Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome

NCT05126563 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HBPCOVID02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.

Conditions

Post COVID-19 Syndrome

Outcome Measures

Primary Outcomes (42)

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Extreme fatigue. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Sleep disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model)

  Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model)

  Clinically significant changes in Visual Analog Scale. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure extreme fatigue has one end labeled "no fatigue" and the other end labeled "worst fatigue". The patient then marks a point on the line to indicate their current level of fatigue. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (fatigue).

  Baseline to Week 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model)

  Clinically significant changes in Visual Analog Scale - Brain fog. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure brain fog has one end labeled "no brain fog" and the other end labeled "worst brain fog". The patient then marks a point on the line to indicate their current level of brain fog. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (brain fog).

  Baseline to Week 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model)

  Clinically significant changes in Visual Analog Scale - Headache. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure Headache has one end labeled "no headache" and the other end labeled "worst headache". The patient then marks a point on the line to indicate their current level of Headache. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (headache).

  Baseline to Week 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model)

  Clinically significant changes in Visual Analog Scale - Sleep Disturbances. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure sleep disturbance has one end labeled "no sleep disturbance" and the other end labeled "worst sleep disturbance". The patient then marks a point on the line to indicate their current level of sleep disturbance. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (sleep disturbance).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model)

  Clinically significant changes in Visual Analog Scale - Loss of taste. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of taste has one end labeled "no loss of taste" and the other end labeled "worst loss of taste". The patient then marks a point on the line to indicate their current level of loss of taste. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of taste).

  Baseline to Weeks 26

• Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model)

  Clinically significant changes in Visual Analog Scale - Loss of smell. A VAS is a straight line with two end points that represent the extremes of a range. This VAS used to measure loss of smell has one end labeled "no loss of smell" and the other end labeled "worst loss of smell". The patient then marks a point on the line to indicate their current level of loss of smell. The minimum score is a 0 and the maximum score is a 10. A higher score indicates a worse outcome (loss of smell).

  Baseline to Weeks 26

• Changes in Laboratory Values. - CBC. (x10^3 Cells/uL)

  Clinically significant changes in CBC values.

  Baseline to Weeks 26

• Changes in Laboratory Values. - CBC. (% of WBC)

  Clinically significant changes in CBC values.

  Baseline to Weeks 26

• Changes in Laboratory Values. - CBC (pg)

  Changes from baseline in CBC laboratory values with unit of pg.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CBC (g/dL)

  Changes from baseline in CBC laboratory values with unit of g/dL.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CBC (fL)

  Changes from baseline in CBC laboratory values with unit of fL.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CBC (x10^6 Cells/uL)

  Changes from baseline in CBC laboratory values with unit of 10\^6 cells/uL.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC)

  Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CBC (% of Total Blood Cell Count)

  Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (g/dL)

  Clinically significant changes in CMP values.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds

  Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute)

  Clinically significant changes in Respiratory Rate (breaths per minute)

  Baseline to Weeks 26

• Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute)

  Clinically significant changes in Heart Rate (beats per minute)

  Baseline to Weeks 26

• Changes From Baseline in Vital Signs. - Body Temperature (Celsius)

  Clinically significant changes in Body Temperature (Celsius)

  Baseline to Week 10, End of Study at Weeks 26

• Changes in Vital Signs. - Blood Pressure (mmHg)

  Clinically significant changes in Blood Pressure.

  Baseline to Weeks 10, End of Study at Week 26

• Changes in Weight in kg.

  Change from baseline in Weight in kg.

  Baseline to Weeks 10, End of Study at Week 26

• Changes in Physical Examination Results. - Abdomen

  Clinically significant changes in physical examination results - Abdomen body system

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)

  Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (U/L)

  Clinically significant changes in CMP values with units of U/L.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (mg/dL)

  Clinically significant changes in CMP values with units of mg/dL.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (mEq/L)

  Clinically significant changes in CMP values with units of mEq/L.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (mL/Min/1.73m^2)

  Clinically significant changes in CMP values with units of mL/min/1.73m\^2.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio)

  Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Laboratory Values. - Coagulation Panel. (Seconds)

  Clinically significant changes in Coagulation Panel values with units of seconds.

  Baseline (Week 0), Week 10, and End of Study (Week 26)

• Changes in Physical Examination Results. - Cardiovascular

  Clinically significant changes in physical examination results - Cardiovascular body system

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat

  Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Lymph Node

  Clinically significant changes in physical examination results - Lymph Node

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Musculoskeletal

  Clinically significant changes in physical examination results - Musculoskeletal

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Neurological

  Clinically significant changes in physical examination results - Neurological

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Respiratory

  Clinically significant changes in physical examination results - Respiratory

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

• Changes in Physical Examination Results. - Skin

  Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system.

  Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26

Secondary Outcomes (9)

• Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model)

  Baseline (Infusion 1) to Weeks 26 (End of Study)

• Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea During Activity (ANCOVA Model)

  Baseline (Infusion 1) to Weeks 26 (End of Study)

• Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model)

  Baseline (Infusion 1) to Weeks 26 (End of Study)

• Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model)

  Baseline (Infusion 1) to Weeks 26 (End of Study)

• Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model)

  Baseline (Infusion 1) to Weeks 26 (End of Study)

Study Arms (2)

Treatment

ACTIVE COMPARATOR

HB-ad MSC's allogeneic

Biological: HB-adMSCs (allogeneic)

Placebo

PLACEBO COMPARATOR

Sterile Normal Saline

Other: Placebo

Interventions

HB-adMSCs (allogeneic) BIOLOGICAL

HB-adMSCs allogenic

Also known as: Hope Biosciences adipose derived mesenchymal stem cells

Treatment

Placebo OTHER

Placebo comarator

Also known as: Sterile Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants 18 - 70 years of age.
• \. Participants in the study have proof of Post COVID-19 Syndrome in their medical records.
• \. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial.
• \. The study participant is experiencing one or more neurological symptoms for at least 12 weeks, either continually or intermittently, with relapses not experienced pre-illness that interferes with regular daily activities. Symptoms must be new symptoms or dramatic worsening of preexisting symptoms, i.e., the subject didn't have symptoms and had not sought medical treatment for the symptoms before COVID-19, or the symptoms are dramatically worse (in severity and frequency). At least one symptom must have a severity of "5cm" on the neurological symptom VAS at screening. See the list of symptoms below:
• Extreme fatigue: Feeling overtired with low energy and a strong desire to sleep.
• Brain Fog: A diminished mental capacity marked by the inability to concentrate, think or reason clearly interferes with daily activities.
• Headache: Sharp or dull reoccurring or intermittent that were not present pre-illness.
• Sleep Issues: Any sleep disturbances in sleep quality that makes sleep seem inadequate or unrefreshing like insomnia or hypersomnia.
• Loss of Taste/Smell: A diminished sense of taste or smell.
• \. Study participants should be able to read, understand, and provide written consent.
• \. Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration.
• \. If their sexual partners can become pregnant, male participants should use a method of contraception during study participation and for six months after the last administration of the experimental drug. \*
• \. The study participant is able and willing to comply with the requirements of this clinical trial.

You may not qualify if:

• The subject is unable to provide informed consent or to comply with study requirements.
• A study participant has currently been diagnosed with active COVID-19 disease, defined as ongoing symptoms related to acute infection (such as fever or chills, cough, shortness of breath, or difficulty breathing, among other symptoms), and evidence of a positive RT-PCR SARS- CoV-2.
• The subject is unwilling to agree to the use of acceptable methods of contraception \* throughout the study and for six months after the last dose of the investigational product.
• Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take adequate contraceptive measures. \*
• The study participant has a history of addiction or dependency, or he or she is currently abusing or using substances.
• Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
• The study participant has one or more significant concurrent medical conditions (verified by medical records), including the following:
• Diabetes Mellitus (DM) Poorly controlled diabetes mellitus (PCDM), defined as a history of deficient standard of care treatment or pre-prandial glucose \>130mg/dl during screening visit or post-prandial glucose \>200mg/dl.
• Chronic kidney disease (CKD): Medical History of Chronic kidney disease (CKD) diagnosis or screening results of eGFR \< 59mL/min/1.73m2. Subjects with any form of kidney dialysis will be excluded from participation in this clinical trial.
• Heart Failure Presence of New York Heart Association (NYHA) Class III/IV heart failure during the screening visit.
• Myocardial Infarction: Medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina.
• High Blood Pressure: Medical history of uncontrolled high blood pressure is defined as a deficient standard of care treatment or blood pressure \> 140/90 mm/Hg during the screening visit in a patient taking anti-hypertensive treatment. At screening visit, all patients must have a blood pressure \<140/90 mmHg.
• Other diseases: Medical history of inherited thrombophilias, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach).
• Other conditions: Lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur or recent major general surgery (within 12 months before the Screening).
• Study participant has received any stem cell treatment within 12 months before the first dose of the investigational product other than stem cells produced by Hope Biosciences.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ridhima Vij, PhD
• Organization: Hope Biosciences Research Foundation

ridhima@hopebio.org

346-900-0340

Study Officials

• Thanh Cheng, MD

  Hope Biosciences Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Amber bags will be used to 'blind' the participant and investigator to which group the subject belongs in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Double-Blind

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 19, 2021
• Study Start: February 2, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: September 26, 2025
• Results First Posted: November 26, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)