2019-nCoVNCT04264858
Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients
A study testing Immunoglobulin of cured patients and γ-Globulin in people with 2019-nCoV and Immunoglobulin of Cured Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019-nCoV, Immunoglobulin of Cured Patients
- What is being tested?
- Immunoglobulin of cured patients and γ-Globulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2020to 31 May 2020
- Phase
- Interventional
- 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
- Volunteers who have understood and signed the informed consent;
- Age ≥18 years, gender unlimited;
- Patients diagnosed with acute severe 2019-nCoV pneumonia:
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV.
- Lung involvement confirmed with pulmonary CT scan.
- At least one of the following conditions should be met: respiratory distress, RR ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure.
Who cannot join
- Viral pneumonia with other viruses besides 2019-nCoV.
- Patients are not suitable for immunoglobulin therapy.
- Participation in other studies.
- Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.
- Conditions
- 2019-nCoV, Immunoglobulin of Cured Patients
- Being tested
- Immunoglobulin of cured patients, γ-Globulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin of cured patientsDrug
0.2g/kg, ivdrip, once a day, for 3 days
γ-GlobulinDrug
0.2g/kg, ivdrip, once a day, for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Immunoglobulin of cured patients Receives: Drug: Immunoglobulin of cured patients |
| Control group | Placebo comparator | γ-Globulin Receives: Drug: γ-Globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Improvement (TTCI)
TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).
Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge.
Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Measured: up to 28 days
Secondary outcomes (10)
Clinical status assessed by the ordinal scale
on days 7, 14, 21, and 28
Measured: up to 28 days
The differences in oxygen intake methods
- No need for supplemental oxygenation; 2. nasal cathete oxygen inhalation；3. Mask oxygen inhalation；4. Noninvasive ventilator oxygen supply；5. Invasive ventilator oxygen supply.
Measured: up to 28 days
Duration (days) of supplemental oxygenation
Measured: up to 28 days
Duration (days) of mechanical ventilation
Measured: up to 28 days
The mean PaO2/FiO2
Measured: up to 28 days
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]
The detection frequency could be increased according to clinician's decision
Measured: up to 28 days
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]
Measured: up to 28 days
Dynamic changes of 2019-nCoV antibody titer in blood
The antibody titer is detected on days 3 and 28
Measured: up to 28 days
Length of hospital stay (days)
Measured: up to 28 days
All cause mortality
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start17 Mar 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion31 May 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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264858
- Sponsor's protocol ID
- WuhanUH-2019 nCoV-Ig
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2020
- Last updated
- 17 Mar 2020
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured 2019-nCoV Pneumonia Patients
- ClinicalTrials.gov ID
- NCT04264858
- Acronym / sponsor ID
- WuhanUH-2019 nCoV-Ig
- Conditions
- 2019-nCoV, Immunoglobulin of Cured Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 17 Mar 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 11 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.
The new coronavirus pneumonia is an acute infectious pneumonia. The pathogen is a previously unknown new coronavirus, namely 2019 new coronavirus (2019 novel coronavirus, 2019 nCoV). However, there is no specific anti-viral drug. It has been found that the specific antibodies against virus antigen are produced after these patients were cured, which could block the infection of 2019 nCoV on the host cells. At present, immunoadsorption is the most direct, rapid and effective method to separate immunoglobulin from the cured patients. Therefore, the study aims to prepare the immunoglobulin from 2019-ncov pneumonia cured patients, evaluate the efficacy and safety of the immunoglobulin in 2019-ncov pneumonia cured patients on the treatment of acute severe 2019-ncov pneumonia, and provide a new strategy for the treatment of 2019-ncov pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Immunoglobulin of cured patientsImmunoglobulin of cured patients |
| Control group | Placebo comparator | Drug: γ-Globulinγ-Globulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers who have understood and signed the informed consent;
- Age ≥18 years, gender unlimited;
- Patients diagnosed with acute severe 2019-nCoV pneumonia:
Key exclusion criteria (4 listed)
- Viral pneumonia with other viruses besides 2019-nCoV.
- Patients are not suitable for immunoglobulin therapy.
- Participation in other studies.
- Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial.
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 |
|---|---|---|
| Immunoglobulin of cured patients0.2g/kg, ivdrip, once a day, for 3 days | Drug | Treatment group |
| γ-Globulin0.2g/kg, ivdrip, once a day, for 3 days | Drug | Control group |
Primary outcome
Time to Clinical Improvement (TTCI)
Time frame: up to 28 days
TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
10 secondary outcomes
Clinical status assessed by the ordinal scale
Time frame: up to 28 days
The differences in oxygen intake methods
Time frame: up to 28 days
Duration (days) of supplemental oxygenation
Time frame: up to 28 days
Duration (days) of mechanical ventilation
Time frame: up to 28 days
The mean PaO2/FiO2
Time frame: up to 28 days
The lesions of the pulmonary segment numbers involved in pulmonary CT [ every 7 days]
Time frame: up to 28 days
Time to 2019-nCoV RT-PCR negativity in respiratory tract specimens [every 3 days]
Time frame: up to 28 days
Dynamic changes of 2019-nCoV antibody titer in blood
Time frame: up to 28 days
Length of hospital stay (days)
Time frame: up to 28 days
All cause mortality
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoglobulin of cured patients and γ-Globulin in people with 2019-nCoV and Immunoglobulin of Cured Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site 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 6 inclusion and 4 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Improvement (TTCI) (time frame: up to 28 days). 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 17 Mar 2020.