2019-nCoVPhase 2/3NCT04261426
The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia
A Phase 2/3 study testing Intravenous Immunoglobulin in people with 2019-nCoV, run by Peking Union Medical College Hospital.
Trial summary
In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019-nCoV
- What is being tested?
- Intravenous Immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2020to 30 Jun 2020
- Phase
- Phase 2/3
- 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
- Adult aged >=18years old;
- Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
- The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
- Meet any of the following criteria for severe or critical ill conditions:
- Respiratory rate >=30/min; or
- Rest SPO2<=90%; or
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- PaO2/FiO2<=300mmHg; or
- Respiratory failure and needs mechanical ventilation; or
- Shock occurs; or
- Multiple organ failure and needs ICU monitoring;
- Sign the Informed Consent Form on a voluntary basis.
Who cannot join
- Exist of other evidences that can explain pneumonia including but not limited to:
- influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;
- Allergy to Intravenous Immunoglobulin or its preparation components;
- Patients with selective IgA deficiency
- Women who are pregnant or breast-feeding;
- Researchers consider unsuitable.
Trial locations and contacts
No sites are listed yet.
Wei Cao contact
About this study
Official title: A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
Read the detailed description
In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care.
Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV.
This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.
- Conditions
- 2019-nCoV
- Being tested
- Intravenous Immunoglobulin, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ImmunoglobulinDrug
Also called Human Immunoglobulin (pH4) for Intravenous Injection
IVIG 0.5g/kg/d for 5 days
Standard careOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| IVIG therapy+ standard care | Experimental | Not described Receives: Drug: Intravenous Immunoglobulin; Other: Standard care |
| Standard care | Placebo comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement based on the 7-point scale
A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measured: 28 days after randomization
Lower Murray lung injury score
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measured: 7 days after randomization
Lower Murray lung injury score
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Measured: 14 days after randomization
Secondary outcomes (8)
28-day mortality
Number of deaths during study follow-up
Measured: Measured from Day 0 through Day 28
Duration of mechanical ventilation
Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
Measured: Measured from Day 0 through Day 28
Duration of hospitalization
Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
Measured: Measured from Day 0 through Day 28
Proportion of patients with negative RT-PCR results
Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.
Measured: 7 and 14 days after randomization
Proportion of patients in each category of the 7-point scale
Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Measured: 7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors
Proportion of patients with different inflammation factors in normalization range.
Measured: 7 and 14 days after randomization
Frequency of Adverse Drug Events
Frequency of Adverse Drug Events
Measured: Measured from Day 0 through Day 28
Frequency of Serious Adverse Drug Events
Frequency of Serious Adverse Drug Events
Measured: Measured from Day 0 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start10 Feb 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoVStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital
- Responsible party
- Principal investigator, LI Taisheng, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261426
- Sponsor's protocol ID
- IVIG-001
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Single-center Study to Evaluate the Efficacy of Intravenous Immunoglobulin Therapy in Patients With Severe 2019- nCoV Pneumonia
- ClinicalTrials.gov ID
- NCT04261426
- Acronym / sponsor ID
- IVIG-001
- Conditions
- 2019-nCoV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital
- Study start
- 10 Feb 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 7 Feb 2020 (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.
In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.
Detailed description
In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care.
Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV.
This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG therapy+ standard care | Experimental | Drug: Intravenous Immunoglobulin, Other: Standard care |
| Standard care | Placebo comparator | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult aged >=18years old;
- Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
- The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
- Meet any of the following criteria for severe or critical ill conditions:
- Sign the Informed Consent Form on a voluntary basis.
Key exclusion criteria (6 listed)
- Exist of other evidences that can explain pneumonia including but not limited to:
- influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;
- Allergy to Intravenous Immunoglobulin or its preparation components;
- Patients with selective IgA deficiency
- Women who are pregnant or breast-feeding;
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 |
|---|---|---|
| Intravenous ImmunoglobulinAlso: Human Immunoglobulin (pH4) for Intravenous InjectionIVIG 0.5g/kg/d for 5 days | Drug | IVIG therapy+ standard care |
| Standard careStandard care | Other | IVIG therapy+ standard care, Standard care |
Primary outcome
Clinical improvement based on the 7-point scale
Time frame: 28 days after randomization
A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).
Lower Murray lung injury score
Time frame: 7 days after randomization
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
Lower Murray lung injury score
Time frame: 14 days after randomization
Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.
8 secondary outcomes
28-day mortality
Time frame: Measured from Day 0 through Day 28
Duration of mechanical ventilation
Time frame: Measured from Day 0 through Day 28
Duration of hospitalization
Time frame: Measured from Day 0 through Day 28
Proportion of patients with negative RT-PCR results
Time frame: 7 and 14 days after randomization
Proportion of patients in each category of the 7-point scale
Time frame: 7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors
Time frame: 7 and 14 days after randomization
Frequency of Adverse Drug Events
Time frame: Measured from Day 0 through Day 28
Frequency of Serious Adverse Drug Events
Time frame: Measured from Day 0 through Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Wei Cao contact
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous Immunoglobulin in people with 2019-nCoV, run by Peking Union Medical College Hospital.
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 11 inclusion and 6 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Taisheng Li (010-69155086, litsh@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement based on the 7-point scale (time frame: 28 days after randomization). The study lists 3 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 7 Feb 2020.