Confirmed infection with SARS-CoV-2 (COVID-19) MedDRA version: 20.0 Level: HLT Classification code 10047465 Term: Viral infections NEC System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Biophytis S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 • Ascertain the safety and tolerability of BIO101, in order to facilitate recruitment to part 2 • Obtain preliminary indication of activity of BIO101, in preventing respiratory deterioration in the target population Part 2 • Re-assess the sample size that is needed for the confirmatory part of the study • Provide confirmation on the benefit of BIO101 in the target population • Identify and assess potential biomarkers for further understanding of the effect of BIO101 in the target population ;Secondary Objective: Not applicable;Primary end point(s): 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 TNFa 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: • Proportio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary: • Proportion of participants with ‘positive’ events: o official discharge from hospital care by the department due to improvement in participant condition (self-discharge by particpant is not considered a positive event) Additional secondary endpoints: • SpO2/FiO2 • Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2) • Proportion of participants with events of all-cause mortality • Time to 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 • Time to event: official discharge from hospital care due to improvement • The National Early Warning Score 2 (NewS2) • Population-PK study (pop-PK) Secondary Endpoints to Assess Durability of Effect: • For participants who experienced a ‘positive’ event: o Proportion of participants with the occurrence of negative event, within the 14-day post intervention and 28- and 90-day postrandomization time frame. o Time to event: occurrence of a negative event during the 28- and 90 day period. o Proportion of participants with sustained positive outcome, within the 14-day post intervention and 28- and 90-day postrandomization time frame. o Time to event: official discharge from hospital-care due to improvement without re hospitalization or death during the 28- and 90 day period. • For participants who experienced a ‘negative’ event: o Proportion of participants with sustained positive outcome, within the 14-day post intervention and 28- and 90-day postrandomization time frame. o Time to event: resolution of a negative event during the 28- and 90 day period. o Proportion of participants with sustained positive outcome, within the 14-day post intervention and 28- and 90-day postrandomization time frame. o Time to event: official discharge from | — |
Countries
Belgium, Brazil, France, United Kingdom, United States
Contacts
Public ContactMounia Chabane De Saint Aubin
Biophytis S.A.
Outcome results
None listed