Study of the Safety and Effectiveness of Experimental AT-527 for Moderate COVID-19 (Coronavirus) Infection

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years and older
Gender:
Any
Healthy Volunteers: No
Keywords: COVID-19, coronavirus
Type: Drug Study
Target:
10 Participants
Investigator:
Description
This study will be conducted in people who are hospitalized or confined in a hospital-associated health facility for COVID-19.

The main purposes of the study is to learn about the following:

· the side effects and tolerability of experimental AT-527 in people with COVID-19 (safety)

· whether the experimental study drug, AT-527, is an effective treatment for COVID-19 (efficacy)
This study requires

If you are one of the first 20 subjects enrolled in the study:

  • You take 1 tablet (550 mg AT-527 or placebo) approximately every 12 hours (or twice a day) for a total of 10 days.

Otherwise, if you are enrolled after the first 20 subjects:

  • Your first dose will be 2 tablets (1100 mg of AT-527 or placebo).

  • You will then take 1 tablet (550 mg AT-527 or placebo) approximately every 12 hours for an additional 19 doses.

  • Your total treatment will be 10 days in total.

You will take the tablet(s) by mouth (orally) with water. You will take them at approximately the same time each day.

Your study doctor or study staff will provide you with additional information on study drug dosing.

Who can participate

Inclusion Criteria:

  1. Willing and able to provide informed consent.
  2. Male or female subjects between 45 and 80 years of age.
  3. Hospitalized or in a hospital-affiliated confinement facility for which the principal investigator is credentialed and study staff have access to study participants and their data.
  4. Subject must be diagnosed with COVID-19 (SARS-CoV-2 positive) by a standard assay or equivalent testing. Note: SARS-CoV-2 infection will be confirmed with an FDA EUA-approved assay.
  5. Moderate disease defined by the following:  Symptoms of lower respiratory infection with COVID-19, with initial symptom onset within 4 days prior to Screening:  At least 1 of the following: fever (> 38.3 °C), cough, sore throat, fatigue/malaise, headache, muscle pain, or more significant lower respiratory symptoms including dyspnea (at rest or with exertion)  Clinical signs indicative of lower respiratory infection with COVID-19 (as above), with:  SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula in order maintain SpO2 ≥ 93%
  6. Subjects must also have at least one of the following known risk factors for poor outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
  7. QTcF interval ≤ 450 ms for males and ≤ 460 ms for females at Screening.
  8. Males and females of childbearing potential must agree to use protocol specified methods of contraception as described in Section 5.9.
  9. Females who are not post-menopausal must have negative pregnancy tests at Screening and pre-treatment on Day 1.
  10. Male subjects must agree not to donate sperm from the first dose through 90 days after the last dose of study drug.
  11. Subject must be able to take oral tablet medications.
  12. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.

Exclusion Criteria:

  1. Female subject is pregnant or breastfeeding.
  2. Clinical signs indicative of severe or critical COVID-19 illness, defined as any of the following: RR ≥30, HR ≥125, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula to maintain SpO2 ≥93%, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
  3. Any subject with a concomitant life-threatening condition, including but not limited to the following: requiring mechanical ventilation, acute respiratory distress syndrome (ARDS), shock, cardiac failure or suspected bacterial sepsis.
  4. Evidence of lobar or segmental consolidation on chest imaging.
  5. Congestive heart failure or myocardial infarction within the previous 6 months.
  6. Recurrent nausea, vomiting or known malabsorption syndrome.
  7. Creatinine clearance < 60 mL/min
  8. Abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator.
  9. Treatment with other drugs thought to possibly have activity against SARSCoV-2. Note: If the subject was previously treated with such an agent, treatment must have been discontinued at least 7 days prior to planned dosing on the current trial.
  10. Use of other investigational drugs within 30 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study.
  11. S-T segment elevation or other clinically significant abnormal ECG at Screening, as determined by the investigator.
  12. Subject has history of active hepatitis B infection or uncured hepatitis C infection. Subjects with human immunodeficiency virus (HIV) infection are allowed, as long as they are virologically suppressed with CD4 count at least 500 cells/mm3.
  13. Active clinically significant diseases including:  Active urinary tract infection  Hospitalized for asthma within the past 12 months  History of severe renal impairment or receiving renal replacement therapy (hemodialysis, peritoneal dialysis)
  14. Subjects with malignant disease can continue antineoplastic therapy during the study period unless the antineoplastic therapy includes an immunomodulator.
  15. Requires frequent or prolonged use of systemic corticosteroids or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions).
  16. Abnormal values at Screening:  ALT or AST > 5 x upper limit of normal (ULN)  Total bilirubin > 1.5 x ULN, unless the subject has known Gilbert’s syndrome  Hemoglobin < 10 g/dL for females or < 12 g/dL for males  Total white blood cell (WBC) count < 3,500/mm3 or absolute neutrophil count < 1,500/mm3  Platelet count < 80 x 109/L
  17. Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the subject or impact subject compliance or safety/efficacy observations in the study.
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
You will be paid up to $300, $20 for completing the screening visit, days 1-14 and your end of treatment visit. Payment will be provided at the end of the study visit in the form of a check. If you choose to leave or we take you off the study before you complete the study visit, you will receive only payment for visits you have completed. If you complete all the study visits, you will receive $300 for being in this study.
Resources
Schedule
Study duration and period
The main part of the study will last for approximately two weeks (14 days) from the start of study drug dosing. You will be followed for an additional 2 weeks after you are discharged (released) from the hospital/facility. If you are still hospitalized/confined after Day 14, you will be followed for up to an additional 4 weeks while you are in the hospital/facility. You will take the study drug (AT-527 tablets or placebo tablets) by mouth for 10 days. The placebo tablet looks the same as the AT-527 tablets but contains no AT-527.
Recruitment period
From June 9, 2020
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • COVID-19
  • coronavirus

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


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview