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Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331613
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Beijing YouAn Hospital
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences

Brief Summary:
A phase1/2, open label, dose escalation, safety and early efficacy study of CAStem for the treatment of severe COVID-19 associated with or without ARDS.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Virus; Pneumonia Acute Lung Injury Biological: CAStem Phase 1 Phase 2

Detailed Description:
CAStem is an injectable product composed of immunity- and matrix-regulatory cells (IMRCs), also named M cells, differentiated from clinical-grade human embryonic stem cells (hESCs) will be expanded, harvested, and formulated at a concentration of 50 x 10^6 cells/mL. CAStem will be cryopreserved and transported to clinical site using liquid nitrogen vapor shipping vessels (< -150ºC). Prior to injection, CAStem will be thawed to liquefy quickly, and then reconstituted in normal saline.In the present study, the intravenous infusion dose of CAStem will be 3, 5 or 10 million cells/kg.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Human Embryonic Stem Cells Derived M Cells (CAStem) for the Treatment of Severe COVID-19 Associated With or Without Acute Respiratory Distress Syndrome (ARDS)
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: CAStem
A dose-escalation with 3 cohorts with 3 patients/cohort who receive doses of 3, 5 or 10 million cells/kg. If there is no safety concerns for each cohort, the dose will be escalated from lower dose to next higher dose.
Biological: CAStem
CAStem will be administered intravenously.




Primary Outcome Measures :
  1. Adverse reaction (AE) and severe adverse reaction (SAE) [ Time Frame: Within 28 days after treatment ]
    Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment

  2. Changes of lung imaging examinations [ Time Frame: Within 28 days after treatment ]
    Evaluation by chest CT


Secondary Outcome Measures :
  1. Time to SARS-CoV-2 RT-PCR negative [ Time Frame: Within 28 days after treatment ]
    Marker for SARS-CoV-2

  2. Duration of fever (Celsius) [ Time Frame: Within 28 days after treatment ]
    The duration of a fever above 37.3 degrees Celsius

  3. Changes of blood oxygen (%) [ Time Frame: Within 28 days after treatment ]
    Marker for efficacy

  4. Rate of all-cause mortality within 28 days [ Time Frame: Within 28 days after treatment ]
    Marker for efficacy

  5. Lymphocyte count (*10^9/L) [ Time Frame: Within 28 days after treatment ]
    Counts of lymphocyte in a litre (L) of blood

  6. Alanine aminotransferase (U/L) [ Time Frame: Within 28 days after treatment ]
    Alanine aminotransferase in unit (U)/litre(L)

  7. Creatinine (umol/L) [ Time Frame: Within 28 days after treatment ]
    Creatinine in micromole (umol)/litre(L)

  8. Creatine kinase (U/L) [ Time Frame: Within 28 days after treatment ]
    Creatine kinase in U/L

  9. C-reactive protein (mg/L) [ Time Frame: Within 28 days after treatment ]
    C-reactive in microgram (mg)/litre(L)

  10. Procalcitonin (ng/L) [ Time Frame: Within 28 days after treatment ]
    Procalcitonin in nanogram (ng)/litre(L)

  11. Lactate (mmol/L) [ Time Frame: Within 28 days after treatment ]
    Lactate in millimole(mmol)/litre(L)

  12. IL-1beta (pg/mL) [ Time Frame: Within 28 days after treatment ]
    IL-1beta in picogram(pg)/millilitre(mL)

  13. IL-2 (pg/mL) [ Time Frame: Within 28 days after treatment ]
    IL-2 in pg/mL

  14. IL-6 (pg/mL) [ Time Frame: Within 28 days after treatment ]
    IL-6 in pg/mL

  15. IL-8 (pg/mL) [ Time Frame: Within 28 days after treatment ]
    IL-8 in pg/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Chinese patients, aged 18 to 70 years old, males or females;
  2. Diagnosis of COVID-19, and confirm by chest CT scan;
  3. According to the diagnosis and treatment plan for the novel coronavirus disease (COVID-19) (trial version 5) issued by the National Health Commission (NHC) on the diagnostic criteria for severe or critical ill COVID-19 patients including the patients with acute respiratory distress syndrome (ARDS), the specific diagnostic criteria are:

    Severely ill patients should meet all of the following:

    • 1. Respiratory distress, RR ≥ 30 times/min.
    • 2. In a resting state (without oxygen supplementation), oxygen saturation ≤ 93%.
    • 3. Partial arterial oxygen pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300 mmHg (1 mmHg = 0.133 kpa). High altitude (above sea level 1000 m) area should be calibrated for PaO2/FiO2 according to the following method: PaO2/FiO2*[atmospheric pressure (mmHg)/760]. Patients with obvious progress in lung lesions by chest CT within 24-48 hours should be counted as the server cases.

    Critically ill patients should meet one of the following :

    • 1. Respiratory failure, the mechanical ventilation required.
    • 2. Shock.
    • 3. Associated with other organ failure, ICU needed for monitoring and management.
  4. Voluntarily participate in the study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.

Exclusion criteria:

  1. Patients with a history of transplantation of cells or organ(s).
  2. Patients with a history of malignancy or pathology indicating severe atypical hyperplasia.
  3. Patients without life expectancy of 48 hours.
  4. Patients with moderate to severe liver failure (Childs Pugh scores > 12).
  5. Patients with cardiogenic pulmonary edema.
  6. Patients with a history of deep vein thrombosis or pulmonary embolism within 3 months before the screening.
  7. Patients with severe chronic pulmonary diseases, including but not restricted to the patients with WHO grade III or IV pulmonary hypertension or those with chronic pulmonary diseases requiring long-term oxygen therapy.
  8. Patients with unstable ventricular tachycardia or ventricular fibrillation.
  9. Patients with poor coagulation, severe bleeding tendency or active bleeding at present.
  10. Patients with serious dysfunction involved in the major organs or systems (liver, kidney, gastrointestinal, cardiovascular, blood coagulation, central system, etc.) besides the respiratory system are not suitable to participate in the present study.
  11. Patients with a history of severe conditions in any organs or systems.
  12. Patients who are unable to accept other invasive rescue except cardiopulmonary resuscitation.
  13. Patients who are allergic to the main active ingredients or excipients of the investigational drug.
  14. Women who are pregnant, breastfeeding or planning to become pregnant during the study period. Woman of childbearing age who is not willing to use appropriate contraceptive methods through the completion of the clinical study.
  15. Patients whose participation is considered to bring significant risks to the present clinical study, cause confusion in analysis, or significantly interfere with the clinical research results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331613


Contacts
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Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn

Locations
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China, Beijing, China
Beijing YouAn Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, China, 100000
Sponsors and Collaborators
Chinese Academy of Sciences
Beijing YouAn Hospital
Investigators
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Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences
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Responsible Party: Qi Zhou, Director, Institute of Zoology, Chinese Academy of sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT04331613    
Other Study ID Numbers: ChineseASZQ-006
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qi Zhou, Chinese Academy of Sciences:
CAStem
Stem Cells
Cell Therapy
IMRCs
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Virus Diseases