Phase 2
Completed N=50
Crizanlizumab for Treating COVID-19 Vasculopathy
Source: ClinicalTrials.gov NCT04435184 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Nov 2021
Primary outcomePrimary: Soluble P-selectin Level — 7; 39 ng/mL
Summary
The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soluble P-selectin Level |
12; 48 | — |
| SECONDARY Soluble P-selectin Level |
12; 48 | — |
| SECONDARY D-dimer Level |
1.5; 0.7 | — |
| SECONDARY VWF Level |
2.7; 4.6 | — |
| SECONDARY CRP Level |
2.5; 1.3 | — |
| SECONDARY Change in Clinical Status as Assessed by the World Health Organization (WHO) Ordinal Scale for Coronavirus Disease 2019 (COVID-19) Trials |
3; 2; 3; 7; 13; 7 | — |
| SECONDARY Time to Hospital Discharge |
8.1; 6.2 | — |
| SECONDARY Safety of Crizanlizumab as Assessed by Adverse Events |
7; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Willing to provide written informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female ≥ 18 years of age
- 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))
- Currently hospitalized
- Symptoms of acute respiratory infection (at least one of the following: cough, fever > 37.5°C, dyspnea, sore throat, anosmia),
- Radiographic evidence of pulmonary infiltrates
- Requiring supplemental oxygen or the peripheral capillary oxygenation saturation (SpO2) 0.49 mg/L
- Negative pregnancy test for females of childbearing potential
Exclusion Criteria
- Use of home oxygen at baseline
- Current use of mechanical ventilation
- Inability to provide consent
- Do not intubate status
- Prisoner or incarcerated
- Pregnancy or Breast Feeding
- Participation in other interventional therapy trials for COVID-19.
- International normalized ratio (INR) > 3 or activated partial thromboplastin time (aPTT) > 60
Data sourced from ClinicalTrials.gov (NCT04435184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.