Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

Phase 1

Not yet recruiting

• Conditions: COVID-19; ARDS; Acute Respiratory Distress Syndrome

• Registration Number: NCT04452097
• Lead Sponsor: Baylx Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-6-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female, aged between 18 and 80;<br><br> 2. Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19<br> pneumonia with mild to moderate ARDS (Berlin definition);<br><br> 3. Patients are intubated;<br><br> 4. Patients who voluntarily adhere to the research procedures and ensure good<br> compliance during the research period;<br><br> 5. Patients who fully understand the research nature of this study and sign written<br> informed consent.<br><br>Exclusion Criteria:<br><br> 1. Subjects who have received investigational drug (except for Remdesivir) for the<br> treatment of COVID-19 within 30 days before screening;<br><br> 2. Subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive<br> before participation in the study; subjects who are pregnant, breastfeeding, have a<br> birth plan, or are unwillingness to use contraception during the study period and<br> within 12 months of infusion; except for subjects who have sterilization surgery or<br> menopause during the study period;<br><br> 3. Within 3 days before screening/randomization, subjects who have used high-dose<br> corticosteroids that is equivalent to methylprednisolone >240 mg/day or irregular<br> use of systemic corticosteroids to treat other diseases that could affect the<br> efficacy evaluated by the investigator;<br><br> 4. Subjects receiving extracorporeal membrane oxygenation (ECMO) support.<br><br> 5. Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;<br><br> 6. Subjects with ongoing malignant tumors.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of infusion-related adverse events;Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

Secondary Outcome Measures

Name	Time	Method
Selection of an appropriate dose of BX-U001 for the following Phase 2 study;All-cause mortality;Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale.;Duration of ICU stay;Duration of hospital stay;Changes in blood cytokine levels