NCT04348500
Trial name or title	Clazakizumab (anti‐IL‐ 6 monoclonal) compared to placebo for COVID19 disease
Methods	RCT, placebo‐controlled, double‐blind study Date of study: April 2020 Location: USA Phase 2
Participants	Randomised: 17 participants Inclusion criteria Age > 18 at the time of screening. Participant must be able to understand and provide informed consent. Hospitalised with COVID19+ disease (confirmed by 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: oxygen saturation at rest in ambient air with SpO2 ≤ 94%; tachypnoea with resting respiration rate > 25 breaths/minute; PaO2/FiO2 ≤ 300 mmHg; chest imaging (radiograph, CT scan, or lung ultrasound) with abnormalities consistent COVID‐19 pneumonia CRP > 35 mg/L Exclusion criteria Previous hypersensitivity or allergic reactions to clazakizumab Lactating or pregnant females. Participants with latent TB and who are not receiving treatment. Participants with active TB A significantly abnormal general serum screening lab result defined as a WBC < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 50 X 103/ml, an SGOT or SGPT > 5X upper limit normal Participation in another clinical trial investigating COVID‐19 aimed agents
Interventions	Intervention: clazakizumab (IV, 25 mg in 50 cc NS x 1 dose) Control interventions: placebo
Outcomes	Primary outcome Adverse events (14 days) Secondary outcomes Mortality (28 days, 60 days)
Starting date	Study start date: 24 April 2020
Contact information	Cedars‐Sinai Medical Center, Stanley Jordan, MD
Notes	Ongoing