COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04472728

Capucine Morelot-Panzini

Not reported

2020-07-15

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: age: 45 and older (in france: 55 and older) 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. 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 with evidence of pneumonia based on all of the following: clinical findings on a physical examination respiratory symptoms developed within the past 14 days 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: tachypnea: ≥25 breaths per minute arterial oxygen saturation ≤92% 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 without a significant deterioration in liver function tests: alt and ast ≤ 5x upper limit of normal (uln) gamma-glutamyl transferase (ggt) ≤ 5x uln total bilirubin ≤ 5×uln willing to participate and able to sign an informed consent form (icf) female subjects 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; or have a negative urine pregnancy test at screening be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. male subjects 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 subject 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. male subjects 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; for france only: being affiliated with a european social security.

not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication) moribund condition (death likely in days) or not expected to survive for >7 days - due to other and non-covid-19 related conditions patient on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ecmo) patient within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (acei), angiotensin receptor blockers (arb) or recombinant ace-2 patient not able to take medications by mouth (as capsules or as a powder, mixed in water). 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) any known hypersensitivity to any of the ingredients, or excipients of the study medication, bio101 in france: non-affiliation to compulsory french social security scheme (beneficiary or right-holder) being under tutelage or legal guardianship

2

Biophytis

45

100

Belgium;Brazil;France;Puerto Rico;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

238

End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.;For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.;For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.

None

Phase 2/Phase 3

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