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临床试验/EUCTR2020-005952-39-DE
EUCTR2020-005952-39-DE进行中（未招募）1 期

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, FIRST-IN-HUMAN, PHASE IB/II STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND EFFICACY OF COR-101 (SARS COV-2 NEUTRALIZING ANTIBODY) IN HOSPITALIZED PATIENTS WITH MODERATE TO SEVERE COVID-19

CORAT Therapeutics GmbH0 个研究点目标入组 261 人开始时间: 2021年2月3日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
261
研究概览入排标准研究者记录与标识符相似试验

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. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol.
  • •2. The patient is male or female adult =18 years (as per local laws) of age at the time of giving informed consent.
  • •3. The patient is admitted to a hospital (<72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 test by standard Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay or equivalent test.
  • •4. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 prior to study treatment on Day 1:
  • •i. Radiologically or clinically confirmed COVID-19 disease
  • •ii. Clinical signs suggestive of moderate/severe illness with COVID-19, such as:
  • •a. respiratory rate =20 breaths per minute, or
  • •b. SpO2 >93% or = 93% on room air at sea level or,
  • •c. heart rate =90 or = 125 beats per minute for moderate or severe illness, respectively
  • •d. No clinical signs indicative of critical COVID-19
  • •Please note: To standardize the assessment of COVID-19 severity, respiratory rate, SpO2, and heart rate will be measured when the patient is on room air (ie, no supplemental oxygen) and at rest for at least 5 minutes.
  • •5. The patient agrees to not participate in another clinical study of antibody therapy from screening until Day 80, and of any other investigational drug expected to interfere with the study endpoints from screening until Day 28.
  • •6. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of screening until at least 80 days after the last dose of study medication:
  • •a. Vasectomy with documentation of azoospermia.
  • •b. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 80 days after the last dose of study medication)
  • •c. Male condom plus partner use of one of the contraceptive options below: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
  • •7. WOCBP must agree to comply with one of the following contraception requirements from the time of screening until at least 80 days after the last dose of study medication:
  • •a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • •ii. intravaginal
  • •iii. transdermal
  • •b. progestogen-only hormonal contraception associated with inhibition of ovulation :
  • •ii. injectable
  • •iii. implantable
  • •c. intrauterine device (IUD)
  • •d. intrauterine hormone-releasing system ( IUS)
  • •e. bilateral tubal occlusion
  • •f. vasectomised partner with documentation of azoospermia
  • •g. sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 80 days after the last dose of study medication)).
  • •The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (eg, male sterility), the investigator will determine what is consistent and correct use. The investigator is responsible for ensuring that patients underst

排除标准

  • •1. The patient, in the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1.
  • •2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1.
  • •a. Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms.
  • •b. Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness (especially no dyspnea) but no clinical signs indicative of moderate, severe, or critical COVID-19.
  • •c. Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least one of the following: shock defined by systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors; respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen =0.5), non-invasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation), and/or multi-organ dysfunction/failure.
  • •3. The patient has a Child Pugh score >A.
  • •4. The patient has an estimated glomerular filtration rate (eGFR) <30 mL/min//1.73m2 or requires dialysis.
  • •5. The patient has a documented medical history of infection with human immunodeficiency virus or a chronic or active hepatitis B, or C at screening. The patient will be tested at screening if there is no documented history
  • •6. The patient has clinically significant ECG abnormalities at screening.
  • •7. The patient has experienced new onset stroke or seizure disorder during hospitalization and prior to Day 1 of the study.
  • •8. The patient has a history of relevant CNS pathology or current relevant CNS pathology.
  • •9. The patient has congestive heart failure, defined as New York Heart Association Class = III.
  • •10. The patient has acute left ventricular failure or myocardial infarction.
  • •11. Body weight at screening and/or Day 1 >120 kg
  • •12. A female patient who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) or prior to dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests.
  • •13. The patient is planning to donate or bank ova or sperm from Day 1 until 80 days after the last dose of study drug.
  • •14. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study.
  • •15. The patient has a history of sensitivity to any of the study drugs or components thereof or a history of drug or other allergy (including systemic anaphylaxis) that, in the opinion of the investigator or medical monitor, would contraindicate their participation.
  • •16. The patient has participated in and/or plan to participate in another clinical study using an investigational product within the following period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product

研究者

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