JPRN-jRCT2021210012
Completed
Phase 2
A phase II clinical trial with HLH-94 protocol, etoposide plus corticosteroid combination therapy, for severe illness patients with COVID-19
Tetsuji Aoyagi0 sites2 target enrollmentJune 14, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- severe illness patients with COVID-19
- Sponsor
- Tetsuji Aoyagi
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Although it is difficult to conclude on the efficacy of the study due to the small number of patients enrolled in the study, no efficacy of the modified HLH-94 protocol was found in the patients for either the primary or secondary endpoints. Safety was considered limited in terms of the occurrence of serious adverse reactions to the study drug.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients who have given written consent to participate in the clinical trial from themselves or a substitute.
- •(2\) Inpatients aged 20 years or older at the time of obtaining consent
- •(3\) Patients who have been confirmed COVID\-19 by a test based on nucleic acid amplification test such as PCR or LAMP method, or by antigen testing.
- •(4\) Patients who meet the following a and b for respiratory status
- •a\=Confirmed COVID\-19 related pneumonia by chest radiography or chest CT scan.
- •b\=Rapid progression of respiratory failure (24\-72 hours)
- •(5\) Patients who are requiring mechanical ventilator.
- •(6\) Patients with any of the following laboratory data suggesting cytokine release syndrome.
- •Ferritin \>500 ng/mL and D\-dimer \>1 microg/mL and at least one of the following; Fever \>38 deg C (within 1 day before registration), Neutrophil count/lymphocyte count ratio \>10, LDH \>400 U/L , CRP \>15 mg/d
Exclusion Criteria
- •(1\) Pregnancy or breastfeeding
- •(2\) History of severe hypersensitivity or adverse reactions to etoposide or prednisolone
- •(3\) Absolute neutrophil count \<1,000/microL
- •(4\) Hemoglobin \<8\.0 g/dL
- •(5\) Platelet count \<50,000/microL
- •(6\) Total bilirubin level \>3\.0 mg/dL
- •(7\) Aspartate OR alanine aminotransferase \> 5\.0 x upper limit of normal
- •(8\) Creatinine Clearance \< 15 mL/min (calculated by Cockcroft Fault formula)
- •(9\) Requiring continuous renal replacement therapy (CRRT)
- •(10\) Requiring extracorporeal membrane oxygenation (ECMO)
Outcomes
Primary Outcomes
Not specified
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