A Phase 4 interventional study of Methylprednisolone and intravenous immunoglobulin in Severe Fever With Thrombocytopenia Syndrome, sponsored by Qin Ning. Recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Qin Ning · Phase 4, Interventional, and Treatment
This is a prospective, multicenter, non-randomized, controlled intervention clinical study.Patients with severe fever with thrombocytopenia syndrome who have been clinically diagnosed and met the study inclusion criteria will be included in the study for analysis.
All patients with SFTS will be assigned to different groups according to the ratio of 1:3, including the non-intervention group (conventional treatment group) and the related drug intervention group.
Non-intervention group:patients received conventional treatment during hospitalization.
Intervention group:
Part A group: Patients received methylprednisolone 1-2mg/kg/d（or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d) + intravenous immunoglobulin (IVIG) 0.2g-0.4g/kg/d for a total of 3-5 days. If the disease progressed after treatment, the patients was given the dose of rescue therapy (methylprednisolone > 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone > 2mg/kg/d + IVIG 0.4g/kg/d) for another 3-5 days.
Part B group: Patients received tocilizumab 4mg/kg once.
Part C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days. If the platelet count is less than 30 × 10\^9/L, the low molecular weight heparin should be discontinued.
All patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.
Qin Ning is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional exclusion criteria for Part B:
Patients with \< 50×10\^9/L
Additional exclusion criteria for Part C:
Significant bleeding risk as evidenced by one of the following conditions:
Clinical: Surgery that requires general or spinal anesthesia within 24 hours prior to enrollment, or may require such surgery within the next 24 hours; Evidence of active bleeding; A history of severe head trauma requiring hospitalization; History of intracranial surgery or stroke or any cerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass within 3 months prior to the study; History of congenital hemorrhage; Gastrointestinal bleeding occurred within 6 weeks before the study unless corrective surgery was performed; Trauma that is thought to increase the risk of bleeding; The presence of an epidural catheter; Laboratory: > 2.0, or thrombelastogram results suggest significant hyperfibrinolysis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
Other: conventional treatment
Part A group: Patients received methylprednisolone 1-2mg/kg/d（or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d) + IVIG 0.2g-0.4g/kg/d for a total of 3-5 days. If the disease progressed after treatment, the patients were given the dose of rescue therapy (methylprednisolone \> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \> 2mg/kg/d + IVIG 0.4g/kg/d) for another 3-5 days. Part B group: Patients received tocilizumab 4mg/kg once. Part C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days. All patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.
Drug: Methylprednisolone · Drug: intravenous immunoglobulin · Drug: Tocilizumab · Drug: Low molecular weight heparin · Other: conventional treatment
Methylprednisolone:1-2mg/kg/d(or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d),ivgtt,3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (methylprednisolone \> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \> 2mg/kg/d) was continued for another 3-5 days.
intravenous immunoglobulin:0.2g-0.4g/kg/d,ivgtt, 3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (IVIG 0.4g/kg/d) was continued for another 3-5 days.
Tocilizumab:4mg/kg, once
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
28-day survival rate
28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.
Time frame: From enrollment to 28 day
Incidence of complications
The complications include Respiratory system, gastrointestinal system, blood system, nervous system, liver and kidney, lymphatic system, multiple organ dysfunction syndrome may be related to Severe Fever With Thrombocytopenia Syndrome.Incidence of complications was defined as the proportion of complications occur after enrollment.
Time frame: From enrollment to 28 day
Incidence of AEs
Incidence of adverse events associated with trial drug treatment: blood glucose, electrolyte disturbances, osteoporosis, Cushing's syndrome, double infection, active bleeding, etc.
Time frame: From enrollment to 28 day
Biomarkers associated with efficacy
Blood, bone marrow, lymph node, urine and stool samples were collected to explore biomarkers associated with predicting the efficacy of methylprednisolone combined with IVIG, tocilizumab and low molecular weight heparin in the treatment of severe fever with thrombocytopenia syndrome.
Time frame: From enrollment to 12 month
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Studies of the drugs tested here: Methylprednisolone · Immunoglobulins, Intravenous · Tocilizumab · Heparin, Low-Molecular-Weight
Severe Fever with Thrombocytopenia Syndrome
Qin Ning