Crizanlizumab for Treating COVID-19 Vasculopathy (CRITICAL)
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|ClinicalTrials.gov Identifier: NCT04435184|
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Crizanlizumab Other: 0.9% saline||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, placebo-controlled, randomized interventional trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Crizanlizumab for Treating COVID-19 Vasculopathy|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.
Crizanlizumab 5.0 mg/kg in 100 ml IV once.
Active Comparator: Placebo Saline
0.9% saline 100 ml IV once.
Other: 0.9% saline
0.9% saline 100 ml IV once.
- Soluble P-selectin level [ Time Frame: Day 7 after randomization ]Level of soluble P-selectin in ng/ml.
- Soluble P-selectin level [ Time Frame: Day 14 after randomization ]Level of soluble P-selectin in ng/ml.
- D-dimer level [ Time Frame: Day 7 after randomization ]Level of D-dimer in mg/L.
- D-dimer level [ Time Frame: Day 14 after randomization ]Level of D-dimer in mg/L.
- VWF level [ Time Frame: Day 7 after randomization ]Level of VWF antigen (percentage).
- VWF level [ Time Frame: Day 14 after randomization ]Level of VWF antigen in (percentage).
- CRP level [ Time Frame: Day 7 after randomization ]Level of C-reactive protein (CRP) in mg/dL.
- CRP level [ Time Frame: Day 14 after randomization ]Level of C-reactive protein (CRP) in mg/dL.
- Change in clinical status as assessed by the World Health Organization (WHO) Ordinal Scale for COVID-19 Trials [ Time Frame: Daily up to day 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
- = Ambulatory; asymptomatic; viral RNA detected
- = Ambulatory; symptomatic; independent
- = Ambulatory; symptomatic; assistance needed
- = Hospitalized; no oxygen therapy
- = Hospitalized; oxygen by mask or nasal prongs
- = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow
- = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200
- = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 or vasopressors
- = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO)
- = Dead
- Time to hospital discharge [ Time Frame: Up to 30 days after randomization ]Time (days) to hospital discharge
- Safety of Crizanlizumab as assessed by adverse events [ Time Frame: Up to day 14 after randomization ]Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435184
|Contact: Charles Lowenstein, MD||(410) firstname.lastname@example.org|
|Contact: Thorsten Leucker, MD PhD||(410) email@example.com|
|Principal Investigator:||Charles J Lowenstein, MD||Johns Hopkins University|