Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04452097
Other study ID # BXU001-COVID19
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2023
Est. completion date May 31, 2024

Study information

Verified date August 2022
Source Baylx Inc.
Contact Vincent Liao, MD. Ph.D.
Phone 949-308-1952
Email baylx@baylxinc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date May 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Male or female, aged between 18 and 80; 2. Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19 pneumonia with mild to moderate ARDS (Berlin definition); 3. Patients are intubated; 4. Patients who voluntarily adhere to the research procedures and ensure good compliance during the research period; 5. Patients who fully understand the research nature of this study and sign written informed consent. Exclusion Criteria: 1. Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening; 2. Subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive before participation in the study; subjects who are pregnant, breastfeeding, have a birth plan, or are unwillingness to use contraception during the study period and within 12 months of infusion; except for subjects who have sterilization surgery or menopause during the study period; 3. Within 3 days before screening/randomization, subjects who have used high-dose corticosteroids that is equivalent to methylprednisolone >240 mg/day or irregular use of systemic corticosteroids to treat other diseases that could affect the efficacy evaluated by the investigator; 4. Subjects receiving extracorporeal membrane oxygenation (ECMO) support. 5. Subjects who are allergic to low-molecular-weight heparin calcium or human albumin; 6. Subjects with ongoing malignant tumors.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Human umbilical cord mesenchymal stem cells + best supportive care
hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Other:
Placebo control + best supportive care
Placebo control will be administered intravenously in addition to the standard of care treatment.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Baylx Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of infusion-related adverse events Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician Day 3
Primary Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician Day 28
Secondary Selection of an appropriate dose of BX-U001 for the following Phase 2 study The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose. Day 28
Secondary All-cause mortality Day 28
Secondary Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care 7. Not hospitalized. Day 14
Secondary Duration of ICU stay Day 28
Secondary Duration of hospital stay Day 28
Secondary Changes in blood cytokine levels Day 28
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure