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

Phase 1

• Conditions: Acute Respiratory Distress Syndrome; Virus; Pneumonia; Acute Lung Injury; COVID-19
• Interventions: Biological: CAStem

• Registration Number: NCT04331613
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-27
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-03-31
• Last Update Submitted: 2020-03-31
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAStem	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.

Primary Outcome Measures

Name	Time	Method
Adverse reaction (AE) and severe adverse reaction (SAE)	Within 28 days after treatment	Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
Changes of lung imaging examinations	Within 28 days after treatment	Evaluation by chest CT

Secondary Outcome Measures

Name	Time	Method
IL-8 (pg/mL)	Within 28 days after treatment	IL-8 in pg/mL
Lymphocyte count (*10^9/L)	Within 28 days after treatment	Counts of lymphocyte in a litre (L) of blood
Creatinine (umol/L)	Within 28 days after treatment	Creatinine in micromole (umol)/litre(L)
Creatine kinase (U/L)	Within 28 days after treatment	Creatine kinase in U/L
Duration of fever (Celsius)	Within 28 days after treatment	The duration of a fever above 37.3 degrees Celsius
IL-2 (pg/mL)	Within 28 days after treatment	IL-2 in pg/mL
Rate of all-cause mortality within 28 days	Within 28 days after treatment	Marker for efficacy
Time to SARS-CoV-2 RT-PCR negative	Within 28 days after treatment	Marker for SARS-CoV-2
Alanine aminotransferase (U/L)	Within 28 days after treatment	Alanine aminotransferase in unit (U)/litre(L)
Lactate (mmol/L)	Within 28 days after treatment	Lactate in millimole(mmol)/litre(L)
IL-1beta (pg/mL)	Within 28 days after treatment	IL-1beta in picogram(pg)/millilitre(mL)
Changes of blood oxygen (%)	Within 28 days after treatment	Marker for efficacy
C-reactive protein (mg/L)	Within 28 days after treatment	C-reactive in microgram (mg)/litre(L)
Procalcitonin (ng/L)	Within 28 days after treatment	Procalcitonin in nanogram (ng)/litre(L)
IL-6 (pg/mL)	Within 28 days after treatment	IL-6 in pg/mL

Trial Locations

Locations (1)

Beijing YouAn Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China, China