The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the
safety and efficacy of clazakizumab vs placebo for the prevention of acute respiratory
distress syndrome (ARDS) in patients with COVID-19 and pulmonary manifestations. The study
will compare clazakizumab to placebo in a randomized, double-blind fashion followed by an
open-label dose of clazakizumab if there is no improvement or a worsening of condition occurs
after 24-hours or anytime during the first 14 days after the first dose of clazakizumab or
placebo. We hypothesize that clazakizumab will be safely tolerated and will reduce the risk
of progression of COVID-19 to acute respiratory distress syndrome.
Primary Objective:
• To evaluate the safety and tolerability of clazakizumab vs placebo for the treatment of
patients with COVID-19 disease and signs of pulmonary involvement
Sixty adult patients with COVID-19 and signs of pulmonary involvement at Houston Methodist
who are not in need of ventilator support at the time of enrollment.
Drug: Clazakizumab
Infusion
Drug: Placebo
Infusion
Inclusion Criteria:
1. Age >18 at the time of screening.
2. Participant or legally authorized representative (LAR) must be able to understand and
provide informed consent.
3. Hospitalized with coronavirus disease (COVID-19) confirmed by polymerase chain
reaction (PCR) assay from any specimen (eg, respiratory, blood, urine, stool, other
bodily fluid) within the prior 72 hours.
4. C-reactive protein (CRP) > 3.5 mg/dL
5. Evidence of pulmonary involvement with at least 2 of the following:
1. oxygen saturation at rest in ambient air with peripheral capillary oxygen
saturation (SpO2) ≤ 94%
2. tachypnea with resting respiration rate > 25 breaths/minute
3. Partial pressure of oxygen (PaO2)/initial fraction of inspired oxygen (FiO2) ≤
300 mmHg
4. Chest imaging (radiograph, CT, or ultrasound) with abnormalities consistent
COVID-19 pneumonia
Exclusion Criteria:
1. Previous hypersensitivity or allergic reactions to clazakizumab
2. Lactating or pregnant females
3. Patients with latent tuberculosis (TB) and who are not receiving treatment
4. Patients with active TB
5. Patients with known active inflammatory bowel disease, untreated diverticulitis, or
gastrointestinal perforation
6. Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
7. A significantly abnormal general serum screening lab result defined as a white blood
cell (WBC) count < 3.0 X 10^3/mL, a hemoglobin (Hgb) < 8.0 g/dL, a platelet count < 50
X 10^3/mL, an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5
times upper limit normal
8. Participation in another clinical trial investigating COVID-19-aimed agents
9. Presence of any medical or psychosocial condition, which the investigator believes,
would hinder adherence to the study requirements.
Houston Methodist Hospital
Houston, Texas, United States
Investigator: Isioma Agboli, MD
Contact: 713-441-6311
iagboli@houstonmethodist.org
Investigator:
Isioma Agboli, MD
713-441-6311
iagboli@houstonmethodist.org
Darrel Cleere, BSN
713-441-6232
dwcleere@houstonmethodist.org
Howard Huang, MD, Principal Investigator
The Methodist Hospital Research Institute