbness | -0.8 score on a scale | Standard Deviation 1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Vomiting | 0.0 score on a scale | Standard Deviation 0.1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sense of taste | -0.3 score on a scale | Standard Deviation 0.5 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Hot or feverish | -0.5 score on a scale | Standard Deviation 0.8 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Difficulty in concentrating | -1.0 score on a scale | Standard Deviation 1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sleep disturbance | -1.2 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Headache | -1.0 score on a scale | Standard Deviation 1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Dizziness | -0.7 score on a scale | Standard Deviation 1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Anxiety | -0.7 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Nausea | -0.6 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Diarrhea | -0.0 score on a scale | Standard Deviation 0.6 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sense of Smell | -0.3 score on a scale | Standard Deviation 0.5 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Cough | -0.6 score on a scale | Standard Deviation 0.8 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sore throat | -0.1 score on a scale | Standard Deviation 0.7 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Stuffy or runny nose | -0.7 score on a scale | Standard Deviation 0.8 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Shortness of breath | -0.8 score on a scale | Standard Deviation 1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Tightness of chest | -0.6 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Fast heartbeat | -0.8 score on a scale | Standard Deviation 0.8 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Fatigue | -1.1 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Exertional Malaise | -1.1 score on a scale | Standard Deviation 1.1 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Muscle aches and cramps | -0.9 score on a scale | Standard Deviation 0.9 |
| 700mg Leronlimab | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Muscle weakness | -0.9 score on a scale | Standard Deviation 1.1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Exertional Malaise | -0.9 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Joint Pain/swelling | -0.3 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Tightness of chest | -0.3 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sense of Smell | -0.2 score on a scale | Standard Deviation 0.4 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sense of taste | -0.2 score on a scale | Standard Deviation 0.4 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Diarrhea | -0.6 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Stuffy or runny nose | -0.1 score on a scale | Standard Deviation 0.8 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Chills and shivering | -0.5 score on a scale | Standard Deviation 0.8 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Muscle weakness | -0.5 score on a scale | Standard Deviation 0.8 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Hot or feverish | -0.6 score on a scale | Standard Deviation 1.1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Cough | -0.4 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Difficulty in concentrating | -1.1 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Fast heartbeat | -0.5 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sleep disturbance | -1.1 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Sore throat | -0.2 score on a scale | Standard Deviation 0.8 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Headache | -0.7 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Muscle aches and cramps | -0.7 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Dizziness | -0.4 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Fatigue | -1.1 score on a scale | Standard Deviation 1 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Anxiety | -0.8 score on a scale | Standard Deviation 0.8 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Tingling or numbness | -0.3 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Shortness of breath | -0.6 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Nausea | -0.5 score on a scale | Standard Deviation 0.9 |
| Placebo | Progression (or Worsening) of COVID-19-associated Symptoms Through Day 56 Compared to Baseline. | Vomiting | 0.0 score on a scale | Standard Deviation 0.1 |
Other Pre-specified
Change From Baseline in CCR5 Receptor Occupancy on Days 28 and 56.
Exploratory Outcome - Change in CCR5 receptor occupancy from baseline and days 28 and 56 (end of treatment)
Time frame: Change between baseline (start of treatment) and days 28 and 56 (end of treatment)
Other Pre-specified
Change From Baseline in CD4+ and CD8+ T Cell Count on Days 28 and 56.
Exploratory Outcome - Change from baseline in CD4+ and CD8+ T cell count
Time frame: Change between baseline (start of treatment) and days 28 and 56 (end of treatment)
Other Pre-specified
Change From Baseline in C-reactive Protein (CRP) on Days 28 and 56
Exploratory Outcome - Change in C-reactive Protein (CRP) from baseline to Days 28 and 56 (end of treatment)
Time frame: Change between baseline (start of treatment) and days 28 and 56 (end of treatment)
Other Pre-specified
Change From Baseline in Pulse Oxygen Saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, and 56
Exploratory Outcome - Change from baseline in pulse oxygen saturation (SpO2) at Day 7, 14, 21, 28, 35, 42, 49, and 56
Time frame: Change between baseline (start of treatment) and Day 7, 14, 21, 28, 35, 42, 49, and 56 (end of treatment).
Other Pre-specified
Change From Baseline in Serum Cytokine and Chemokine Levels on Days 28 and 56.
Exploratory Outcome - Change from baseline in serum cytokine and chemokine levels
Time frame: Change between baseline (start of treatment) and days 28 and 56 (end of treatment)
Other Pre-specified
Change From Baseline in Transforming Growth Factor Beta 1 (TGF beta1) on Days 28 and 56
Exploratory Outcome - change in TGF-b1 from baseline to days 28 and 56 (end of treatment)
Time frame: Change between baseline (start of treatment) and days 28 and 56 (end of treatment)
Other Pre-specified
Changes in Blood Chemistry, Hematology and Coagulation Parameter Results
Safety Measures - Changes in blood chemistry, hematology and coagulation parameter results
Time frame: Between baseline and day 91
Other Pre-specified
Changes in Electrocardiogram (ECG) Results
Safety Measures - changes in electrocardiogram results
Time frame: Change between baseline and day 91
Other Pre-specified
Changes in Physical Examination Results
Safety Measures - Changes in physical examination results
Time frame: Between baseline and day 91
Other Pre-specified
Changes in Vital Signs Including Temperature, Pulse, Respiratory Rate, Systolic and Diastolic Blood Pressure
Safety Measures - Changes in vital signs including temperature, pulse, respiratory rate, systolic and diastolic blood pressure
Time frame: Between baseline and day 91
Other Pre-specified
Exploration of Biomarkers That May Predict and/or Act as Pharmacodynamic Indicators of Pharmacologic Activity of Leronlimab.
Exploratory Outcome - Exploration of biomarkers that may predict and/or act as pharmacodynamic indicators of pharmacologic activity of leronlimab.
Time frame: 91 Days
Other Pre-specified
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Safety Measures - Incidence and severity of treatment-emergent adverse events
Time frame: Between baseline and day 91
Other Pre-specified
Incidence of Serious Adverse Events (SAEs)
Safety Measures - incidence of severe adverse events
Time frame: Between baseline and day 91
Other Pre-specified
Incidence of TEAEs and SAEs Leading to Discontinuation of Study Medication.
Safety Measures - incidence of TEAEs and SAEs leading to discontinuation of study medication
Time frame: Between baseline and day 56
Other Pre-specified
Incidence of Treatment-related Adverse Events (TEAEs)
Safety Measurement - incidence of treatment emergent adverse events
Time frame: Between baseline and day 91