Severe Fever With Thrombocytopenia SyndromePhase 4NCT05604859
Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)
A Phase 4 study testing Methylprednisolone, intravenous immunoglobulin and Tocilizumab in people with Severe Fever With Thrombocytopenia Syndrome, run by Qin Ning at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Fever With Thrombocytopenia Syndrome
- What is being tested?
- Methylprednisolone, intravenous immunoglobulin and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 10 sitesChina
- Study dates
- 19 Aug 2022to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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) .
- 3. 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.
Who cannot join
- 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.
- Additional exclusion criteria for Part B:
Show all 13Show fewer
- Patients with platelet < 50×10^9/L
- Additional exclusion criteria for Part C:
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Guangshui First Peoples Hospital
Guangshui, Hubei
qian Liu
- Not yet recruiting
Huanggang Central Hospital
Huanggang, Hubei
guoxiang Zhu
- Recruiting
Luotian County Peoples Hospital
Huanggang, Hubei
wei Wang
- Recruiting
Macheng Peoples Hospital
Macheng, Hubei
yi Zhou
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
chuanlong Zhu
- Not yet recruiting
Qianjiang Central Hospital
Qianjiang, Hubei
jun Wang
- Recruiting
Suizhou Central Hospital
Suizhou, Hubei
tiantong Zhou
- Recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Qin Ning, PHD,MD, +8602783662391, qning@vip.sina.com
Qin Ning, PHD,MD
- Not yet recruiting
Xianning Central Hospital
Xianning, Hubei
jun Zhu
- Not yet recruiting
Yichang Third Peoples Hospital
Yichang, Hubei
quan Ming
About this study
Official title: Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study
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.
Read more
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.
- Being tested
- Methylprednisolone, intravenous immunoglobulin, Tocilizumab, Low molecular weight heparin, conventional treatment
- Keywords
- interleukin-6, D-D dimer, efficacy, safety, severe SFTS
- Medical subject headings
- Severe Fever with Thrombocytopenia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 immunoglobulinDrug
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.
TocilizumabDrug
Tocilizumab:4mg/kg, once
Low molecular weight heparinDrug
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
conventional treatmentOther
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
| Study group | Role | What they receive |
|---|---|---|
| non-intervening group | Active comparator | conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc. Receives: 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. Receives: Drug: Methylprednisolone; Drug: intravenous immunoglobulin; Drug: Tocilizumab; Drug: Low molecular weight heparin; Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day survival rate
28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.
Measured: From enrollment to 28 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start19 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Fever With Thrombocytopenia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Qin, MD., PhD, Study chair, Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604859
- Sponsor's protocol ID
- UNBRELLA STUDY
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT05604859
- Acronym / sponsor ID
- UNBRELLA STUDY
- Keywords
- interleukin-6, D-D dimer, efficacy, safety, severe SFTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-intervening group | Active comparator | Other: conventional treatmentconventional treatment，including symptomatic and supportive treatment, antiviral treatment etc. |
| intervention group | Experimental | Drug: Methylprednisolone, Drug: intravenous immunoglobulin, Drug: Tocilizumab, Drug: Low molecular weight heparin, Other: conventional treatmentPart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. 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) .
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneMethylprednisolone: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. | Drug | intervention group |
| intravenous immunoglobulinintravenous 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. | Drug | intervention group |
| TocilizumabTocilizumab:4mg/kg, once | Drug | intervention group |
| Low molecular weight heparinLow molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days | Drug | intervention group |
| conventional treatmentconventional treatment，including symptomatic and supportive treatment, antiviral treatment etc. | Other | intervention group, non-intervening group |
Primary outcome
28-day survival rate
Time frame: From enrollment to 28 day
28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.
2 secondary outcomes
Incidence of complications
Time frame: From enrollment to 28 day
Incidence of AEs
Time frame: From enrollment to 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin Qin, MD., PhD study chair
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone, intravenous immunoglobulin and Tocilizumab in people with Severe Fever With Thrombocytopenia Syndrome, run by Qin Ning at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Ning, MD., PhD (+8602783662391, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day survival rate (time frame: From enrollment to 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.