COVID-19 Infection study: Clazakizumab
Official title Clazakizumab vs. Placebo - COVID-19 Infection
ClinicalTrials.gov ID: NCT04494724
What this study is testing
What is Clazakizumab?
Clazakizumab is an investigational intravenous antibody being studied as a potential treatment for COVID-19 infection. It is designed to block interleukin‑6 (IL‑6) signaling, which may reduce inflammation in the lungs.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether clazakizumab is safe and works to reduce inflammation and lung damage in people with COVID‑19.
- Who it's for
- Adults who have been diagnosed with COVID‑19 infection.
- What's involved
- Participants will be given either clazakizumab, an antibody that blocks inflammation, or a placebo, and will be monitored with medical visits and tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- C-reactive protein (CRP) \> 3.5 mg/dL
- oxygen saturation at rest in ambient air with peripheral capillary oxygen saturation (SpO2) ≤ 94%
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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
- 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 \ 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.