Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)

NCT05604859 | Unknown Phase 4 DMC

• 1 other identifier: UNBRELLA STUDY
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Severe Fever With Thrombocytopenia Syndrome

Keywords

interleukin-6; D-D dimer; efficacy; safety; severe SFTS

Outcome Measures

Primary Outcomes (1)

• 28-day survival rate

  28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.

  From enrollment to 28 day

Secondary Outcomes (2)

• Incidence of complications

  From enrollment to 28 day

• Incidence of AEs

  From enrollment to 28 day

Other Outcomes (1)

• Biomarkers associated with efficacy

  From enrollment to 12 month

Study Arms (2)

non-intervening group

ACTIVE COMPARATOR

conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.

Other: conventional treatment

intervention group

EXPERIMENTAL

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

Interventions

Methylprednisolone DRUG

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.

intervention group

intravenous immunoglobulin DRUG

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.

intervention group

Tocilizumab DRUG

Tocilizumab:4mg/kg, once

intervention group

Low molecular weight heparin DRUG

Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days

intervention group

conventional treatment OTHER

conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.

intervention group; non-intervening group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years. 2. SFTS Patients met the following diagnostic criteria:SFTS-virus (SFTSV) positive in peripheral blood detected by RT-PCR or Next Generation Sequencing (NGS) .
• \. The intervention group shall meet the following conditions:
• Part A: Treatment can be initiated if the patient has two of the following conditions: (1) Persistent high fever for 7 days or more; (2) Platelets less than 50×10\^9/L; (3) Multiple organ function impairment (MODS) including brain, heart, liver, kidney and blood coagulation; (4) Failure of more than 1 organ, such as brain, heart, liver, kidney and coagulation.
• Part B: Serum cytokine IL-6 quantification \>2 times the upper limit of normal (ULN).
• Part C: Plasma D-D dimer ≥ 4×ULN. 4. Sign written informed consent and cooperate with follow-up.

You may not qualify if:

• Patients with neoplastic diseases.
• Patients with severe chronic diseases, such as chronic kidney disease stage 3-5, chronic heart failure, decompensated cirrhosis, chronic diseases of the central nervous system, hematologic neoplastic diseases, uncontrolled solid tumors, etc.
• Patients who are or may be pregnant.
• Patients with a history of hypersensitivity reaction to the trial drug and its components.
• Patients with conditions that the investigator judged to affect short-term survival.
• Patients with platelet \< 50×10\^9/L
• Received vasopressor therapy for more than 36 hours before enrollment;
• Indications for anticoagulant therapy (such as ACS, acute VTE, mechanical valve, etc.);
• 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: INR \> 2.0, or thrombelastogram results suggest significant hyperfibrinolysis.
• Present with other forms of shock that are clinically apparent, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock.

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (10)

Guangshui First Peoples Hospital

Guangshui, Hubei, China

RECRUITING

Huanggang Central Hospital

Huanggang, Hubei, China

NOT YET RECRUITING

Luotian County Peoples Hospital

Huanggang, Hubei, China

RECRUITING

Macheng Peoples Hospital

Macheng, Hubei, China

RECRUITING

Qianjiang Central Hospital

Qianjiang, Hubei, China

NOT YET RECRUITING

Suizhou Central Hospital

Suizhou, Hubei, China

RECRUITING

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xianning Central Hospital

Xianning, Hubei, China

NOT YET RECRUITING

Yichang Third Peoples Hospital

Yichang, Hubei, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

MeSH Terms

Conditions

Severe Fever with Thrombocytopenia Syndrome

Interventions

Methylprednisolone; Immunoglobulins, Intravenous; tocilizumab; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Tick-Borne Diseases; Vector Borne Diseases; Infections; Bunyaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Qin Qin, MD., PhD

  Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

  STUDY CHAIR

Central Study Contacts

Qin Ning, MD., PhD

CONTACT

+8602783662391; qning@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Chair of Department of Infectious Diseases

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 3, 2022
• Study Start: August 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

CN (10)