Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ATR-002: 900 mg (6 tablets) once daily on Day 1
600 mg (4 tablets) once daily on Days 2 to 6
Intervention2: Placebo: 6 matching placebo tablets
on Day 1
4 matching placebo tablets
on Da
Sponsors
Atriva Therapeutics GmbH
Eligibility
Inclusion criteria
Inclusion criteria: Informed Consent 1. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Age 2. Study participant must be at least 18 years of age at the time of signing the ICF. Type of Participant and Disease Characteristics 3.1 Study participants in India with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate COVID-19 requiring hospitalization for COVID-19 and for medical reasons (see Section 8 and CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India, Version 5, 03.07.20). 3.2 At least one of the following clinical features need to be present: Dyspnea Hypoxia Fever Cough AND 3.3 SpO2 between 90% and 93% on room air AND 3.4 Respiratory Rate more or equal to 24 and less than 30 breaths per minute Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection. Weight 4. Body weight at least 50 kg and have a body mass index (BMI) â?¥ 18.0 kg/m2 and 5. Male or female. Pregnancy and Contraception Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a. She is not a WOCBP as defined in Section 10.3.1. b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of least 4 weeks after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP. 7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of IMP, see Section 8.3.5. a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive. c. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. A male study participant is eligible to participate if: a. He is azoospermic b. The partner is not a WOCBP as defined in Section 10.3.1. c. The partner is a WOCBP and is using a contraceptive method that is highly effective, wit
Exclusion criteria
Exclusion criteria: 1. Patientâ??s clinical condition is worsening rapidly. 2. Requiring ICU admission or ventilator support at screening or at randomization. Suspected bacterial, fungal, viral, or other infection (besides COVID-19). 4. History of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. The medical monitor should be contacted by the investigator. 5.1 Patients with uncontrolled hypertension (BP â?¥ 140/90 mmHg). 6. Clinically significant cardiac conduction abnormalities, including QTc prolongation of > 450 milliseconds. 7. Family history of Long QT Syndrome. 8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA). 9.1 History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, stenting, or thromboembolic event within 24 weeks prior to screening. 10. Patients with implanted defibrillators or permanent pacemakers. 11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %. 12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis. 13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (eGFR, CKD-EPI) 14. Chronic Obstructive Pulmonary Disease (COPD) GOLD C, or D, or hospitalization for exacerbation of COPD within 24 weeks prior to screening. 15. Other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. Asthma with a symptom control level of uncontrolled, according to current GINA guidelines. 17. Currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. Known Hepatitis B or C infection. 19. Any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. Alanine transaminase (ALT) or aspartate transaminase (AST) >3.0 x ULN. 21. Total bilirubin >1.0 x ULN (â?¥1.5 x ULN total bilirubin if known Gilbertâ??s syndrome). Prior/Concomitant Therapy 22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as â??prohibited ? in Section 10.5. 23. Taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for COVID19. Any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and medical monitor. Taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical severity status on a 7 point ordinal scale at Day 15 Time from randomization to discharge from hospital Time to discharge from hospital or to score of â?¤2 maintained for 24 hours in NEWS2 whichever occurs first Time to resolution of fever defined as â?¤36.6°C (axilla) â?¤37.2°C (oral) or â?¤37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours. Time to SpO2 94% on room air maintained for 24 hours Timepoint: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical severity status on a 7 point ordinal scale at Day 15 Time from randomization to discharge from hospital Time to discharge from hospital or to score of â?¤2 maintained for 24 hours in NEWS2 whichever occurs first Time to resolution of fever defined as â?¤36.6°C (axilla) â?¤37.2°C (oral) or â?¤37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours. Time to SpO2 94% on room air maintained for 24 hours Timepoint: Day 3, 5, 8, 11, 15, 30 | — |
Countries
Germany, India, Netherlands, South Africa, Spain
Contacts
Public ContactDr Deepa Arora
Clinexel Life Sciences Private Limited
Outcome results
None listed