COVID-19NCT04293692
Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus
A study testing UC-MSCs in people with COVID-19, run by Puren Hospital Affiliated to Wuhan University of Science and Technology at 1 site in China.
Trial summary
The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2020to 25 Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years old ≤ age ≤ 75years old;
- CT image is characteristic of 2019 novel coronavirus pneumonia;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR);
- In compliance with the 2019-nCoV pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards): (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
Who cannot join
- Patients with severe allergies or allergies to stem cells;
- Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc.;
- Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
- In vitro life support (ECMO, ECCO2R, RRT);
- Expected deaths within 48 hours, uncontrolled infections;
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- Patients with malignant blood-borne diseases such as HIV or syphilis;
- Patient with pregnancy, are planning to become pregnant or breastfeeding;
- Patients with poor compliance and unable to complete the full study;
- The investigator determines that there may be increased risk of the subject or other conditions that interfere with the clinical trial and the judgment of the results (such as excessive stress, sensitivity or cognitive impairment, etc.);
- There are other situations that the researchers think are not suitable to participate in this clinical study
Trial locations and contacts
1 site in 1 country.
China1 site
Puren Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, 430081
About this study
Official title: Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus
The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.
Read the detailed description
Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cases have found in other areas of China and abroad. Up to February 24, a total of 77, 779 confirmed cases were reported in China. At present, there is no effective treatment for patients identified with novel coronavirus pneumonia. Therefore, it's urgent to explore more active therapeutic methods to cure the patients.
Recently, some clinical researches about the 2019 novel coronavirus pneumonia published in The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell infiltration and inflammatory cytokines secretion were found in patients' lungs, alveolar epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting to reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.
Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application. They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, and significantly protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.
The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48 patients aged from 18 to 75 years old and had no severe underlying diseases. In the cell treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously treatment 4 times every other day besides conventional treatment. In the control group, other 24 patients received conventional treatment plus 4 times of placebo intravenously. The lung CT, blood biochemical examination, lymphocyte subsets, inflammatory factors, 28-days mortality, etc will be evaluated within 24h and 1, 2, 4, 8 weeks after UC-MSCs treatment.
- Conditions
- COVID-19
- Being tested
- UC-MSCs, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
0.5*10E6 UC-MSCs /kg body weight suspended in 100mL saline containing 1% human albumin intravenously at Day1, Day3, Day5, Day7
PlaceboOther
100mL saline containing 1% human albumin intravenously at Day 1, Day 3, Day 5, Day 7
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs treatment group | Experimental | Participants will receive conventional treatment plus 4 times of 0.5*10E6 UC-MSCs /kg body weight intravenously at Day1, Day3, Day5, Day7). Receives: Biological: UC-MSCs |
| Control group | Placebo comparator | Participants will receive conventional treatment plus 4 times of Placebo intravenously at Day1, Day3, Day5, Day7. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of lesion area by chest imaging
Evaluation of Pneumonia change
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Blood oxygen saturation
Evaluation of Pneumonia change
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Secondary outcomes (8)
Rate of mortality within 28-days
Marker for efficacy of treatment
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Sequential organ failure assessment
0-4 score, the higher the score is, the poor of the prognosis will be.
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Side effects in the UC-MSCs treatment group
Number of participants with treatment-related adverse events
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Electrocardiogram, the changes of ST-T interval mostly
Markers of the heart function
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of C-reactive protein C-reactive protein, immunoglobulin
Markers of infection
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
CD4+ and CD8+ T cells count
Marker of Immunology and inflammation
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α)
Marker of Immunology and inflammation
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of the myocardial enzymes
Markers of the heart function
Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start24 Feb 2020
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: Patients were transferred to designated hospitals for treatment as needed, the clinical trials cannot be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puren Hospital Affiliated to Wuhan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293692
- Sponsor's protocol ID
- Pr20200225
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 18 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus
- ClinicalTrials.gov ID
- NCT04293692
- Acronym / sponsor ID
- Pr20200225
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients were transferred to designated hospitals for treatment as needed, the clinical trials cannot be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Puren Hospital Affiliated to Wuhan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 3 Mar 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 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.
Detailed description
Since late December 2019, human pneumonia cases infected by a novel coronavirus (2019-nCoV) were firstly identified in Wuhan, China. As the virus is contagious and of great epidemic, more and more cases have found in other areas of China and abroad. Up to February 24, a total of 77, 779 confirmed cases were reported in China. At present, there is no effective treatment for patients identified with novel coronavirus pneumonia. Therefore, it's urgent to explore more active therapeutic methods to cure the patients.
Recently, some clinical researches about the 2019 novel coronavirus pneumonia published in The Lancet and The New England Journal of Medicine suggested that massive inflammatory cell infiltration and inflammatory cytokines secretion were found in patients' lungs, alveolar epithelial cells and capillary endothelial cells were damaged, causing acute lung injury. It seems that the key to cure the pneumonia is to inhibit the inflammatory response, resulting to reduce the damage of alveolar epithelial cells and endothelial cells and repair the function of the lung.
Mesenchymal stem cells (MSCs) are widely used in basic research and clinical application. They are proved to migrate to damaged tissues, exert anti-inflammatory and immunoregulatory functions, promote the regeneration of damaged tissues and inhibit tissue fibrosis. Studies have shown that MSCs can significantly reduce acute lung injury in mice caused by H9N2 and H5N1 viruses by reducing the levels of proinflammatory cytokines and the recruitment of inflammatory cells into the lungs. Compared with MSCs from other sources, human umbilical cord-derived MSCs (UC-MSCs) have been widely applied to various diseases due to their convenient collection, no ethical controversy, low immunogenicity, and rapid proliferation rate. In our recent research, we confirmed that UC-MSCs can significantly reduce inflammatory cell infiltration and inflammatory factors expression in lung tissue, and significantly protect lung tissue from endotoxin (LPS) -induced acute lung injury in mice.
The purpose of this clinical study is to investigate safety and efficiency of UC-MSCs in treating pneumonia patients infected by 2019-nCoV. The investigators planned to recruit 48 patients aged from 18 to 75 years old and had no severe underlying diseases. In the cell treatment group, 24 patients received 0.5*10E6 UC-MSCs /kg body weight intravenously treatment 4 times every other day besides conventional treatment. In the control group, other 24 patients received conventional treatment plus 4 times of placebo intravenously. The lung CT, blood biochemical examination, lymphocyte subsets, inflammatory factors, 28-days mortality, etc will be evaluated within 24h and 1, 2, 4, 8 weeks after UC-MSCs treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs treatment group | Experimental | Biological: UC-MSCsParticipants will receive conventional treatment plus 4 times of 0.5*10E6 UC-MSCs /kg body weight intravenously at Day1, Day3, Day5, Day7). |
| Control group | Placebo comparator | Other: PlaceboParticipants will receive conventional treatment plus 4 times of Placebo intravenously at Day1, Day3, Day5, Day7. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18 years old ≤ age ≤ 75years old;
- CT image is characteristic of 2019 novel coronavirus pneumonia;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR);
- In compliance with the 2019-nCoV pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards): (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
Key exclusion criteria (11 listed)
- Patients with severe allergies or allergies to stem cells;
- Patients with serious basic diseases that affect survival, including: blood diseases, cachexia, active bleeding, severe malnutrition, etc.;
- Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia;
- Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
- In vitro life support (ECMO, ECCO2R, RRT);
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 |
|---|---|---|
| UC-MSCs0.5*10E6 UC-MSCs /kg body weight suspended in 100mL saline containing 1% human albumin intravenously at Day1, Day3, Day5, Day7 | Biological | UC-MSCs treatment group |
| Placebo100mL saline containing 1% human albumin intravenously at Day 1, Day 3, Day 5, Day 7 | Other | Control group |
Primary outcome
Size of lesion area by chest imaging
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Evaluation of Pneumonia change
Blood oxygen saturation
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Evaluation of Pneumonia change
8 secondary outcomes
Rate of mortality within 28-days
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Sequential organ failure assessment
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Side effects in the UC-MSCs treatment group
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Electrocardiogram, the changes of ST-T interval mostly
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of C-reactive protein C-reactive protein, immunoglobulin
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
CD4+ and CD8+ T cells count
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α)
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Concentration of the myocardial enzymes
Time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 UC-MSCs in people with COVID-19, run by Puren Hospital Affiliated to Wuhan 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 4 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: withdrawn, as of the sponsor's last update on 18 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Size of lesion area by chest imaging (time frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8). The study lists 2 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 18 Mar 2020.