Recruiting
Phase 2

Clazakizumab

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT04494724

Conditions

COVID-19 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clazakizumab

Placebo

Study Details

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 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.

Conditions

COVID-19 Infection

Study ID

NCT04494724

Start date

Jul 13, 2020

Status verified date

Jul, 2020

Completion date

Jul 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clazakizumab

Clazakizumab - 25mg in 50 milliliters (mL) of 0.9% saline, IV infusion over 30 minutes.

placebo comparator: Placebo

Placebo - 50 mL 0.9% saline, IV infusion over 30 minutes.

Interventions

Clazakizumab

Infusion

Placebo

Infusion

Primary outcome measure

  • Primary Endpoint [ Time Frame: 24 hours ]

Central Contacts and Locations

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Howard J Huang, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jul 31, 2020

Last verified

Jul, 2020

Keywords

  • COVID-19
  • coronavirus infection
  • respiration, artificial
  • extracorporeal membrane oxygenation
  • randomized controlled trial
  • respiratory distress syndrome, adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2020-07-31.