Post COVID-19 SyndromePhase 2HBPCOVID02NCT05126563
Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome
A Phase 2 study testing HB-adMSCs (allogeneic) in people with Post COVID-19 Syndrome, run by Hope Biosciences Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post COVID-19 Syndrome
- What is being tested?
- HB-adMSCs (allogeneic)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 2 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A study participant will be eligible for inclusion in this study only if all the following criteria apply:
- 1 Male and female participants 18 - 70 years of age.
- 2. Participants in the study have proof of Post COVID-19 Syndrome in their medical records.
- 3. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial.
- 4. 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.
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- 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.
- 5. Study participants should be able to read, understand, and provide written consent.
- 6. Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration.
- 7. 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.
- 8. The study participant is able and willing to comply with the requirements of this clinical trial.
Who cannot join
- A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
- 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.
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- 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.
- The study participant has received an experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
- Study participant has a laboratory abnormality during screening, including the following:
- White blood cell count WBC < 3.0 K/UL and > 12.0 K/UL
- Platelet count < 80 K/UL and or > 450 K/UL
- Absolute neutrophil count < 1.50 K/UL and or > 7.50 K/UL
- Alanine aminotransferase (ALT) of > 75 U/L
- Aspartate aminotransferase (AST) of > 75 U/L
- Hemoglobin (Hgb) <11 G/DL or >18 G/DL
- Hematocrit (HCT) <33% or >54 %
- Mean corpuscular volume (MCV) < 75 FL or >100 FL
- Mean corpuscular hemoglobin (MCH) <23 PG or >36 PG
- Mean corpuscular hemoglobin concentration (MCHC) <30 G/DL or > 37gG/DL
- Red cell distribution width (RDW) < 10% or >14%
- Abnormal laboratory results considered clinically significant by the principal investigator will exclude patients from participation in this investigation.
- The study participant has any known ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, syphilis infections, hepatitis B surface antigen-positive, or hepatitis C PCR positivity.
- The study participant is unlikely to complete the study or adhere to the study procedures.
- The study participant has a previously diagnosed psychiatric condition that may affect self-assessments in the investigator's opinion.
- Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days before the first dose of the investigational product.
- Male study participants expect to donate sperm during the trial or within six months after the last dose. Female patients intend to donate eggs or have IVF treatment during the trial or within six months after the last dose.
- Study participants who the Investigator determines to be unsuitable for study enrollment for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, those who have a prothrombotic condition, or who require persistent oxygen supplementation.
- The subject has recently been diagnosed with an unstable Chronic obstructive pulmonary disease (COPD) as defined by patients who experience frequent or severe exacerbations and a faster decline in pulmonary function.
- Subjects who have fatigue due to chronic kidney disease, iron deficiency anemia, B12 deficiency and other anemias will be excluded.
- Any participant who has suicidal ideation at the screening visit will be excluded from this clinical trial.
- Subjects with the following diseases must be excluded from participation in the trial.
- chronic liver disease
- pneumonia
- history of chronic fatigue syndrome
- subjects with fatigue symptoms due to fibromyalgia, arthritic disorders, inflammatory and rheumatological disorders
- respiratory failure
- emphysema
- uncontrolled asthma
- any subject requiring supplemental oxygen for any cause.
- Acceptable reversible and permanent methods of birth control include:
- 1. True sexual abstinence (abstaining from sexual activity during the entire period of risk).
- 2. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS). 5. Condoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Research Foundation
Sugar Land, Texas, 77478
About this study
Official title: A Randomized, Double-blinded, Single-center, Phase 2 Efficacy, and Safety Study of Allogeneic HB-adMSCs for the Treatment of Patients With Chronic Post-COVID-19 Syndrome.
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.
Read the detailed description
Active Product: HB- adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells - allogeneic) Dose: 200 million Route: Intravenous Regimen: Weeks 0, 2, 6, and 10. Placebo: Saline Solution 0.9% Dose: N/A Route: Intravenous Regimen: Weeks 0, 2, 6, and 10.Duration of administration 1 hour Laboratory Samples. Screening, Week 0, 6, and 26. Visits by Weeks Screening Week 0 - Infusion 1 Week 2 - Infusion 2 Week 6 - Infusion 3 Week 10 - Infusion 4 Week 14 - Follow Up 1 Week 20 - Follow Up 2 Week 26 - End of Study
- Conditions
- Post COVID-19 Syndrome
- Being tested
- HB-adMSCs (allogeneic), Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCs (allogeneic)Biological
Also called Hope Biosciences adipose derived mesenchymal stem cells
HB-adMSCs allogenic
PlaceboOther
Also called Sterile Normal Saline
Placebo comarator
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | HB-ad MSC's allogeneic Receives: Biological: HB-adMSCs (allogeneic) |
| Placebo | Placebo comparator | Sterile Normal Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline to Weeks 26
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL)
Clinically significant changes in CBC values.
Measured: Baseline to Weeks 26
Changes in Laboratory Values. - CBC. (% of WBC)
Clinically significant changes in CBC values.
Measured: Baseline to Weeks 26
Changes in Laboratory Values. - CBC (pg)
Changes from baseline in CBC laboratory values with unit of pg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes in Laboratory Values. - CMP (g/dL)
Clinically significant changes in CMP values.
Measured: 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).
Measured: 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)
Measured: Baseline to Weeks 26
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute)
Clinically significant changes in Heart Rate (beats per minute)
Measured: Baseline to Weeks 26
Changes From Baseline in Vital Signs. - Body Temperature (Celsius)
Clinically significant changes in Body Temperature (Celsius)
Measured: Baseline to Week 10, End of Study at Weeks 26
Changes in Vital Signs. - Blood Pressure (mmHg)
Clinically significant changes in Blood Pressure.
Measured: Baseline to Weeks 10, End of Study at Week 26
Changes in Weight in kg.
Change from baseline in Weight in kg.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Clinically significant changes in Visual Analog Scale - Dyspnea at rest. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea).
Measured: 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)
Clinically significant changes in Visual Analog Scale - Dyspnea during activity. Score ranges from 0 points (no dyspnea) to 10 points (maximum amount of dyspnea)
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Cough. Score ranges from 0 points (no cough) to 10 points (maximum amount of cough).
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Body aches. Score ranges from 0 points (no body aches) to 10 points (maximum amount of body aches).
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model)
Clinically significant changes in Visual Analog Scale - Joint Pain. Score ranges from 0 points (no pain) to 10 points (maximum amount of pain).
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model)
Clinically significant changes in Fatigue Assessment form. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health)
Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability.
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Level of Depression - PHQ 9 Scale.
Clinically significant changes in PHQ (Patient health questionnaire) 9 scale. The PHQ-9 is a 9 question assessment with a total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression) [30].
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score)
Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability.
Measured: Baseline (Infusion 1) to Weeks 26 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start2 Feb 2022
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-Blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thanh Cheng, MD, Principal investigator, Hope Biosciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126563
- Sponsor's protocol ID
- HBPCOVID02
- Acronym
- HBPCOVID02
- Status last verified
- Sep 2025
- First submitted
- 12 Nov 2021
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Single-center, Phase 2 Efficacy, and Safety Study of Allogeneic HB-adMSCs for the Treatment of Patients With Chronic Post-COVID-19 Syndrome.
- ClinicalTrials.gov ID
- NCT05126563
- Acronym / sponsor ID
- HBPCOVID02 / HBPCOVID02
- Conditions
- Post COVID-19 Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Active Product: HB- adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells - allogeneic) Dose: 200 million Route: Intravenous Regimen: Weeks 0, 2, 6, and 10. Placebo: Saline Solution 0.9% Dose: N/A Route: Intravenous Regimen: Weeks 0, 2, 6, and 10.Duration of administration 1 hour Laboratory Samples. Screening, Week 0, 6, and 26. Visits by Weeks Screening Week 0 - Infusion 1 Week 2 - Infusion 2 Week 6 - Infusion 3 Week 10 - Infusion 4 Week 14 - Follow Up 1 Week 20 - Follow Up 2 Week 26 - End of Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized Double-Blind
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Biological: HB-adMSCs (allogeneic)HB-ad MSC's allogeneic |
| Placebo | Placebo comparator | Other: PlaceboSterile Normal Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A study participant will be eligible for inclusion in this study only if all the following criteria apply:
- 1 Male and female participants 18 - 70 years of age.
- 2. Participants in the study have proof of Post COVID-19 Syndrome in their medical records.
- 3. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial.
- 4. 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:
Key exclusion criteria (51 listed)
- A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
- 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. *
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-adMSCs (allogeneic)Also: Hope Biosciences adipose derived mesenchymal stem cellsHB-adMSCs allogenic | Biological | Treatment |
| PlaceboAlso: Sterile Normal SalinePlacebo comarator | Other | Placebo |
Primary outcome
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (ANCOVA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms - Extreme Fatigue (RMA Model)
Time frame: Baseline to Week 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms.. - Brain Fog (RMA Model)
Time frame: Baseline to Week 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Headache (RMA Model)
Time frame: Baseline to Week 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Sleep Disturbances (RMA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Taste (RMA Model)
Time frame: Baseline to Weeks 26
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).
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Loss of Smell (RMA Model)
Time frame: Baseline to Weeks 26
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).
Changes in Laboratory Values. - CBC. (x10^3 Cells/uL)
Time frame: Baseline to Weeks 26
Clinically significant changes in CBC values.
Changes in Laboratory Values. - CBC. (% of WBC)
Time frame: Baseline to Weeks 26
Clinically significant changes in CBC values.
Changes in Laboratory Values. - CBC (pg)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit of pg.
Changes in Laboratory Values. - CBC (g/dL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit of g/dL.
Changes in Laboratory Values. - CBC (fL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit of fL.
Changes in Laboratory Values. - CBC (x10^6 Cells/uL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit of 10^6 cells/uL.
Changes in Laboratory Values. - CBC (% Difference in Volume and Size of RBC)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit % Difference in Volume and Size of RBC
Changes in Laboratory Values. - CBC (% of Total Blood Cell Count)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CBC laboratory values with unit of % of Total Blood Cell Count.
Changes in Laboratory Values. - CMP (g/dL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values.
Changes in Laboratory Values. - Coagulation Panel. Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in Coagulation Panel values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Changes From Baseline in Vital Signs. - Respiratory Rate (Breaths Per Minute)
Time frame: Baseline to Weeks 26
Clinically significant changes in Respiratory Rate (breaths per minute)
Changes From Baseline in Vital Signs. - Heart Rate (Beats Per Minute)
Time frame: Baseline to Weeks 26
Clinically significant changes in Heart Rate (beats per minute)
Changes From Baseline in Vital Signs. - Body Temperature (Celsius)
Time frame: Baseline to Week 10, End of Study at Weeks 26
Clinically significant changes in Body Temperature (Celsius)
Changes in Vital Signs. - Blood Pressure (mmHg)
Time frame: Baseline to Weeks 10, End of Study at Week 26
Clinically significant changes in Blood Pressure.
Changes in Weight in kg.
Time frame: Baseline to Weeks 10, End of Study at Week 26
Change from baseline in Weight in kg.
Changes in Physical Examination Results. - Abdomen
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Abdomen body system
Changes in Laboratory Values. - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Changes in Laboratory Values. - CMP (U/L)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values with units of U/L.
Changes in Laboratory Values. - CMP (mg/dL)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values with units of mg/dL.
Changes in Laboratory Values. - CMP (mEq/L)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values with units of mEq/L.
Changes in Laboratory Values. - CMP (mL/Min/1.73m^2)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values with units of mL/min/1.73m^2.
Changes in Laboratory Values. - CMP (Calc BUN mg/dL /Creat mg/dL Ratio)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in CMP values with units of Calc BUN mg/dL /Creat mg/dL Ratio
Changes in Laboratory Values. - Coagulation Panel. (Seconds)
Time frame: Baseline (Week 0), Week 10, and End of Study (Week 26)
Clinically significant changes in Coagulation Panel values with units of seconds.
Changes in Physical Examination Results. - Cardiovascular
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Cardiovascular body system
Changes in Physical Examination Results. - Head, Eyes, Ears, Nose, and Throat
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Head, Eyes, Ears, Nose, and Throat body system
Changes in Physical Examination Results. - Lymph Node
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Lymph Node
Changes in Physical Examination Results. - Musculoskeletal
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Musculoskeletal
Changes in Physical Examination Results. - Neurological
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Neurological
Changes in Physical Examination Results. - Respiratory
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Respiratory
Changes in Physical Examination Results. - Skin
Time frame: Baseline to Week 10, Follow-up at Week 14, End of Study at Week 26
Clinically significant changes in physical examination results - Skin. Patients are ranked as normal or abnormal per body system.
9 secondary outcomes
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at Rest (ANCOVA Model)
Time frame: 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)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Cough (ANCOVA Model)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Body Aches (ANCOVA Model)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain (ANCOVA Model)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes From Baseline in Subject's Energy - Fatigue Assessment Form (ANCOVA Model)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (General Health)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Level of Depression - PHQ 9 Scale.
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Changes in Subject's Quality of Life - Short Form 36 Health Survey Questionnaire (Physical Functional Score)
Time frame: Baseline (Infusion 1) to Weeks 26 (End of Study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh Cheng, MD principal investigator
Hope Biosciences Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB-adMSCs (allogeneic) in people with Post COVID-19 Syndrome, run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Visual Analog Scale of Neurological Symptoms. - Extreme Fatigue (ANCOVA Model) (time frame: Baseline to Weeks 26). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.