Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome

Post COVID-19 Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Visit 1 - Screening During the screening visit, the principal investigator and/or 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, he/she must sign it. By giving his/her signature, study subject allows the principal investigator and/or 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 Symptom's 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 and/or 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 Symptom's 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 4/Infusion 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 1/Phone 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 Symptom's and Fatigue Scale.

7. Physical Examination by the principal investigator.

8. Adverse Events monitoring. ;

Related Conditions & MeSH terms

• COVID-19
• Post COVID-19 Syndrome
• Syndrome

• NCT number: NCT04798066
• Study type: Expanded Access
• Source: Hope Biosciences
• Status: No longer available