Clazakizumab (Anti-IL- 6 Monoclonal) Compared to Placebo for COVID19 Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04348500|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID19||Drug: Clazakizumab||Phase 2|
Patients admitted to hospital with COVID-19 disease with signs of pulmonary involvement will be randomized to receive the anti- IL-6 drug clazakizumab 25mg IV or placebo. Patients will be followed for improvements in clinical symptoms and laboratory parameters which are part of our COVID-19 lab panel described below. Patients will receive SOC supportive treatment and will be followed for 14 days. If a patient from either group progresses to the need for mechanical ventilation and/or ECMO, or develops clinical signs of deteriorating COVID-19 disease, and there are no serious treatment related SAEs, at the discretion of the investigator or treating physician, the patient may receive a single dose of open-label clazakizumab 25mg IV. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab.
Enrolled patients will receive clazakizumab 25 mg or placebo (0.9% saline) given by IV infusion over 30 minutes. Clazakizumab will be administered in 50 mL of 0.9% saline on Day 1.
COVID-19 lab panel and clinical parameters will be monitored to determine if patients are progressing towards need for ventilation and/or ECMO. The parameters below will be monitored and patient status will be assessed by the clinical team.
If patients do develop these criteria, open-label clazakizumab 25 mg IV may be administered as discussed above. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. Patients ventilated with or without ECMO will continue to be monitored post-treatment for signs of improvement, (i.e., decreasing FiO2 requirements, CXR improvements, CRP reductions, extubation and discharge home) or death.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo[0.9% saline]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or ECMO. If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events(SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV X 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Blinded IP (clazakizumab or placebo) will be given initially, followed by the option of an open label dose of clazakizumab within the first 14 days of initial IP administration|
|Official Title:||A Phase II Trial to Evaluate the Safety and Tolerability of Clazakizumab® (Anti-IL- 6 Monoclonal) Compared to Placebo for the Treatment of COVID-19 Infection|
|Estimated Study Start Date :||April 21, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Active Comparator: Clazakizumab
25 mg in 50 cc NS given by IV infusion x 1 dose
Placebo Comparator: Placebo
50 cc NS given by IV infusion x 1 dose
- Evaluate the safety and efficacy of clazakizumab for the treatment of patients with COVID-19 disease and signs of pulmonary involvement [ Time Frame: 14 days ]Incidence of need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo
- Patient survival at 28 days [ Time Frame: 28 days ]Number of patients alive at 28 days
- Patient survival at 60 days [ Time Frame: 60 days ]Number of patients alive at 60 days
- Number of patients requiring the dose of open-label clazakizumab [ Time Frame: 14 days ]Number of patients requiring the dose of open-label clazakizumab
- Reduced duration of intensive care unit stay [ Time Frame: 60 days ]Number of days in ICU compared to placebo
- Reduced duration of hospital stay [ Time Frame: 60 days ]Number of days in hospital compared to placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348500
|Contact: Noriko Ammerman, PharmDemail@example.com|