Crizanlizumab for Treating COVID-19 Vasculopathy

NCT04435184 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00249874
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

coronavirus

Outcome Measures

Primary Outcomes (1)

• Soluble P-selectin Level

  Level of soluble P-selectin in ng/mL.

  Day 3 after randomization or day of hospital discharge, whichever is earlier

Secondary Outcomes (14)

• Soluble P-selectin Level

  Day 7 after randomization

• Soluble P-selectin Level

  Day 14 after randomization

• D-dimer Level

  Day 3 after randomization

• D-dimer Level

  Day 7 after randomization

• D-dimer Level

  Day 14 after randomization

Study Arms (2)

Crizanlizumab

EXPERIMENTAL

Crizanlizumab is a monoclonal antibody targeting P-selectin. Crizanlizumab 5.0 mg/kg in 100 ml IV once.

Drug: Crizanlizumab

Placebo Saline

ACTIVE COMPARATOR

0.9% saline 100 ml IV once.

Other: 0.9% saline

Interventions

Crizanlizumab DRUG

Crizanlizumab 5.0 mg/kg in 100 ml IV once.

Crizanlizumab

0.9% saline OTHER

0.9% saline 100 ml IV once.

Placebo Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Novartis: collaborator
• Socar Research SA: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• Ataga KI, Kutlar A, Kanter J, Liles D, Cancado R, Friedrisch J, Guthrie TH, Knight-Madden J, Alvarez OA, Gordeuk VR, Gualandro S, Colella MP, Smith WR, Rollins SA, Stocker JW, Rother RP. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. N Engl J Med. 2017 Feb 2;376(5):429-439. doi: 10.1056/NEJMoa1611770. Epub 2016 Dec 3.

  PMID: 27959701 BACKGROUND

• Leucker TM, Osburn WO, Reventun P, Smith K, Claggett B, Kirwan BA, de Brouwer S, Williams MS, Gerstenblith G, Hager DN, Streiff MB, Solomon SD, Lowenstein CJ. Effect of Crizanlizumab, a P-Selectin Inhibitor, in COVID-19: A Placebo-Controlled, Randomized Trial. JACC Basic Transl Sci. 2021 Dec;6(12):935-945. doi: 10.1016/j.jacbts.2021.09.013. Epub 2021 Dec 8.

  PMID: 34904132 DERIVED

• Metkus TS, Sokoll LJ, Barth AS, Czarny MJ, Hays AG, Lowenstein CJ, Michos ED, Nolley EP, Post WS, Resar JR, Thiemann DR, Trost JC, Hasan RK. Myocardial Injury in Severe COVID-19 Compared With Non-COVID-19 Acute Respiratory Distress Syndrome. Circulation. 2021 Feb 9;143(6):553-565. doi: 10.1161/CIRCULATIONAHA.120.050543. Epub 2020 Nov 13.

  PMID: 33186055 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

crizanlizumab; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Charles Lowenstein
• Organization: Johns Hopkins University - Baltimore, MD

clowens1@jhmi.edu

4105020391

Study Officials

• Charles J Lowenstein, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized interventional trial.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 17, 2020
• Study Start: July 9, 2020
• Primary Completion: November 28, 2020
• Study Completion: January 4, 2021
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)