EUCTR2020-004206-59-DE进行中（未招募）1 期
RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 - Safety and Efficacy of ATR-002 for Hospitalized Patients with COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2. Study participant must be at least 18 years of age at the time of signing the ICF.
- •3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). 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.
- •4. Body weight at least 50 kg and have a body mass index (BMI) = 18.0 kg/m2 and < 40.0 kg/m2.
- •5. Male or female.
- •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 of the protocol.
- •b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at 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 of the protocol.
- •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 1.1.1 of the protocol.
- •c. The partner is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 90 days 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.
- •d. He acknowledges that sperm donation is prohibited from the first dose of IMP until at least 90 days after the last dose of IMP.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patient’s clinical condition is worsening rapidly.
- •2. Requiring ICU admission or ventilator support at screening or at randomization.
- •3. 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. History of hypertension should have hypertension adequately controlled (BP < 140/90 mmHg) with appropriate anti-hypertensive treatment.
- •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. History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting 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) < 45 ml/min/1.73m2.
- •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 (=1.5 x ULN total bilirubin if known Gilbert’s syndrome).
- •22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as prohibited” in Section 10.5 of the protocol.
- •23. Taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for COVID-19. 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.
- •24. Taking medication that may seriously affect the immune system, e.g. chemotherapy, unless considered and documented as standard of care (e.g. corticosteroids) to treat COVID-19.
- •25. Currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization.
- •26. Known allergy or hypersensitivity to the IMP (including e
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