Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus

NCT04293692 | Withdrawn DMC

• 1 other identifier: Pr20200225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Size of lesion area by chest imaging

  Evaluation of Pneumonia change

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Blood oxygen saturation

  Evaluation of Pneumonia change

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Secondary Outcomes (8)

• Rate of mortality within 28-days

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Sequential organ failure assessment

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Side effects in the UC-MSCs treatment group

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Electrocardiogram, the changes of ST-T interval mostly

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

• Concentration of C-reactive protein C-reactive protein, immunoglobulin

  At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Study Arms (2)

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).

Biological: UC-MSCs

Control group

PLACEBO COMPARATOR

Participants will receive conventional treatment plus 4 times of Placebo intravenously at Day1, Day3, Day5, Day7.

Other: Placebo

Interventions

UC-MSCs BIOLOGICAL

0.5\*10E6 UC-MSCs /kg body weight suspended in 100mL saline containing 1% human albumin intravenously at Day1, Day3, Day5, Day7

UC-MSCs treatment group

Placebo OTHER

100mL saline containing 1% human albumin intravenously at Day 1, Day 3, Day 5, Day 7

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Puren Hospital Affiliated to Wuhan University of Science and Technology: lead
• Wuhan Hamilton Bio-technology Co., Ltd: collaborator

Study Sites (1)

Puren Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, 430081, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 3, 2020
• Study Start: February 24, 2020
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)