Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04293692
• Date of registration: 24/02/2020
• Prospective Registration: Yes
• Primary sponsor: Puren Hospital Affiliated to Wuhan University of Science and Technology
• Public title: Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus
• Scientific title: Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus
• Date of first enrolment: February 24, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04293692
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

China

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female, 18 years old = age = 75years old;

2. CT image is characteristic of 2019 novel coronavirus pneumonia;

3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
chain reaction (RT-PCR);

4. 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);

Exclusion Criteria:

1. Patients with severe allergies or allergies to stem cells;

2. Patients with serious basic diseases that affect survival, including: blood diseases,
cachexia, active bleeding, severe malnutrition, etc.;

3. Patients with pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis,
alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or
bacterial pneumonia;

4. Continuous use of immunosuppressive agents or organ transplants in the past 6 months;

5. In vitro life support (ECMO, ECCO2R, RRT);

6. Expected deaths within 48 hours, uncontrolled infections;

7. Patients with malignant blood-borne diseases such as HIV or syphilis;

8. Patient with pregnancy, are planning to become pregnant or breastfeeding;

9. Patients with poor compliance and unable to complete the full study;

10. 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.);

11. There are other situations that the researchers think are not suitable to participate
in this clinical study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Other: Placebo

Biological: UC-MSCs

Primary Outcome(s)

Blood oxygen saturation [Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8]

Size of lesion area by chest imaging [Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8]

Secondary Outcome(s)

Concentration of C-reactive protein C-reactive protein, immunoglobulin [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]

Sequential organ failure assessment [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]

Concentration of the blood cytokine (IL-1ß, IL-6, IL-8,IL-10,TNF-a) [Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8]

Rate of mortality within 28-days [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]

Electrocardiogram, the changes of ST-T interval mostly [Time Frame: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8]

Secondary ID(s)

Pr20200225

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Wuhan Hamilton Bio-technology Co., Ltd