A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.

Hope Biosciences Research Foundation

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Other: Placebos; Biological: HB-adMSCs

Study type: Interventional

Funder types: Industry

Identifiers

NCT04348435

HBCOV02

Details and patient eligibility

About

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.

Full description

This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 100 patients will be enrolled. Eligible participants are at high or very high exposure risk of contracting COVID-19. The primary endpoint of this study is to provide immune support against COVID-19, measured by the percentage of subjects that develop symptoms of COVID-19. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.

Enrollment: 53 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 4 patient groups, including a placebo group

Allogeneic HB-adMSCs 200MM

Experimental group

Description:

Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.

Treatment:

Biological: HB-adMSCs

Allogeneic HB-adMSCs 100MM

Experimental group

Description:

Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.

Treatment:

Biological: HB-adMSCs

Allogeneic HB-adMSCs 50MM

Experimental group

Description:

Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. Infusions will occur at weeks 0, 2, 6, 10, and 14.

Treatment:

Biological: HB-adMSCs

Placebo

Placebo Comparator group

Description:

Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Infusions will occur at weeks 0, 2, 6, 10, and 14.

Treatment:

Other: Placebos