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Column | Value |
---|---|
Trial registration number | EUCTR2020-001498-63-BE |
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001498-63/BE |
First author
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
|
Contact
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
mounia.chabane@biophytis.com |
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2020-05-03 |
Recruitment status
Last imported at : May 19, 2022, 7:30 p.m. Source : EU Clinical Trials Register |
Completed |
Study design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Randomized |
Design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Adaptive |
Masking
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Blind label |
Center
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
multi-center |
Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Treatment |
Inclusion criteria
Last imported at : Feb. 12, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
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, OR 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. |
Exclusion criteria
Last imported at : Feb. 12, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
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 |
Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2 |
Funding
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Biophytis S.A. |
Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
None |
Countries
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Belgium;Brazil;France;United Kingdom;United States |
Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Moderate/severe disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
4: Moderate/severe disease at enrollment |
Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
65 |
primary outcome
Last imported at : Feb. 12, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
For end-of-part-1 interim analysis: For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days: Safety and tolerability to BIO101: • SUSARs, SAEs, AESIs, AEs • Vital signs • Safety labs (including testicular biomarkers) • ECGs For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days: Primary: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO Secondary: • SpO2/FiO2 • Inflammatory markers including: o IL 6 o TNFα o D-dimer • RAS / MAS biomarkers: o Angiotensin 2 o Angiotensin 1-7 (Ang (1-7) o Angiotensin 1-5 (Ang 1-5) o Angiotensin 1 o Angiotensin-converting enzyme 2(ACE2) levels and activity For part-2 sample size interim analysis: For sample size re-assessment for part 2, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO For the final analysis: Primary, time frame – up to 28 days: • Proportion of participants with ‘negative’ events, of either of the following: o All-cause mortality o Respiratory failure, defined as any of the following: - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) - Requiring ECMO |
Notes
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Declared number of arm (3.0) differs from found arms (2.0) |
Phase
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Phase 2 |
Arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "", "treatment_id": 201, "treatment_name": "Bi0101", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |