Status:
COMPLETED
Crizanlizumab for Treating COVID-19 Vasculopathy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Novartis
Socar Research SA
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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) \< 94% on room air at screening
- Elevated D-Dimer \> 0.49 mg/L
- Negative pregnancy test for females of childbearing potential
Exclusion
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04435184
Start Date
July 9 2020
End Date
January 4 2021
Last Update
November 9 2021
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287