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

NCT04331613 | Unknown Phase 1 DMC

• 1 other identifier: ChineseASZQ-006
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Acute Respiratory Distress Syndrome; Virus; Pneumonia; Acute Lung Injury

Keywords

CAStem; Stem Cells; Cell Therapy; IMRCs

Outcome Measures

Primary Outcomes (2)

• Adverse reaction (AE) and severe adverse reaction (SAE)

  Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment

  Within 28 days after treatment

• Changes of lung imaging examinations

  Evaluation by chest CT

  Within 28 days after treatment

Secondary Outcomes (15)

• Time to SARS-CoV-2 RT-PCR negative

  Within 28 days after treatment

• Duration of fever (Celsius)

  Within 28 days after treatment

• Changes of blood oxygen (%)

  Within 28 days after treatment

• Rate of all-cause mortality within 28 days

  Within 28 days after treatment

• Lymphocyte count (*10^9/L)

  Within 28 days after treatment

Study Arms (1)

CAStem

EXPERIMENTAL

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

Interventions

CAStem BIOLOGICAL

CAStem will be administered intravenously.

CAStem

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese patients, aged 18 to 70 years old, males or females;
• Diagnosis of COVID-19, and confirm by chest CT scan;
• 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:
• \. Respiratory distress, RR ≥ 30 times/min.
• \. In a resting state (without oxygen supplementation), oxygen saturation ≤ 93%.
• \. 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 :
• \. Respiratory failure, the mechanical ventilation required.
• \. Shock.
• \. Associated with other organ failure, ICU needed for monitoring and management.
• Voluntarily participate in the study, agree to comply with the requirements of the clinical trial protocol, and sign the informed consent.

You may not qualify if:

• Patients with a history of transplantation of cells or organ(s).
• Patients with a history of malignancy or pathology indicating severe atypical hyperplasia.
• Patients without life expectancy of 48 hours.
• Patients with moderate to severe liver failure (Childs Pugh scores \> 12).
• Patients with cardiogenic pulmonary edema.
• Patients with a history of deep vein thrombosis or pulmonary embolism within 3 months before the screening.
• 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.
• Patients with unstable ventricular tachycardia or ventricular fibrillation.
• Patients with poor coagulation, severe bleeding tendency or active bleeding at present.
• 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.
• Patients with a history of severe conditions in any organs or systems.
• Patients who are unable to accept other invasive rescue except cardiopulmonary resuscitation.
• Patients who are allergic to the main active ingredients or excipients of the investigational drug.
• 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.
• 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.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Beijing YouAn Hospital: collaborator

Study Sites (1)

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing, China, 100000, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Pneumonia, Viral; Acute Lung Injury

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Zhou Qi, Doctor

  Institute of Zoology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Liu, Doctor

CONTACT

+86-01064807858; wangliu@ioz.ac.cn

Hao Jie, Doctor

CONTACT

+86-01062558737; haojie@ioz.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Zoology, Chinese Academy of sciences

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: April 2, 2020
• Study Start: January 27, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-01

Locations

CN (1)