Crizanlizumab for Treating COVID-19 Vasculopathy

• Status: Completed
• Trial end date: 2021-01-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Brigham and Women's Hospital; Novartis; Socar Research SA

Criteria

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