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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04306705
Other study ID # WHTJCOVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date June 20, 2020

Study information

Verified date March 2020
Source Tongji Hospital
Contact YIKAI YU, M.D
Phone +1 (484) 995-5917
Email yuyikai@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.


Description:

Tocilizumab doesn't directly kill the novel coronavirus. It's known as an inhibitor of the receptor of interleukin 6 (IL-6), a pro-inflammatory cytokine. In the disease COVID-19, the body may respond to the pathogen by overproducing immune cells and their signaling molecules in a dangerous phenomenon called cytokine release storm.It has been recently speculated that IL-6 as a main culprit in that immune over activation among COVID-19 patients, hence the Tocilizumab clinical trial was initiated. In 2017, the FDA also approved Tocilizumab to treat cytokine release syndrome (CRS), a form of cytokine storm caused by CAR-T treatment. The investigator's hypothesis was that Tocilizumab would be associated with better clinical outcomes, such as decreased systemic inflammation, improved survival rate, better hemodynamic and improved of respiratory distress.Systemic inflammatory response syndrome was one of the main indications for treatment with CRRT. So it is clinically significant to compare the efficacy and safety of Tocilizumab and CRRT in management of CRS triggered by COVID-19.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 20, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Agrees to the collection of oropharyngeal or anal swabs and venous blood per protocol.

2. Male or non-pregnant female adult =18 years of age at time of enrollment.

3. Has laboratory-confirmed novel coronavirus infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in oropharyngeal or anal specimen within 72 hours prior to hospitalization.

4. Illness of any duration, and at least one of the following:

1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR

2. Clinical assessment (evidence of rales/crackles on physical examination) AND SpO2 =93% on room air, OR

3. Requiring mechanical ventilation and/or supplemental oxygen, OR

4. Sustained fever in the past 24 hours and unresponsive to NSAID or steroid

5. Serum IL-6 =3 times the upper limit of normal

Exclusion Criteria:

1. Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal.

2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30 ml /min/1.73 m^2)

3. Hemoglobin<80 g/L

4. Leukocytes<2.0×10^9

5. Platelets<50×10^9

6. Pregnancy or breast feeding.

7. Anticipated transfer to another hospital which is not a study site within 72 hours.

8. Expected life span does not exceed 7 days.

9. Allergy to any study medication.

Study Design


Intervention

Drug:
Tocilizumab
Administered as an intravenous infusion.
Other:
Standard of care
Standard of care therapy per local written policies or guidelines and includes balancing of electrolytes and acid-base, the provision of enteral or parenteral nutrients support, antibiotics therapy, oxygen therapy and noninvasive ventilation.
Procedure:
Continuous renal replacement therapy
Catheter insertion site is femoral vein.

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (4)

Lead Sponsor Collaborator
Tongji Hospital Hubei Xinhua Hospital, Wuhan central hospital, Wuhan No.1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants With Normalization of Fever and Oxygen Saturation Through Day 14 This is a composite outcome measure. Criteria for fever normalization: Temperature < 36.6 °C armpit, < 37.2 °C oral sustained for at least 72 hours and criteria for oxygen normalization: peripheral capillary oxygen saturation (Sp02) > 94% sustained for at least 72 hours. First dose date up to 14 days
Secondary Duration of hospitalization Measured in days Up to 28 days
Secondary Proportion of Participants With Normalization of Fever Through Day 14 Criteria for: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 72 hours. First dose date up to 14 days
Secondary Change from baseline in white blood cell and differential count Blood routine test Day 1 through Day 28
Secondary Time to first negative in 2019 novel Corona virus RT-PCR test Oropharyngeal or anal swabs Up to 28 days
Secondary All-cause mortality Date and cause of death (if applicable). up to 12 weeks
Secondary Change from baseline in hsCRP Serum hsCRP Day 1 through Day 28
Secondary Change from baseline in cytokines IL-1ß, IL-10, sIL-2R, IL-6, IL-8 and TNF-a Serum inflammatory cytokines Day 1 through Day 28
Secondary Change from baseline in proportion of CD4+CD3/CD8+CD3 T cells Flow cytometry for peripheral whole blood Day 1 through Day 28 (if applicable)
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