Covid-19 Clinical Trial
— TACOSOfficial title:
A Retrospective Study of Evaluating Safety and Efficacy of Tocilizumab Compared to Continuous Renal Replacement Therapy in Controlling CRS Triggered by COVID-19
Verified date | March 2020 |
Source | Tongji Hospital |
Contact | YIKAI YU, M.D |
Phone | +1 (484) 995-5917 |
yuyikai[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Hubei Xinhua Hospital, Wuhan central hospital, Wuhan No.1 Hospital |
China,
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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