Status:
UNKNOWN
Clazakizumab vs. Placebo - COVID-19 Infection
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 coronavir...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age \>18 at the time of screening.
- Participant or legally authorized representative (LAR) must be able to understand and provide informed consent.
- 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.
- C-reactive protein (CRP) \> 3.5 mg/dL
- Evidence of pulmonary involvement with at least 2 of the following:
- oxygen saturation at rest in ambient air with peripheral capillary oxygen saturation (SpO2) ≤ 94%
- tachypnea with resting respiration rate \> 25 breaths/minute
- Partial pressure of oxygen (PaO2)/initial fraction of inspired oxygen (FiO2) ≤ 300 mmHg
- Chest imaging (radiograph, CT, or ultrasound) with abnormalities consistent COVID-19 pneumonia
Exclusion
- Previous hypersensitivity or allergic reactions to clazakizumab
- Lactating or pregnant females
- Patients with latent tuberculosis (TB) and who are not receiving treatment
- Patients with active TB
- Patients with known active inflammatory bowel disease, untreated diverticulitis, or gastrointestinal perforation
- Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
- 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
- Participation in another clinical trial investigating COVID-19-aimed agents
- Presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements.
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04494724
Start Date
July 13 2020
End Date
July 31 2021
Last Update
July 31 2020
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030