Safety and effectiveness of AT-527 compared to placebo, in moderate Covid-19 disease
- Conditions
- COVID-19MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-002869-34-BE
- Lead Sponsor
- Atea Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 190
1. Willing and able to provide informed consent.
2. Male or female subjects =18 years of age.
3. Subject is 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 5 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 or mask to 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.
9. Females of childbearing potential must have a negative pregnancy test at Screening.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
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 or mask 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 or extracorporeal membrane oxygenation (ECMO) 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, that would interfere with oral medication treatment.
7. Creatinine clearance < 60 mL/min (Cockcroft-Gault formula)
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 SARS-CoV-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. The use of hydroxychloroquine is not allowed in this trial. Convalescent plasma is permitted as part of local SOC.
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 a 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
- 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 or is expected to result in severe bone marrow suppression during the study (e.g., risk for grade 3 or higher anemia, leukopenia, or thrombocytopenia).
15. Requires use of immunosuppressive doses of systemic corticosteroids, defined as the equivalent of 20 mg prednisone daily during any two week time period (280 mg prednisone equivalent total dose) in the three months prior to study entry. Low-level dexamethasone dosing (6 mg/day) is allowed, according to investigator preference.
16. Requires use of immunosupresive drugs (e.g. for organ transplantation or autoimmune conditions) during the primary 14-day study period.
17. Concomitant use of any known major inhibitor or inducer of P-glycoprotein (P-gp), as described in Section 5.8. Investigational product dosing cannot be initiated unless the investigator feels that the concomitant medication can be safely discontinued or substituted.
18. Concomitant use or prior use of hydroxychloroquine or amiodarone within 7 days of Screening.
19. 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 sy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method