Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for adults hospitalized with COVID-19 to see if the drug clazakizumab can help reduce lung damage by blocking inflammation. Participants will receive either the drug or a placebo, which is an inactive substance.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I can provide informed consent.
I have been hospitalized with COVID-19 confirmed by a PCR test within the last 72 hours.
My C-reactive protein (CRP) level is over 3.5 mg/dL.
I have at least two signs of lung involvement, like low oxygen levels.
You may not be able to join if
I have had an allergic reaction to clazakizumab.
I am pregnant or breastfeeding.
I have untreated latent tuberculosis (TB).
I have active TB.
I have known active inflammatory bowel disease.
I need mechanical ventilation or ECMO.
I have significantly abnormal lab results.
I am participating in another COVID-19 trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 blo…
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.
Trial Locations
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Eligibility Criteria
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, …
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.
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