COVID-19
Conditions
Keywords
coronavirus
Brief summary
The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
Detailed description
Infection with severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) causes coronavirus disease 2019 (COVID-19). The clinical course of COVID-19 is variable, and some patients develop severe pneumonia, multi-organ failure, and shock. Severe COVID-19 is characterized by a hyper-inflammatory and hyper-thrombotic state. We propose that this state is caused by viral injury of the vascular endothelium, leading to endothelial release of von Willebrand Factor (VWF) and P-selectin, which in turn drive thrombosis and vascular inflammation. Crizanlizumab is a monoclonal antibody that targets P-selectin. Crizanlizumab can decrease inflammation by binding to P-selectin, blocking leucocyte and platelet adherence to the vessel wall. We now plan to test the safety and efficacy of crizanlizumab in decreasing biomarkers of inflammation and thrombosis in a placebo-controlled, double-blind randomized clinical trial
Interventions
DRUGCrizanlizumab
Crizanlizumab 5.0 mg/kg in 100 ml IV once.
OTHER0.9% saline
0.9% saline 100 ml IV once.
Sponsors
Novartis
Socar Research SA
Brigham and Women's Hospital
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, placebo-controlled, randomized interventional trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing to provide written informed consent 2. Willing to comply with all study procedures and be available for the duration of the study 3. Male or female ≥ 18 years of age 4. SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR)) 5. Currently hospitalized 6. Symptoms of acute respiratory infection (at least one of the following: cough, fever \> 37.5°C, dyspnea, sore throat, anosmia), 7. Radiographic evidence of pulmonary infiltrates 8. Requiring supplemental oxygen or the peripheral capillary oxygenation saturation (SpO2) \< 94% on room air at screening 9. Elevated D-Dimer \> 0.49 mg/L 10. Negative pregnancy test for females of childbearing potential
Exclusion criteria
1. Use of home oxygen at baseline 2. Current use of mechanical ventilation 3. Inability to provide consent 4. Do not intubate status 5. Prisoner or incarcerated 6. Pregnancy or Breast Feeding 7. Participation in other interventional therapy trials for COVID-19. 8. International normalized ratio (INR) \> 3 or activated partial thromboplastin time (aPTT) \> 60
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soluble P-selectin Level | Day 3 after randomization or day of hospital discharge, whichever is earlier | Level of soluble P-selectin in ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| D-dimer Level | Day 3 after randomization | Level of D-dimer in mg/L. |
| VWF Level | Day 3 after randomization | Level of von Willebrand Factor (VWF) antigen in IU/mL. |
| CRP Level | Day 3 after randomization | Level of C-reactive protein (CRP) in mg/dL. |
| Soluble P-selectin Level | Day 7 after randomization | Level of soluble P-selectin in ng/mL. |
| Time to Hospital Discharge | Up to 30 days after randomization | Time (days) to hospital discharge |
| Safety of Crizanlizumab as Assessed by Adverse Events | Up to day 14 after randomization | Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions. |
| Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | Days 3, 7 and 14 after randomization | Change in the clinical status over 14 days as measured by an ordinal scale that is the first assessment of the clinical status on a given study day. The scale is as follows: 0 = Uninfected; no viral RNA detected 1. = Ambulatory; asymptomatic; viral RNA detected 2. = Ambulatory; symptomatic; independent 3. = Ambulatory; symptomatic; assistance needed 4. = Hospitalized; no oxygen therapy 5. = Hospitalized; oxygen by mask or nasal prongs 6. = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow 7. = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200 8. = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 \< 150 or SpO2/FIO2 \< 200 or vasopressors 9. = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 \< 150 or SpO2/FIO2 \< 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) 10. = Dead |
Countries
United States
Participant flow
Recruitment details
From July 15, 2020 through November 27, 2020, 583 patients were screened at 3 hospitals within the Johns Hopkins Health System. A total of 54 patients who fulfilled study entry criteria were randomized to receive crizanlizumab (n = 27) or placebo (n = 27).
Pre-assignment details
Out of the 27 assigned to receive crizanlizumab, 2 did not receive crizanlizumab because of early discharge or early intubation. Out of the 27 assigned to receive placebo, 2 did not receive placebo because of early discharge or withdrawn consent.
Participants by arm
| Arm | Count |
|---|---|
| Crizanlizumab Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.
Crizanlizumab: Crizanlizumab 5.0 mg/kg in 100 ml IV once. | 22 |
| Placebo Saline 0.9% saline 100 ml IV once.
0.9% saline: 0.9% saline 100 ml IV once. | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | follow-up blood draws missing | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo Saline | Total | Crizanlizumab |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 11 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 31 Participants | 19 Participants |
| Age, Continuous | 54.6 years STANDARD_DEVIATION 13.4 | 56.2 years STANDARD_DEVIATION 15.5 | 58 years STANDARD_DEVIATION 17.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 20 Participants | 14 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 | 13 Participants | 21 Participants | 8 Participants |
| Region of Enrollment United States | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 24 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 7 / 25 | 5 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
Primary
Soluble P-selectin Level
Level of soluble P-selectin in ng/mL.
Time frame: Day 3 after randomization or day of hospital discharge, whichever is earlier
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizanlizumab | Soluble P-selectin Level | 7 ng/mL | Standard Deviation 7 |
| Placebo Saline | Soluble P-selectin Level | 39 ng/mL | Standard Deviation 18 |
Secondary
Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials
Change in the clinical status over 14 days as measured by an ordinal scale that is the first assessment of the clinical status on a given study day. The scale is as follows: 0 = Uninfected; no viral RNA detected 1. = Ambulatory; asymptomatic; viral RNA detected 2. = Ambulatory; symptomatic; independent 3. = Ambulatory; symptomatic; assistance needed 4. = Hospitalized; no oxygen therapy 5. = Hospitalized; oxygen by mask or nasal prongs 6. = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow 7. = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200 8. = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 \< 150 or SpO2/FIO2 \< 200 or vasopressors 9. = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 \< 150 or SpO2/FIO2 \< 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) 10. = Dead
Time frame: Days 3, 7 and 14 after randomization
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 7 | 1 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 4 | 3 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 8 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 9 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 9 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 6 | 3 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 10 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 10 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | </= 3 (discharged) | 21 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | </= 3 (discharged) | 9 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 4 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | </= 3 (discharged) | 3 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 5 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 4 | 5 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 6 | 1 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 7 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 7 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 5 | 6 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 8 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 5 | 13 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 9 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 6 | 1 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 10 | 0 Participants |
| Crizanlizumab | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 8 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 10 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | </= 3 (discharged) | 2 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 4 | 7 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 5 | 7 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 6 | 4 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 7 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 8 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 9 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | </= 3 (discharged) | 13 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 4 | 3 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 5 | 3 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 6 | 1 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 7 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 8 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 9 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 7 | 10 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | </= 3 (discharged) | 19 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 4 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 5 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 6 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 7 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 8 | 1 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 14 | 9 | 0 Participants |
| Placebo Saline | Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials | WHO Clinical Status: Day 3 | 10 | 0 Participants |
Secondary
CRP Level
Level of C-reactive protein (CRP) in mg/dL.
Time frame: Day 3 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | CRP Level | 4.4 mg/dL |
| Placebo Saline | CRP Level | 4.5 mg/dL |
Secondary
CRP Level
Level of C-reactive protein (CRP) in mg/dL.
Time frame: Day 7 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | CRP Level | 2.4 mg/dL |
| Placebo Saline | CRP Level | 2.1 mg/dL |
Secondary
CRP Level
Level of C-reactive protein (CRP) in mg/dL.
Time frame: Day 14 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | CRP Level | 2.5 mg/dL |
| Placebo Saline | CRP Level | 1.3 mg/dL |
Secondary
D-dimer Level
Level of D-dimer in mg/L.
Time frame: Day 7 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | D-dimer Level | 1.6 mg/L |
| Placebo Saline | D-dimer Level | 0.7 mg/L |
Secondary
D-dimer Level
Level of D-dimer in mg/L.
Time frame: Day 14 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | D-dimer Level | 1.5 mg/L |
| Placebo Saline | D-dimer Level | 0.7 mg/L |
Secondary
D-dimer Level
Level of D-dimer in mg/L.
Time frame: Day 3 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | D-dimer Level | 1.6 mg/L |
| Placebo Saline | D-dimer Level | 0.7 mg/L |
Secondary
Safety of Crizanlizumab as Assessed by Adverse Events
Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions.
Time frame: Up to day 14 after randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crizanlizumab | Safety of Crizanlizumab as Assessed by Adverse Events | 7 total adverse events |
| Placebo Saline | Safety of Crizanlizumab as Assessed by Adverse Events | 6 total adverse events |
Secondary
Soluble P-selectin Level
Level of soluble P-selectin in ng/mL.
Time frame: Day 14 after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizanlizumab | Soluble P-selectin Level | 12 ng/mL | Standard Deviation 10 |
| Placebo Saline | Soluble P-selectin Level | 48 ng/mL | Standard Deviation 24 |
Secondary
Soluble P-selectin Level
Level of soluble P-selectin in ng/mL.
Time frame: Day 7 after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizanlizumab | Soluble P-selectin Level | 10 ng/mL | Standard Deviation 8 |
| Placebo Saline | Soluble P-selectin Level | 48 ng/mL | Standard Deviation 17 |
Secondary
Time to Hospital Discharge
Time (days) to hospital discharge
Time frame: Up to 30 days after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crizanlizumab | Time to Hospital Discharge | 8.1 days | Standard Deviation 4.4 |
| Placebo Saline | Time to Hospital Discharge | 6.2 days | Standard Deviation 3.2 |
Secondary
VWF Level
Level of von Willebrand Factor (VWF) antigen in IU/mL.
Time frame: Day 3 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | VWF Level | 2.9 IU/mL |
| Placebo Saline | VWF Level | 2.8 IU/mL |
Secondary
VWF Level
Level of VWF antigen in IU/mL.
Time frame: Day 14 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | VWF Level | 2.7 IU/mL |
| Placebo Saline | VWF Level | 4.6 IU/mL |
Secondary
VWF Level
Level of VWF antigen in IU/mL.
Time frame: Day 7 after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Crizanlizumab | VWF Level | 3.9 IU/mL |
| Placebo Saline | VWF Level | 3.6 IU/mL |