Withdraw Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled trial

• Register: ChiCTR
• Last refreshed on: 28 September 2020
• Main ID: ChiCTR2000029569
• Date of registration: 2020-02-04
• Prospective Registration: Yes
• Primary sponsor: Xiangyang 1st People's Hospital
• Public title: Withdraw Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled trial
• Scientific title: Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled trial
• Date of first enrolment: 2020-02-05
• Target sample size: control group :15;Experimental group :15;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=49062
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Pei Bin
• Affiliation: Xiangyang 1st People's Hospital

• Name: Huang Guoxin
• Affiliation: Xiangyang 1st People's Hospital

Key inclusion & exclusion criteria

Inclusion criteria: On January 27, 2020, the general office of the national health commission and the office of the state administration of traditional Chinese medicine issued the pneumonia diagnosis and treatment plan for new coronavirus infection (trial version 4).
1. patients with severe 2019-ncov according to the clinical stage met any of the following criteria:
(1) Respiratory distress, RR>=30 times/min;
(2) In resting state, oxygen saturation is less than 93%;
(3) Partial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <=300mmHg (1mmHg= 0.133kpa);
2. according to the clinical stage of critical 2019-ncov, meet one of the following conditions:
(1) Respiratory failure occurs and mechanical ventilation is required;
(2) Shock;
(3) Combined with other organ failure, intensive care unit is required;
3. other inclusion criteria: good compliance, willingness to cooperate with the study, and informed consent signed by the patient.
Exclusion criteria: (1) diseases need to be differentiated from 2019-ncov, such as influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial pulmonary virus, SARS coronavirus and other known viral pneumonia, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia and non-infectious diseases;
(2) suspected case of 2019-ncov with no confirmed patient;
(3) the clinical stage was mild: the clinical symptoms were mild, and no pneumonia was observed on imaging;
(4) clinical stage: common type: fever, respiratory tract and other symptoms, and imaging findings of pneumonia;
(5) have any known disease that seriously affects the immune system, such as a history of infection with the human immunodeficiency virus (HIV), or malignant tumors of the blood system or solid organs, or splenectomy;
(6) other circumstances that the researcher considers inappropriate to participate in this study.

Age minimum: 18
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

novel coronavirus pneumonia (COVID-19)

Intervention(s)

control group :Conventional treatment ;Experimental group :conventional treatment combined with umbilical cord mesenchymal stem cell conditioned medium group;

Primary Outcome(s)

PSI;

Secondary Outcome(s)

CT;X-ray;Arterial blood gas analysis;Assisted breathing use time;mortality;Disease evolution;hospitalization day;Safety outcome index;

Source(s) of Monetary Support

funding

Ethics review

Status: Approved
Approval date: 04/02/2020
Contact:

He Jiwu