HFRS (Hemorrhagic Fever With Renal Syndrome)Phase 4NCT06009042
Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Prospective Study
A Phase 4 study testing IVIG 20g/d and IVIG 10g/d in people with HFRS (Hemorrhagic Fever With Renal Syndrome), run by Tongji Hospital at 9 sites in China.
Trial summary
The goal of this randomized study to test the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFRS (Hemorrhagic Fever With Renal Syndrome)
- What is being tested?
- IVIG 20g/d and IVIG 10g/d
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jul 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
- The patients must meet all of the following criteria:
- Age ≥ 18 years, regardless of gender;
- Within 5 days of onset, hospitalized patients diagnosed with epidemic hemorrhagic fever (hemorrhagic fever with renal syndrome) must have at least one of the following laboratory test results:
- Positive for serum specific IgM(immunoglobulin M) antibodies;
- Or detect hantavirus RNA(ribonucleic acid) from patient specimens;
- Or the serum specific IgG(immunoglobulin G) antibody titer in the recovery phase is more than four times higher than that in the acute phase;
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- Or hantavirus can be isolated from patient specimens.
- Meet any of the following criteria:
- 1. Severe illness: meet any of the following criteria: (i) Platelet count 20-50×10^9/L; (ii) White blood cell count 15-30×10^9/L. 2. Critical illness: meet any of the following criteria: (i) Platelet count<20×10^9/L; (ii) White blood cell count>30×10^9/L.
- Volunteer to join this study and be able to sign or have a written informed consent form signed by a legal representative.
Who cannot join
- Exclude patients who meet any of the following criteria:
- Patients with primary chronic kidney disease;
- Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract, liver, autoimmune disease or nervous system disease;
- Have a history of malignant tumors (including solid malignant tumors and hematological malignancies etc.);
- Recent use of potentially nephrotoxic drugs;
- Pregnant or potentially pregnant patients;
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- Patients with a history of hypersensitivity to IVIG (intravenous immunoglobulin) ;
- Selective IgA(immunoglobulin A) deficiency patients with IgA antibodies;
- Known or suspected immunodeficiency (human immunodeficiency virus infection, primary immunodeficiency), use of immunosuppressive drugs (glucocorticoids);
- Alcoholics, drug abuse, and psychiatric patients
- Other conditions which researchers deem not suitable for inclusion.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
No.1 Peoples Hospital of Guangshui
Guangshui, Hubei
Qian Liu, 13872857607, liuqian060685@163.com
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei
Wei Huang, 18986552797
- Recruiting
People's Hospital of Luotian County
Huanggang, Hubei
Wei Wang, 13409767486, 196436547@qq.com
- Recruiting
People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
Macheng, Hubei
Yi Zhou, 19971181214, 2513478349@qq.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Long Chuan Zhu, 18851729930, 18851729930@163.com
- Recruiting
Qianjiang Central Hospital
Qianjiang, Hubei
Jun Wang, 13451145526, qjn6249223@163.com
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
Qin Ning, Professor, +8613971521450, qning@vip.sina.com
- Recruiting
Xianning Central Hospital
Xianning, Hubei
Jun Zhu, 13117160652, 1356266581@qq.com
- Recruiting
The Third Peoples Hospital of Yichang
Yichang, Hubei
Quan Ming, 13872658268, 737695825@qq.com
About this study
Official title: Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study
The goal of this randomized study to test the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in the future.
This study will include all hospitalized patients with confirmed severe or critically ill HFRS from October 2021 to October 2023 from 9 centers.
Read more
Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given conventional liquid therapy and symptomatic and supportive treatment.
Participants will be collected demographic, epidemiological history, hospitalization information, clinical data, laboratory data, imaging results, treatment regimens, and outcomes data.
Read the detailed description
This is a multicenter, prospective, randomized controlled study which aims at evaluating the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The participants in each group will receive treatments for 6 days. Both groups are given routine liquid therapy and symptomatic supportive treatment. The main endpoints include transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary endpoints include the incidence of complications and length of hospital stay.
- Being tested
- IVIG 20g/d, IVIG 10g/d
- Keywords
- efficacy, IVIG（intravenous immunoglobulin）
- Medical subject headings
- Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG 20g/dDrug
The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
IVIG 10g/dDrug
The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
| Study group | Role | What they receive |
|---|---|---|
| IVIG 20g/d | Experimental | Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment. Receives: Drug: IVIG 20g/d |
| IVIG 10g/d | Active comparator | Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment. Receives: Drug: IVIG 10g/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transformation rate
The transformation rate is defined as the rate of transformation [critical to severe, moderate or mild, severe to moderate or mild], or the rate of transition [severe to critical].
Measured: up to 34th day after treatment
Post-period rate
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Measured: up to 34th day after treatment
Mortality rate
Measured: up to 34th day after treatment
The duration of the disease
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
Measured: up to 34th day after treatment
Secondary outcomes (2)
The incidence of complications
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
Measured: up to 34th day after treatment
length of hospital stay
The length of hospital stay is defined as the number of days from admission to discharge.
Measured: up to 34th day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (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 HFRS (Hemorrhagic Fever With Renal Syndrome)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
- Investigators
- Qin Ning, Professor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009042
- Sponsor's protocol ID
- PROMISE
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06009042
- Acronym / sponsor ID
- PROMISE
- Keywords
- efficacy, IVIG（intravenous immunoglobulin）
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Aug 2023 (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.
The goal of this randomized study to test the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in the future.
This study will include all hospitalized patients with confirmed severe or critically ill HFRS from October 2021 to October 2023 from 9 centers.
Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given conventional liquid therapy and symptomatic and supportive treatment.
Participants will be collected demographic, epidemiological history, hospitalization information, clinical data, laboratory data, imaging results, treatment regimens, and outcomes data.
Detailed description
This is a multicenter, prospective, randomized controlled study which aims at evaluating the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The participants in each group will receive treatments for 6 days. Both groups are given routine liquid therapy and symptomatic supportive treatment. The main endpoints include transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary endpoints include the incidence of complications and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG 20g/d | Experimental | Drug: IVIG 20g/dParticipants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment. |
| IVIG 10g/d | Active comparator | Drug: IVIG 10g/dParticipants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, regardless of gender;
- Within 5 days of onset, hospitalized patients diagnosed with epidemic hemorrhagic fever (hemorrhagic fever with renal syndrome) must have at least one of the following laboratory test results:
- Meet any of the following criteria:
- 1. Severe illness: meet any of the following criteria: (i) Platelet count 20-50×10^9/L; (ii) White blood cell count 15-30×10^9/L. 2. Critical illness: meet any of the following criteria: (i) Platelet count<20×10^9/L; (ii) White blood cell count>30×10^9/L.
- Volunteer to join this study and be able to sign or have a written informed consent form signed by a legal representative.
Key exclusion criteria (11 listed)
- Patients with primary chronic kidney disease;
- Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract, liver, autoimmune disease or nervous system disease;
- Have a history of malignant tumors (including solid malignant tumors and hematological malignancies etc.);
- Recent use of potentially nephrotoxic drugs;
- Pregnant or potentially pregnant patients;
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 |
|---|---|---|
| IVIG 20g/dThe dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment. | Drug | IVIG 20g/d |
| IVIG 10g/dThe dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment. | Drug | IVIG 10g/d |
Primary outcome
Transformation rate
Time frame: up to 34th day after treatment
The transformation rate is defined as the rate of transformation [critical to severe, moderate or mild, severe to moderate or mild], or the rate of transition [severe to critical].
Post-period rate
Time frame: up to 34th day after treatment
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Mortality rate
Time frame: up to 34th day after treatment
The duration of the disease
Time frame: up to 34th day after treatment
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
2 secondary outcomes
The incidence of complications
Time frame: up to 34th day after treatment
length of hospital stay
Time frame: up to 34th day after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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 Ning, Professor principal investigator
Tongji Hospital
9 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 IVIG 20g/d and IVIG 10g/d in people with HFRS (Hemorrhagic Fever With Renal Syndrome), run by Tongji Hospital at 9 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 10 inclusion and 11 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transformation rate (time frame: up to 34th day after treatment). The study lists 4 primary outcomes in all. 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 24 Aug 2023.