Covid-19 Clinical Trial
Official title:
The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | March 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19. 2. Patients who are willing to participate as subjects in the study by signing the informed content. 3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator: - PaO2 / FiO2: moderate 100-200 - PaO2 / FiO2: severe <100 4. One or more comorbid history 5. SOFA score Exclusion Criteria: 1. The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest) 2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death. 3. Severe NYHA III / IV heart failure 4. Pregnant women |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSUD Bantul | Bantul | Central Java |
Indonesia | RS Primaya Bekasi Timur | Bekasi | Jakarta |
Indonesia | Dr. Esnawan Antariksa Air Force Hospital | Jakarta | |
Indonesia | Gatot Soebroto Army Hospital | Jakarta | |
Indonesia | Bhayangkara Hospital | Makassar | South Celebes |
Indonesia | RS PKU Muhammadiyah Gamping | Yogyakarta | Central Java |
Lead Sponsor | Collaborator |
---|---|
Stem Cell and Cancer Research Indonesia | Provincial Government of Central Java, Indonesia |
Indonesia,
Chen L, Xu Y, Zhao J, Zhang Z, Yang R, Xie J, Liu X, Qi S. Conditioned medium from hypoxic bone marrow-derived mesenchymal stem cells enhances wound healing in mice. PLoS One. 2014 Apr 29;9(4):e96161. doi: 10.1371/journal.pone.0096161. eCollection 2014. Erratum in: PLoS One. 2015;10(12):e0145565. — View Citation
Haraszti RA, Miller R, Stoppato M, Sere YY, Coles A, Didiot MC, Wollacott R, Sapp E, Dubuke ML, Li X, Shaffer SA, DiFiglia M, Wang Y, Aronin N, Khvorova A. Exosomes Produced from 3D Cultures of MSCs by Tangential Flow Filtration Show Higher Yield and Improved Activity. Mol Ther. 2018 Dec 5;26(12):2838-2847. doi: 10.1016/j.ymthe.2018.09.015. Epub 2018 Sep 22. — View Citation
Harrell CR, Jovicic BP, Djonov V, Volarevic V. Therapeutic Potential of Mesenchymal Stem Cells and Their Secretome in the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome. Anal Cell Pathol (Amst). 2020 Nov 20;2020:1939768. doi: 10.1155/ — View Citation
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation
Johnson BS, Laloraya M. A cytokine super cyclone in COVID-19 patients with risk factors: the therapeutic potential of BCG immunization. Cytokine Growth Factor Rev. 2020 Aug;54:32-42. doi: 10.1016/j.cytogfr.2020.06.014. Epub 2020 Jul 1. Review. — View Citation
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in patients clinical manifestation | mild, moderate, or severe | 1 months | |
Primary | Need for a ventilator | There are respiratory variables that made severe Covid-19 patients previously stable but worsened, requiring a ventilator
Divided into two categories: It is necessary No need |
1 months | |
Primary | Duration of using a ventilator | Duration of use of a ventilator from the day of intubation to the day of extubation | 1 months | |
Primary | Length of stay | The length of stay from the first treatment to the patient's final outcome, recovery, or death | 1 months | |
Primary | Routine blood profile | Obtained from patients before and after treatment | 2 weeks | |
Primary | CRP | Obtained from patients before and after treatment | 2 weeks | |
Primary | D-dimer | Obtained from patients before and after treatment | 2 weeks | |
Primary | Blood Gas Analisis (BGA) | Obtained from patients before and after treatment | 2 weeks | |
Primary | Photo thorax | Obtained from patients before and after treatment | 2 weeks | |
Secondary | Survival | Death | 2 months |
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