Clinical trial NCT04348435: A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess Efficacy and Safety of Allogeneic HB-adMSCs to Provide Immune Support Against COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus
Prevention
Immune support
stem cells
mesenchymal stem cells
adipose-derived mesenchymal stem cells
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Hope Biosciences
First posted: 2020-04-16
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Number of Participants That Were Hospitalized Due to COVID-19 Symptoms
timeFrame: Week 0 through Week 26 (End of Study)
measure: Number of Participants That Had Symptoms Associated With COVID-19
timeFrame: Week 0 through Week 26 (End of Study)
Secondary outcomes:
measure: Leukocyte Differential Count
timeFrame: Week 0 to Week 26 (End of Study)
measure: C Reactive Protein
timeFrame: Week 0 through Week 26 (End of Study)
measure: Tumor Necrosis Factor - Alpha
timeFrame: Week 0 through Week 26 (End of Study)
measure: Interleukin 6
timeFrame: Week 0 through Week 26 (End of Study)
measure: Interleukin 10
timeFrame: Week 0 through Week 26 (End of Study)
measure: Short Form-36 (SF-36)
timeFrame: Week 0 to Week 26 (End of Study)
measure: Patient Health Questionnaire (PHQ-9) Scores
timeFrame: Week 0 to Week 26 (End of Study)
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Hope Biosciences Stem Cell Research Foundation
state: Texas
Study officials:
affiliation: Hope Biosciences Stem Cell Research Foundation
name: Thanh Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: