Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: HB-adMSC; Placebo
Intervention description: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Healthy volunteers: No
Keywords: Coronavirus; Stem cells; Mesenchymal stem cells; Adipose-derived mesenchymal stem cells; MSCs; COVID; SARS-CoV-2; Coronavirus disease

Summary:

      Hope Biosciences is conducting a research study of an investigational product called
      allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for
      patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy
      of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men, and women, over 18 years of age inclusively.

          2. Patient is suspected to have COVID-19 infection.

          3. Provides consent or consent is given by their legally authorized representative (LAR).

          4. Agrees to the collection of venous blood per protocol.

          5. Women of childbearing potential (WOCBP) and men (if their sexual partners are WOCBP)
             must use at least 1 highly effective form of birth control throughout the study and
             for 6 months after the last dose of study treatment. Highly effective methods of birth
             control include true sexual abstinence (defined as refraining from heterosexual
             intercourse during the entire period of risk, in line with the preferred and usual
             lifestyle of the patient), surgery (bilateral tubal ligation or occlusion,
             vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive
             associated with inhibition of ovulation (oral, patch, injectable, implantable, or
             intravaginal), intrauterine device (IUD), or intrauterine hormone-releasing system
             (IUS).

        Exclusion Criteria:

          1. Pregnancy, lactation and those who are not pregnant but do not take effective
             contraceptive measures, in women of childbearing age. Absence of pregnancy will be
             confirmed through urine pregnancy test.

          2. Patients who have participated or are participating in a clinical trial of an
             experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days.

          3. Inability to provide informed consent or to comply with study requirements.

          4. Patients with the following concomitant or past medical history:

               -  Both Hypertension and Diabetes Mellitus.

               -  Both Hypertension and Chronic Kidney Disease.

               -  Both Diabetes Mellitus and Chronic Kidney Disease.

          5. History or evidence of alcohol abuse.

          6. History or evidence of consumption of illicit drugs.

          7. Patients requiring mechanical ventilation.

          8. Patients who are determined by the Principal Investigator to be unsuitable for study
             enrollment for other reasons.

          9. Any medical disease or condition that, in the opinion of the site Principal
             Investigator or sub-investigator, precludes study participation. Including acute,
             subacute, intermittent or chronic medical disease or condition that would place the
             subject at an unacceptable risk of injury, render the subject unable to meet the
             requirements of the protocol, or may interfere with the evaluation of responses or the
             subject's successful completion of this trial.