Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage)

Biophytis S.A.0 个研究点目标入组 465 人开始时间: 2020年5月3日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 465

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. Age: 45 and older.
•2. Modified per Amendment 10:
•2.1 A confirmed diagnosis of COVID-19 infection, within the last 28 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used.
•3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration >=3 days
•a. Patients can be included even if treated with: oxygen
•supplementation, High-flow oxygen (HFO2), BiPAP and CPAP
•4. Modified per Amendment 10:
•4.1 With evidence of pneumonia based on all of the following:
•a. Clinical findings on a physical examination
•b. Respiratory symptoms developed within the past 14 days
•5. Modified per Amendment 10:
•5.1 With evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
•a. Tachypnea: =25 breaths per minute
•b. Arterial oxygen saturation =92%
•c. A special note should be made if there is suspicion of COVID-19-related myocarditis or pericarditis, as the presence of these is a stratification criterion
•6. Without a significant deterioration in liver function tests:
•a. ALT and AST = 5x upper limit of normal (ULN)
•b. Gamma-glutamyl transferase (GGT) = 5x ULN
•c. Total bilirubin = 5×ULN
•7. Willing to participate and able to sign an informed consent form (ICF).Or, when relevant, a legally authorized representative (LAR) might sign the ICF on behalf of the study participant
•8. Female participants should be:
•at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile;
•a. Have a negative urine pregnancy test at screening
•b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
•9. Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product;
•Note: medically acceptable methods of contraception that may be used by the participant and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy.
•10. Female participant who are lactating must agree not to breastfeed during the study and up to 14 days after the intervention.
•11. Male participants must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product;
•12. Inclusion criterion 12 removed per Amendment 10.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

排除标准

•1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
•2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions
•3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO)
•4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water).
•5. Disallowed concomitant medication:
•a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents)
•6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
•7. Exclusion criterion 7 removed per Amendment 10
•8. Exclusion Criterion 8 removed per Amendment 10

研究者

发起方

Biophytis S.A.

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