Overview

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.

Eligibility

Inclusion Criteria:

        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.
          -  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.
        Exclusion Criteria:
        A study participant will not be eligible for inclusion in this clinical trial if any of the
        following criteria apply:
          1. The subject is unable to provide informed consent or to comply with study
             requirements.
          2. 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.
          3. 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.
          4. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take
             adequate contraceptive measures. *
          5. The study participant has a history of addiction or dependency, or he or she is
             currently abusing or using substances.
          6. Study participant has any active malignancy, including but not limited to evidence of
             cutaneous basal, squamous cell carcinoma, or melanoma.
          7. 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).
          8. 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.
          9. The study participant has received an experimental drug within 12 months before the
             first dose of the investigational product. (Except for COVID-19 vaccinations)
         10. 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.
         11. 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.
         12. The study participant is unlikely to complete the study or adhere to the study
             procedures.
         13. The study participant has a previously diagnosed psychiatric condition that may affect
             self-assessments in the investigator's opinion.
         14. Study participants with any systemic infection requiring treatment with antibiotics,
             antivirals, or antifungals within 30 days before the first dose of the investigational
             product.
         15. 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.
         16. 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.
         17. 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.
         18. Subjects who have fatigue due to chronic kidney disease, iron deficiency anemia, B12
             deficiency and other anemias will be excluded.
         19. Any participant who has suicidal ideation at the screening visit will be excluded from
             this clinical trial.
         20. 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.