Trial NCT04348500
Publication Jordan S, Unpublished (2021) (results posted on registry)
Dates: 2020-04-28 to 2020-07-30
Funding: Private (Vitaeris Inc.)
Conflict of interest: *

Methods
RCT
Blinding: quadruple blinding
Location : Single center / USA
Follow-up duration (days): 60
Inclusion criteria
  • Age >18 at the time of screening
  • Subject must be able to understand and provide informed consent
  • Hospitalized with COVID-19 (+) disease (confirmed by polymerase chain reaction (PCR) assay from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid))
  • Not on mechanical ventilation and/or ECMO
  • Evidence of pulmonary involvement with at least 2 of the following: 1. Oxygen saturation (SpO2) at rest in ambient air with SpO2 ≤ 94%, 2 Tachypnea with resting respiration rate > 25 breaths/minute, 3 Partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ≤ 300 mmHg, 4 Chest imaging (radiograph, CT scan, or lung ultrasound) with abnormalities consistent COVID-19 pneumonia, 5 C-reactive protein (CRP) >35 mg/L
Exclusion criteria
  • Previous hypersensitivity or allergic reactions to clazakizumab
  • Lactating or pregnant females
  • Subjects with latent Tuberculosis (TB) and who are not receiving treatment
  • Subjects with active TB
  • A significantly abnormal general serum screening lab result defined as a White Blood Count (WBC) < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 50 X 103/ml, a serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 5x upper limit normal
  • Participation in another clinical trial investigating COVID-19 aimed agents
Interventions
Treatment
Clazakizumab
25 mg in 50 mL of 0.9% saline intravenously single dose. A second dose could be given after 24 hours up to day 14.
Control
Placebo

Participants
Randomized
participants :
Clazakizumab =8
Placebo=9
Characteristics of participants
N= 17
Mean age : NR
10 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease [ Time Frame: 14 days ]
In the report
NR
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 The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. This is an unpublished study whose results have been reported in ClinicalTrials.gov. The trial was registered prospectively and no important changes were made to primary or secondary outcomes after recruitment start. The trial (n = 17) did not achieve its target sample size (n = 60) and is underpowered to assess statistical significance between the treatment and placebo group.