Trial NCT04435184
Publication Leucker T, JACC (2021) (published paper)
Dates: 2020-07-15 to 2020-11-27
Funding: Private (Novartis)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Multicenter / USA
Follow-up duration (days): 30
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 (NAT or RT-PCR)
  • Currently hospitalized
  • Symptoms of acute respiratory infection (at least one of the following: cough, fever > 37.5°C, dyspnea, sore throat, anosmia) within past 10 days
  • 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 criteria
  • Use of home oxygen at baseline
  • Current use of mechanical ventilation
  • Inability to provide informed consent
  • Do Not Intubate status
  • Prisoner or incarcerated status
  • Pregnant or nursing (lactating) women
  • Participation in other interventional drug trials for COVID19 (emergency use or unblinded use of convalescent plasma is permitted)
  • INR > 3 or aPTT > 60
Interventions
Treatment
Crizanlizumab
5.0 mg/kg IV once-off
Control
Placebo

Participants
Randomized
participants :
Placebo=27
Crizanlizumab=27
Characteristics of participants
N= 54
Mean age : NR
24 males
Severity : Mild: n=8 / Moderate: n=32 / Severe: n=2 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Soluble P-selectin Level [ Time Frame: Day 3 after randomization or day of hospital discharge, whichever is earlier ]
In the report
The difference between treatment groups in levels of soluble P-selectin at day 3 after randomization or hospital discharge day, whichever occurred earlier
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the study registry and protocol with statistical analysis plan were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The primary and main secondary outcomes in the article reflect those in the registry. The article also reports post hoc exploratory outcomes. The trial (n = 54) achieved its target sample size (n = 40).