CONSENT TO PARTICIPATE

Ram Yogendra M.D. and their collaborators are conducting a study to study the clinical response of maraviroc and pravastatin to treat PASC/Long COVID patients.

Clinical studies include only volunteers who choose to take part. Please take your time to make a decision about whether to volunteer for this study. We have prepared information to  help you decide. Discuss it with your friends and family and health care team. If you have any questions please email nursing@immunotrak.org.

WHY IS THIS STUDY BEING DONE?
This study is called Post-acute sequelae of COVID Study protocol.  The purpose of this study is to study the therapeutic response maraviroc 300mg PO and pravastatin 10mg PO daily used to treat long COVID patients using subjective metrics and before and after cytokine panels.

WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
Your data from the IncellKINE report and subjective responses will be collected and analyzed by Ram Yogendra M.D. and the research team. They plan on submitting this data for a publication and for discussions with the U.S. F.D.A.

CAN I STOP BEING IN THE STUDY?
Yes. Your participation in the study is entirely voluntary. You may withdraw from the study, at any time. Your medical care will not be affected by your decision to be in the study or to withdraw from the study. If you are thinking about stopping or decide to stop, please contact the study coordinator at the email listed at the end of this form.  When contacting the study coordinator, please specify in writing if you would like your data withdrawn from future research use. Your data will not be used for future research, however, any de-identified data that has already been distributed to study researchers cannot be retracted.

WHAT RISKS CAN I EXPECT FROM BEING IN THE STUDY?
None
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
By participating in this study, you will help our efforts to answer some important questions about how some of the medications are helping long COVID patients.

WILL MY MEDICAL INFORMATION BE KEPT PRIVATE?
Yes. Your personal medical information in your medical record is kept private. When information from this study is published or presented at scientific   meetings, your name and other personal information will not be used.
WILL I BE PAID FOR TAKING PART IN THIS STUDY?
No.
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
You are free to choose whether or not to participate in this study without penalty. We will inform you of any new information or changes to the study that may affect your health or willingness to continue in the study.

WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
Questions for the study team: nursing@immunotrak.org or 1-650-777-7630 (24 hours)

 

This research is being overseen by CCTC IRB.  An IRB is a group of people who perform independent review of research studies. 

 

 

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.

This research is being overseen by IRB.  An IRB is a group of people who perform independent review of research studies.  You may talk to them at:  nursing@immunotrak.org

You have questions, concerns or complaints that are not being answered by the research team

You are not getting answers from the research team

You cannot reach the research team

You want to talk to someone else about the research

You have questions about your rights as a research subject

If you wish to participate in this study, please enter your signature below.

For Sites in California

AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES

 

What information may be used and given to others?

The study doctor will get your personal and medical information.  For example:

1.    Past and present medical records

2.   Research records

3.   Records about phone calls made as part of this research

4.   Records about your study visits

 

Who may use and give out information about you?

The study doctor and the study stuff.

 

Who might get this information?

The sponsor of this research.  “Sponsor” means any persons or companies that are:

1.    Working for or with the sponsor, or

2.   Owned by the sponsor

 

Your information may be given to:

1.    The U.S. Food and Drug Administration (FDA)

2.   Department of Health and Human Services (DHHS) agencies

3.   Governmental agencies in other countries

4.   The institution where the research is being done

5.   Governmental agencies to whome certain diseases (reportable diseases) must be reported and

6.   Institutional Review Board (IRB)

 

Why will this information be used and/or given to others?

1.    To do the research

2.   To study the results, and

3.   To make sure that the research was done right

 

If the results of this study are made public, information that identifies you will not be used.

 

What if I decide not to give permission to use and give out my health information?

Then you will not be able to be in this research study.

 

You may withdraw or take away your permission to use and disclose your health information at any time.  You do this by sending written notice to the study doctor.  If you withdraw your permission, you will not be able to stay in this study.

 

When you withdraw your permission, no new health information identifying you will be gathered after that date.  Information that has already been gathered may still be used and given to others.

 

Is my health information protected after it has been given to others?

There is a risk that your information will be given to others without your permission.

 

Authorization:

I have been given the information about the use and disclosure of my health information for this research study.  My questions have been answered.

 

I authorize the use and disclosure of my health information to the parties listed in the authorization section of this consent for the purposes described above.