A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.
Condition: COVID-19
MeSH terms: COVID-19
Intervention: HB-adMSCs; Placebos
Intervention description: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells; Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coronavirus; Prevention; Immune support; stem cells; mesenchymal stem cells; adipose-derived mesenchymal stem cells

Summary:

      Hope Biosciences is conducting a research study of an investigational product called
      allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide
      immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of
      five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men, and women 18 years of age or older

          -  Participant works in a capacity that is characterized as high-risk or very high-risk

          -  High-Risk Exposure jobs are those with high potential for exposure to known or
             suspected sources of COVID-19.

          -  First responders, health care delivery and support staff (e.g., law enforcement, fire
             fighters, paramedics, doctors, nurses, and other hospital staff who must enter
             patients' rooms) exposed to individuals potentially having COVID-19.

          -  Mortuary workers involved in preparing (e.g., for burial or cremation) the bodies of
             people who are known to have, or suspected of having, COVID-19 at the time of their
             death

          -  Very High-Risk Exposure jobs are those with high potential for exposure to known or
             suspected sources of COVID-19 during specific medical, postmortem or laboratory
             procedures.

          -  Health care workers (e.g., doctors, nurses, dentists, paramedics, emergency medical
             technicians) performing aerosol-generating procedures (e.g., intubation, cough
             induction procedures, bronchoscopies, some dental procedures and exams or invasive
             specimen collection) on known or suspected COVID-19 patients.

          -  Health care or laboratory personnel collecting or handling specimens from known or
             suspected COVID-19 patients (e.g., manipulating cultures from known or suspected
             COVID-19 patients).

          -  Morgue workers performing autopsies, which generally involve aerosol-generating
             procedures, on the bodies of people who are known to have, or suspected of having,
             COVID-19 at the time of their death

          -  No signs or symptoms of infection, including but not limited to, body temperature >100
             F and pulse rate > 100 BPM.

          -  Subject provides written informed consent prior to initiation of any study
             procedures.--Agrees to the collection of venous blood per protocol.

          -  Agrees to conformational testing for SARS-CoV-2 before end of study.

        Exclusion Criteria:

          -  Women who are pregnant or lactating, or those who are not pregnant but do not take
             effective contraceptive measures

          -  Patients who are participating in other clinical trials or have intake of
             investigational drug within the previous 30 days;

          -  Inability to provide informed consent or to comply with test requirements;

          -  Any medical disease or condition that, in the opinion of the site PI 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.

          -  Patients who have received a stem cell treatment within one year.

          -  Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time
             prior to or during the study.