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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)

Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 22 May 2020

At a glance

  • Drugs Sarconeos (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms COVA
  • Sponsors Biophytis
  • Most Recent Events

    • 22 May 2020 Status changed from planning to recruiting.
    • 20 May 2020 According to a Biophytis media release, the company expects to start this trial in the coming weeks in Belgium and plans to expand the trial at multiple sites in Europe and US pending potential approvals from the ANSM, MHRA and FDA.
    • 20 May 2020 According to a Biophytis media release, an interim analysis conducted by an independent Data Monitoring Committee (DMC) is expected in the 4th quarter of this year, subject to the evolution of the COVID-19 epidemic, will determine whether the study should progress into the second part and will allow recruitment of required sample size needed for detecting Sarconeos (BIO101) effects in part 2.

Trial Overview

Purpose

Part 1- 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

Primary Endpoints

For end-of-part-1 interim analysis:
For obtaining indication of activity of BIO101 and decision to begin part 2 and on study extension, time frame – up to 14 days:
• Number of 'negative' events, of either of the following:
o Respiratory failure, defined as either of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring high-flow oxygen
o All-cause mortality
For part-2 sample size interim analysis:
For sample size re-assessment for part 2 – time frame up to 28 days:
• Number of 'negative' events, of either of the following:
o Respiratory failure, defined as either of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring high-flow oxygen
o All-cause mortality
For the final analysis:
Primary, time frame – up to 28 days:
• Number of 'negative' events, of either of the following:
o Respiratory failure, defined as either of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring high-flow oxygen
o All-cause mortality
Timepoint: For end-of-part-1 interim analysis: For obtaining indication of activity of BIO101 and decision to begin part 2 and on study extension, time frame – up to 14 days For part-2 sample size interim analysis: For sample size re-assessment for part 2 – time frame - up to 28 days: For the final analysis: Primary, time frame – up to 28 days:

Other Endpoints

Key secondary:
• Number of 'positive' events:
o Official discharge from hospital care by the department due to improvement in patient condition (self-discharge by patient is not considered a positive event)
• Number of events, of respiratory failure, defined as either of the following:
o Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
o Requiring high-flow oxygen
• Safety and tolerability to BIO101
Additional secondary end-points:
• Time to events, of either of the following:
o Respiratory failure, defined as either of the following:
- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
- Requiring high-flow oxygen o All-cause mortality
• Time to event: official discharge from hospital care due to improvement
• The National Early Warning Score 2 (NewS2)
• Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2)
•Number of CPAP/BiPAP events, defined as requiring CPAP/BiPAP in participants entering the study on low flow oxygen)
• Population-PK study (pop-PK)
Timepoint: During the trial [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 545

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

1. Age: 18 and older. The population will be randomized in 2 strata: up toand including 60 years old and above 60 years old.2. A confirmed diagnosis of COVID-19 infection, within the last 14 days, prior to randomization, as determined by PCR or other approved commercial or public health assay in any 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 days4. With evidence of pneumonia based on all of the following:a. Clinical findings on a physical examinationb. Respiratory symptoms developed within the past 7 days5. With evidence of respiratory decompensation not more than 4 days before start of study medication, meeting one of the following criteria, as assessed by healthcare staff:a. Tachypnea: ≥25 breaths per minuteb. Arterial oxygen saturation ≤92%, on Oxygen at least 3L/minc. A special note should be made if there are evidence for COVID-19 related myocarditis or pericarditis, as the presence of these is a stratification criterion6. Without a significant deterioration in liver function tests:a. ALT and AST ≤ 5x upper limit of normal (ULN)b. Gamma-glutamyl transferase (GGT) ≤ 5x ULNc. Total bilirubin ≤ 5×ULN7. Willing to participate and able to sign an informed consent form (ICF)8. Willing to use double-contraceptive methods, if sexually active, during the study and until 14 days after last dose of study medication.9. For France only: Being affiliated with a European Social Security.

Patient 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 conditions3. Patient on invasive mechanical ventilation via an endotracheal tube, or ECMO, or high flow Oxygen4. Patient within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or recombinant ACE-25. Patient not able to take medications by mouth (as capsules or as a powder, mixed in water).6. Concomitant medication allowed and not allowed:a. For the whole studyi. Currently receiving any ACEi, ARBs treatment, or renin or aldosterone inhibitors within 7 days before screeningii. 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)b. For part 1:i. Other treatments to COVID-19, including antimalarial or antimicrobial agents are allowed before or during the study.7. Women during a known pregnancy or a positive pregnancy test in urinea. Mothers who are breastfeeding, will not be able to do so during and for 14 days after participation in the study8. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO1019. Renal disease requiring dialysis, or known renal insufficiency (eGFR≤ 30 mL/min/1.73 m2, based on Cockroft & Gault formula)

Trial Details

Identifiers

Identifier Owner
EudraCT2020-001498-63 European Clinical Trials Database
BIO101CL05 -

Organisations

  • Sponsors Biophytis
  • Affiliations Biophytis

Trial Dates

  • Initiation Dates

    Actual : 18 May 2020

  • End Dates

    Planned : 18 Nov 2020

Other Details

  • Design double-blind; multicentre; prospective; randomised; sequential
  • Phase of Trial Phase II/III
  • Location Belgium; Europe; France; United Kingdom; USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
SarconeosPrimary Drug Oral Capsule

Product Name: BIO101
Investigational Medicinal Product Code: BIO101
Pharmaceutical Form: Capsule
IMP Routes of Administration: Oral use
Active Substance CAS number: 5289-74-7
Active Substance Current Sponsor Code: BIO101
Active Substance other descriptive name: 20-hydroxyecdysone
EV Substance code: SUB193629
Active Substance Concentration unit: mg milligram(s)
Active Substance Concentration type: equal
Active Substance Concentration: 175
Chemical Origin Active Substance: yes

Number Of treatment arms In the trial: 2

Is placebo used in this trial?: yes

Trial Centres

Centres

Centre Name Location Trial Centre Country
Biophytis S.A.
+33(0)144 27 23 87
B.5.6 E-mail mounia.chabane@biophytis.com
show details
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Trial History

Event Date Event Type Comment
22 May 2020 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2020-001498-63). Updated 22 May 2020
22 May 2020 Status change - recruiting Status changed from planning to recruiting. Updated 22 May 2020
20 May 2020 Other trial event According to a Biophytis media release, the company expects to start this trial in the coming weeks in Belgium and plans to expand the trial at multiple sites in Europe and US pending potential approvals from the ANSM, MHRA and FDA. Updated 22 May 2020
20 May 2020 Other trial event According to a Biophytis media release, an interim analysis conducted by an independent Data Monitoring Committee (DMC) is expected in the 4th quarter of this year, subject to the evolution of the COVID-19 epidemic, will determine whether the study should progress into the second part and will allow recruitment of required sample size needed for detecting Sarconeos (BIO101) effects in part 2. Updated 22 May 2020
20 May 2020 Other trial event According to a Biophytis media release, Dr Muriel Lins (Pulmonologist at AZ Sint Maarten hospital in Mechelen) is the Principal Investigator of COVA in Belgium. Updated 22 May 2020
20 May 2020 Other trial event According to a Biophytis media release, the company has received approval from the Belgian regulatory agency, the Federal Agency for Medicines and Health Products (FAMHP), to proceed with this trial. Updated 22 May 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020
07 Apr 2020 Other trial event According to a Biophytis media release, it has secured a new line of financing that could reach 24 million euros, raised from Atlas, a specialized investment fund based in New York (United States) which will enable it to continue the clinical development of this trial Updated 15 Apr 2020
07 Apr 2020 Other trial event According to a Biophytis media release, the first randomized patient is expected to be recruited at the Pitie-Saletriere Hospital, which is linked with Sorbonne University's medical school, a long-standing partner of Biophytis. Updated 08 Apr 2020
07 Apr 2020 Other trial event According to a Biophytis media release, the company plan to start this trial in the coming weeks following approval from the French National Agency for the Safety of Medicines and should then extend to Belgium and the United States. Updated 08 Apr 2020
07 Apr 2020 Other trial event According to a Biophytis media release, the company has filed a clinical trial application with the French Regulatory Authority (ANSM). Updated 08 Apr 2020

References

  1. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  2. Biophytis. Biophytis Launches COVA Clinical Study with Sarconeos (BIO101) in Covid-19. Media-Rel 2020;.

    Media Release
  3. Biophytis. Biophytis has signed a New Convertible Bond Financing of EUR24 million from Atlas to Continue the Development of Sarconeos (BIO101). Media-Rel 2020;.

    Media Release
  4. Biophytis. Biophytis Receives Approval from the Belgian Regulatory Agency (FAMHP) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
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