Experimental Treatment with Remdesivir for Patients Hospitalized With Coronavirus Infection (COVID-19)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 to 99 years old
Gender:
Any
Healthy Volunteers: No
Keywords: COVID-19, coronavirus, coronavirus infection, novel coronavirus
Type: Other study, Phase 2
Target:
20 Participants
Investigator:
Description
There are no approved medications to treat COVID-19 because it is a new disease caused by a virus that was just identified in 2019 in China. Some people who become sick with COVID-19 have serious disease and must be hospitalized.

This study will test a drug in adult patients that are hospitalized with COVID-19. The drug has been tested before in humans with other diseases. In this study, we would like to make sure that it is safe for use in humans with COVID-19 and see if it can improve patients’ health when they are sick with COVID-19.

We are studying the experimental use of a drug called remdesivir. This drug has been studied in animals and in people. It is given as an infusion, which means that it is given through a plastic tube attached to a needle that is put into a vein in the arm.

To find out if remdesivir (the study drug) works, we need to compare it to getting something that does not have the drug in it, something called a placebo. The placebo looks like the study drug but does not have the drug in it. Using a placebo is common in research studies. The placebo is also given as an infusion. Some people in the study will get the placebo.
This study requires

If you qualify for the study and decide to join, you will get 1 infusion every day while you are a patient in the hospital. The maximum number of infusions you will receive is 10. The infusion will be either study drug or placebo, depending on what group you are in. The infusion takes about 1 hour and will be done in the hospital. We will watch you closely for side effects during the infusion and for 1 hour after the infusion. After you are discharged from the hospital, you will not received any more infusions.

We will take one blood sample and one oropharyngeal (OP) throat swab sample from you on Days 1, 3, 5, 8, and 11 as long as you remain a patient in the hospital. You will come back to the site for study visits on Days 15 and 29. During these follow-up visits, we will ask how you are feeling and if you have been sick. We will take one blood sample and one OP swab sample at Day 15 and 29.

We will use the blood and OP swab samples for research and safety tests. OP swab samples will be tested for presence of the virus that causes COVID-19.

We will obtain some information about you from your inpatient hospital records, such as whether you are receiving oxygen or need additional help breathing and what types of other medicines you are being given as part of your clinical care. This information will help us determine how sick you are and whether you are improving.

As part of this study, we will get extra blood samples from you. We will use your coded information, leftover samples, and extra blood samples for secondary research. Secondary research is research that is not part of this study, and the research is not planned yet. This extra research will occur in the future and it will help us to understand how the study drug works and to develop new treatments and lab tests. This secondary research will not include genetic testing. When you give consent, you will be taking part in the treatment study and allowing for your samples to be used for secondary research.

Who can participate

Inclusion criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
  4. Male or non-pregnant female adult >/=18 years of age at time of enrollment.
  5. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
  6. Illness of any duration, and at least one of the following:
  7. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
  8. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
  9. Requiring mechanical ventilation and/or supplemental oxygen.
  10. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

Exclusion criteria:

  1. Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal.
  2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30)
  3. Pregnancy or breast feeding.
  4. Anticipated transfer to another hospital which is not a study site within 72 hours.
  5. Allergy to any study medication.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
As part of this study, you may receive $20 per completed visit to compensate you for some costs associated with your study visits. If you are unable to finish the study, you will only receive payment for the parts of the study you completed.
Resources
Schedule
Study duration and period
Your total amount of time on this study will be about 29 days.
Recruitment period
From March 6, 2020
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Corona Virus Infection

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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