Clazakizumab vs placebo for COVID-19 with lung involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial conducted at Houston Methodist Hospital to evaluate the safety and potential benefit of clazakizumab in adults with COVID-19 and pulmonary involvement. Eligible participants are hospitalized adults with confirmed COVID-19, CRP above 3.5 mg/dL, and objective signs of lung involvement. After initial randomization, participants may switch to an open-label clazakizumab dose if there is no improvement or deterioration within 24 hours to 14 days. The primary focus is safety and tolerability, with exploration of reduction in progression to acute respiratory distress syndrome (ARDS).

Why it matters

Who can join: the full rules

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.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Howard Huang, MD — The Methodist Hospital Research Institute
• Study coordinator: Isioma Agboli, MD
• Email: iagboli@houstonmethodist.org
• Phone: 713-441-6311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.