Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798066
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-05-03
First Post:
2021-03-11
Brief Title:
Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome
Sponsor:
Hope Biosciences Stem Cell Research Foundation
Organization:
Hope Biosciences
Study Overview
Official Title:
Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Patients With Post-COVID-19 Syndrome
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an Intermediate- Size Patient Population Expanded Access Protocol to evaluate the safety and efficacy of HB-adMSCs for the treatment of patients with Post-COVID-19 Syndrome The investigational product will be an add-on treatment to the standard of care
Detailed Description:
Visit 1 - Screening During the screening visit the principal investigator andor delegated staff must provide a copy of the IRB-approved informed consent form to the subject before performing any study procedure
IRB must provide a certificate action as proof of approval of the informed consent form
The study subject should take enough time to read this essential document If the study subject agrees to participate in the clinical trial after reading the document heshe must sign it By giving hisher signature study subject allows the principal investigator andor designated staff to perform the following study procedures
1 Collection of medical history and demographic information
2 Collection of prior up to a week before screening and current medications
3 Evaluation of Inclusion and Exclusion Criteria
4 Measurement of Weight in lb and Height in inches
5 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
6 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein and Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential
7 Completion of Patient Questionnaires VAS of Symptoms and Fatigue Scale
8 Physical Examination by the principal investigator
9 Adverse Events Monitoring Within a 28-day period all screening data should be collected and analyzed and the principal investigator must decide whether the screened subject is eligible to participate in this Intermediate- Size Patient Population Expanded Access Protocol
Visit 2 3 4 5 and 6 Infusions 1 2 3 4 and 5 Throughout these visits the principal investigator andor delegated staff will perform the following assessments
1 Pre-Infusion Check List
2 Update Medical History Form if necessary
3 Update Concomitant medications list if applicable no premedication necessary for the infusions
4 Measurement of Weight in lb
5 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
6 Completion VAS of Symptoms and Fatigue Scale
7 Physical Examination by the principal investigator
8 Investigational Product Administration
Drug Name HB-adMSCs
Route Intravenous
Dose 200 million
9 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events
10 Adverse Events monitoring
At Visit 4Infusion 3 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein Erythrocyte sedimentation rate urine pregnancy test female of childbearing potential and Patient Questionnaire
Visit 7 Follow up 1Phone call
1 Update Medical History Form if necessary
2 Update Concomitant medications list if applicable
3 Adverse Events monitoring
Visit 8 End of Study
1 Update Medical History Form if necessary
2 Update Concomitant medications list if applicable
3 Measurement of Weight in lb
4 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
5 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential
6 Completion of Patient Questionnaires VAS of Symptoms and Fatigue Scale
7 Physical Examination by the principal investigator
8 Adverse Events monitoring
IRB must provide a certificate action as proof of approval of the informed consent form
The study subject should take enough time to read this essential document If the study subject agrees to participate in the clinical trial after reading the document heshe must sign it By giving hisher signature study subject allows the principal investigator andor designated staff to perform the following study procedures
1 Collection of medical history and demographic information
2 Collection of prior up to a week before screening and current medications
3 Evaluation of Inclusion and Exclusion Criteria
4 Measurement of Weight in lb and Height in inches
5 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
6 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein and Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential
7 Completion of Patient Questionnaires VAS of Symptoms and Fatigue Scale
8 Physical Examination by the principal investigator
9 Adverse Events Monitoring Within a 28-day period all screening data should be collected and analyzed and the principal investigator must decide whether the screened subject is eligible to participate in this Intermediate- Size Patient Population Expanded Access Protocol
Visit 2 3 4 5 and 6 Infusions 1 2 3 4 and 5 Throughout these visits the principal investigator andor delegated staff will perform the following assessments
1 Pre-Infusion Check List
2 Update Medical History Form if necessary
3 Update Concomitant medications list if applicable no premedication necessary for the infusions
4 Measurement of Weight in lb
5 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
6 Completion VAS of Symptoms and Fatigue Scale
7 Physical Examination by the principal investigator
8 Investigational Product Administration
Drug Name HB-adMSCs
Route Intravenous
Dose 200 million
9 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events
10 Adverse Events monitoring
At Visit 4Infusion 3 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein Erythrocyte sedimentation rate urine pregnancy test female of childbearing potential and Patient Questionnaire
Visit 7 Follow up 1Phone call
1 Update Medical History Form if necessary
2 Update Concomitant medications list if applicable
3 Adverse Events monitoring
Visit 8 End of Study
1 Update Medical History Form if necessary
2 Update Concomitant medications list if applicable
3 Measurement of Weight in lb
4 Collection of vital signs including respiratory rate pulse rate SPO2 blood pressure and body temperature
5 Collection of laboratory samples including Comprehensive Metabolic Panel Complete Blood Count and Coagulation Panel C - reactive protein Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential
6 Completion of Patient Questionnaires VAS of Symptoms and Fatigue Scale
7 Physical Examination by the principal investigator
8 Adverse Events monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None