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Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

Trial Profile

Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 12 May 2021

At a glance

  • Drugs Sarconeos (Primary)
  • Indications COVID-19 pneumonia; Respiratory insufficiency
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms COVA
  • Sponsors Biophytis
  • Most Recent Events

    • 12 May 2021 According to a Biophytis media release, final study results are expected in Q3 2021, subject to any COVID-19-related delays and the impact of the pandemic
    • 12 May 2021 According to a Biophytis media release, recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants, with the aim of filing for Emergency Use Authorization with the US Food and Drug Administration (FDA) and Conditional Approval with the European Medicines Agency (EMA) in Q3 2021.
    • 12 May 2021 According to a Biophytis media release, the company announces that it has recruited the 155th participant for Part 2 of this study. This allows the independent Data Monitoring Committee (DMC) to conduct its second interim analysis, based on safety and efficacy data, for the continuation of the trial in case of favorable results. The Company is to report the recommendations of the DMC based on its review of the second interim analysis results by the end of Q2 2021.

Trial Overview

Purpose

This is a global, multicenter, double-blind, placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19.
Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, tolerability and activity of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19.
Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function from 310 COVID-19 patients (including the 50 patients from Part 1 of the study).

Comments

According to a Biophytis media release, recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants, with the aim of filing for Emergency Use Authorization with the US Food and Drug Administration (FDA) and Conditional Approval with the European Medicines Agency (EMA) in Q3 2021.

Primary Endpoints

End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.

description: For interim analysis intended to obtain indication of activity of BIO101.
Primary endpoint:
• Proportion of subjects with negative events, of either of the following:
All-cause mortality
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 Requiring high-flow oxygen
time_frame: up to 28 days

For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.

description: 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:
All-cause mortality
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 high-flow oxygen
time_frame: up to 28 days

For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.

description: • Proportion of participants with of subjects with negative events, of either of the following.
All-cause mortality
Respiratory failure, defined as any of the following:
Mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
time_frame: up to 28 days

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:

Other Endpoints

Interim analysis; indication of activity of BIO101: Oxygen saturation by pulse oximetry (SpO2) SpO2 / Fraction of inspired oxygen (FiO2) ratio

description: • SpO2/FiO2 time_frame: 28 days

Interim analysis; indication of activity of BIO101: Inflammatory markers

description: • Inflammatory markers including: IL 6 TNFα D-dimer time_frame: 28 days

Interim analysis; indication of activity of BIO101: Renin Angiotensin System biomarkers

description: • Renin Angiotensin System biomarkers: Angiotensin 2 Angiotensin-converting enzyme (ACE) levels time_frame: 28 days

Key secondary endpoint for final analysis: Proportion of participants with positive events

description: • official discharge from hospital care by the department due to improvement in participant condition (self-discharge by participant is not considered a positive event) time_frame: Up to 28 days

Additional secondary endpoints for final analysis: Respiratory function

description: Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2) SpO2/FiO2 Proportion of participants with CPAP/BiPAP events, defined as requiring CPAP/BiPAP/HFO2 in participants entering the study on low flow oxygen) time_frame: 28 days

Additional secondary endpoints for final analysis:proportion of patients who experienced negative events

description: Time to events, of either of the following: All-cause mortality 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; • Proportion of participants with CPAP/BiPAP/HFO2 events, defined as requiring CPAP/BiPAP/HFO2 in participants entering the study on low flow oxygen) time_frame: 28 days

Additional secondary endpoint for final analysis: The National Early Warning Score 2 (NewS2)

description: National Early Warning Score 2 (NewS2): scores: 0-7 time_frame: 28 days

Additional secondary endpoint for final analysis: Population Pharmacokinetics study (pop-PK)

description: Cmax: Peak Plasma concentration time_frame: 1day

Additional secondary endpoint : Population Pharmacokinetics study (pop-PK)

description: tmax: Time to reach peak plasma concentration time_frame: 1 day

Additional secondary endpoint: Population Pharmacokinetics study (pop-PK)

description: AUC: Area under the plasma concentration versus time curve time_frame: 1 day

Additional secondary endpoint: Proportion of participants with events of all-cause mortality

description: Proportion of participants with events of all-cause mortality time_frame: Up to 28 days

Additional secondary endpoint: time to event: negative events

description: Time to events, of either of the following: All-cause mortality 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_frame: Up to 28 days

Additional secondary endpoint: time to event: positive events

description: Time to event: official discharge from hospital care due to improvement time_frame: Up to 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 pneumonia treatment severe
Respiratory insufficiency prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 465

  • Sex male & female
  • Age Group ≥ 45 years; adult; elderly

Patient Inclusion Criteria

1. Age: 45 and older (in France: 55 and older) 2. 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. With evidence of pneumonia based on all of the following: 1. Clinical findings on a physical examination 2. Respiratory symptoms developed within the past 14 days 5. 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: 1. Tachypnea: ≥25 breaths per minute 2. Arterial oxygen saturation ≤92% 3. 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: 1. ALT and AST ≤ 5x upper limit of normal (ULN) 2. Gamma-glutamyl transferase (GGT) ≤ 5x ULN 3. Total bilirubin ≤ 5×ULN 7. Willing to participate and able to sign an informed consent form (ICF) 8. 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 1. Have a negative urine pregnancy test at screening 2. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose. 9. 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. 10. 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; 11. 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 conditions 3. Patient on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO) 4. 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 5. Patient not able to take medications by mouth (as capsules or as a powder, mixed in water). 6. 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) 7. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101 8. In France: - Non-affiliation to compulsory French social security scheme (beneficiary or right-holder) - Being under tutelage or legal guardianship

Trial Details

Identifiers

Identifier Owner
NCT04472728 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001498-63 European Clinical Trials Database
BIO101CL05 -
BIO101 -

Organisations

  • Sponsors Biophytis
  • Affiliations Biophytis

Trial Dates

  • Initiation Dates

    Actual : 16 Jun 2020

  • Primary Completion Dates

    Planned : 01 Jul 2021

  • End Dates

    Planned : 01 Sep 2021

Other Details

  • Design double-blind; multicentre; prospective; randomised; sequential
  • Phase of Trial Phase II/III
  • Location Belgium; Brazil; Europe; France; Latin America; Puerto Rico; United Kingdom; USA
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
SarconeosPrimary Drug Oral Capsule

BIO101

BIO101 350 mg bid
Drug: BIO101 (BIO101 capsules) Other Name: Sarconeos (BIO101)

Placebo

Placebo
Drug: Placebo (placebo capsules) Other Name: Sarconeos (placebo)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Alpesh Nair, MD University of California, Irvine USA
Arnaud Desclaux, MD Centre Hospitalier Universitaire Bordeaux France
Capucine Morelot-Panzini, MD Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière
-
Capucine Morélot-Panzini, MD Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital France
Christopher Lipinski, MD Abrazo Health USA
Claudio Stadnik, MD Santa Casa de Porto Alegre Brazil
DeVit, MD CHU Saint-Pierre Belgium
Edouard Devaud, MD Centre Hospitalier Rene Dubos France
Fernando Neuenschwander, MD Hospital Vera Cruz Brazil
Gaetan Plantefeve, MD Centre Hospitalier Argenteuil France
Girish Nair, MD Beaumont Health USA
Jean Martinot, MD
martinot.j@respisom.be
show details
CHU CLU Namur (Saint-Elisabeth) Place Louise Godin Belgium
Jeffrey Gray, MD United Health Services Hospitals USA
Lee Maddox WellSpan Health USA
Ludhmila A Hajjar, MD Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar Brazil
Maria Patelli Lima, MD Hospital e Maternidade Celso Pierro - PUCCAMP Brazil
Muriel Lins, MD
+3215892040 muriel.lins@Emmaus.be
show details
AZ-Sint Maarten Belgium
Nara Moraes, MD Hospital Municipal de Barueri Dr. Francisco Moran Brazil
Otis Barnum, MD Barnum Medical Research, Inc. 1029 Keyser Ave Suite H USA
Ricardo Fernandez, MD FDI Clinical Research - San Juan City Hospital Puerto-Rico
Shmuel Agus, MD
+16176424891
sam.agus@biophytis.com
show details
, Biophytis S.A.
-
Stéphane De Wit, MD CHU Saint-Pierre Belgium
Suzanna Lobo, MD Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto Brazil
Thomas Guimard, MD Centre Hospitalier Départemental de Vendée France
Valerie Pourchet, MD Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris France
Waly Dioh, PhD
+33144272339
waly.dioh@biophytis.com
show details
, Biophytis S.A.
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Abrazo Health Phoenix, Arizona USA
Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar São Paulo Brazil
AZ-Sint Maarten Mechelen Belgium
Barnum Medical Research, Inc. 1029 Keyser Ave Suite H Natchitoches, Louisiana USA
Beaumont Health Royal Oak, Michigan USA
Biophytis S.A.
+33(0)144 27 23 87
B.5.6 E-mail mounia.chabane@biophytis.com
show details
-
-
Centre Hospitalier Argenteuil Argenteuil France
Centre Hospitalier Départemental de Vendée La Roche-sur-Yon France
Centre Hospitalier Rene Dubos Cergy-Pontoise France
Centre Hospitalier Universitaire Bordeaux Bordeaux France
CHU CLU Namur (Saint-Elisabeth) Place Louise Godin Namur Belgium
CHU Saint-Pierre Brussel Belgium
CHU Saint-Pierre Brussels Belgium
Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière
-
-
FDI Clinical Research - San Juan City Hospital San Juan Puerto-Rico
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto São José Do Rio Preto, São Paulo Brazil
Hospital e Maternidade Celso Pierro - PUCCAMP Campinas, São Paulo Brazil
Hospital Municipal de Barueri Dr. Francisco Moran Barueri, São Paulo Brazil
Hospital Vera Cruz Belo Horizonte, Minas Gerais Brazil
Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris Paris France
Santa Casa de Porto Alegre Porto Alegre, Rio Grande Do Sul Brazil
United Health Services Hospitals Johnson City, New York USA
Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital Paris, Paris Cedex 13 France
University of California, Irvine Irvine, California USA
WellSpan Health York, Pennsylvania USA

Trial History

Event Date Event Type Comment
12 May 2021 Other trial event According to a Biophytis media release, final study results are expected in Q3 2021, subject to any COVID-19-related delays and the impact of the pandemic Updated 15 May 2021
12 May 2021 Other trial event According to a Biophytis media release, recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants, with the aim of filing for Emergency Use Authorization with the US Food and Drug Administration (FDA) and Conditional Approval with the European Medicines Agency (EMA) in Q3 2021. Updated 15 May 2021
12 May 2021 Other trial event According to a Biophytis media release, the company announces that it has recruited the 155th participant for Part 2 of this study. This allows the independent Data Monitoring Committee (DMC) to conduct its second interim analysis, based on safety and efficacy data, for the continuation of the trial in case of favorable results. The Company is to report the recommendations of the DMC based on its review of the second interim analysis results by the end of Q2 2021. Updated 15 May 2021
22 Mar 2021 Other trial event According to a Biophytis media release, the study results (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19-related delays and the impact of the current pandemic. Updated 24 Mar 2021
22 Mar 2021 Other trial event According to a Biophytis media release, upon the second interim analysis, based on the safety and efficacy data from 155 patients, the DMC will re assess the total size of the cohort, estimated today at 310 patients, and the continuation of the trial. Updated 24 Mar 2021
22 Mar 2021 Other trial event According to a Biophytis media release, the independent Data Monitoring Committee (DMC) for the COVA study has delivered a favorable opinion on the safety of Sarconeos (BIO101) in patients infected with COVID-19, following the scheduled interim analysis of the 50 participants from Part 1 of the study, as well as the progression of patients enrollment, which has now reached 97 of the 155 planned for the second interim analysis. A total of 28 clinical centers are now opened and recruiting. Updated 24 Mar 2021
24 Feb 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 24 Feb 2021
16 Feb 2021 Other trial event According to a Biophytis media release, results from the full study (Part 1 and Part 2) are expected in Q2 2021, subject to any delays in patient recruitment or retention, interruptions in sourcing or supply chain, regulatory authorizations and procedures, COVID-19-related delays, and the impact of the current pandemic. Updated 23 Feb 2021
16 Feb 2021 Other trial event According to a Biophytis media release, the company has received the regulatory authorization from the respective Regulatory Authorities in France and Belgium for part 2 study to begin patient recruitment at clinical centers. Similar regulatory authorization was obtained from Regulatory Authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and USA for most clinical centers. The trial is now recruiting for part 2 at France, Belgium, Brazil and USA. Updated 23 Feb 2021
03 Feb 2021 Other trial event According to a Biophytis media release, the interim analysis of Part 1 is expected in Q1 2021, subject to any COVID-19 related delays and the impact of the current pandemic on our operational capabilities. Updated 09 Feb 2021
03 Feb 2021 Other trial event According to a Biophytis media release, enrollment for Part 1 of the COVA Study has been completed with 50 patients recruited in 4 countries: Brazil, the USA, Belgium, and France. Following the Data Monitoring Committee (DMC) recommendation to begin the recruitment for Part 2, authorization is being obtained from regulatory authorities (national regulatory agencies and/or central IRB and/or local Ethics Committees) in Brazil and the USA for the start of Part 2. Updated 09 Feb 2021
03 Feb 2021 Other trial event According to a Biophytis media release, patient recruitment at most clinical centers in Brazil and the United States will begin for Part 2 of its COVA Study. Updated 09 Feb 2021
19 Jan 2021 Protocol amendment Eligibility criteria amended to include subjects from 45 years and above. Updated 27 Jan 2021
19 Jan 2021 Other trial event According to a Biophytis media release, results from the full study (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19 related delays and the impact of the current pandemic. Updated 21 Jan 2021
19 Jan 2021 Other trial event According to a Biophytis media release, the company received the recommendation by the DMC to start recruitment for Part 2 of this study. The DMC recommendation is based on its review of the safety data analysis from the first 20 patients enrolled in the study. Based on the DMC recommendation, BIOPHYTIS intends to start patient recruitment for Part 2 of this study in countries where applicable regulatory approvals, including Institutional Review Board/Ethics Committee approvals, are obtained. Updated 21 Jan 2021
15 Jan 2021 Other trial event Last checked against European Clinical Trials Database record. Updated 15 Jan 2021
11 Dec 2020 Other trial event According to a Biophytis media release, q total of 17 centers are now actively recruiting in Belgium, Brazil, France and the US among a targeted number of around thirty to be opened for the second part of the COVA study. Updated 18 Dec 2020
11 Dec 2020 Other trial event According to a Biophytis media release, In addition to the two first centers at the Pitie-Salpetriere University Hospital in Paris, Biophytis also received approval from the French National Agency for Medicines and Health Products Safety (ANSM) this month to open six new centers in France, among which Centre Hospitalier Rene Dubos and Centre Hospitalier d'Argenteuil in the Paris Region, bringing the total to eight centers planned to recruit COVID-19 patients in France. Updated 18 Dec 2020
11 Dec 2020 Other trial event According to a Biophytis media release, the first French patient has been dosed at La Pitie-Salpetriere University Hospital, Paris. Interim analysis and completion of full trial enrollment is expected in Q1 2021. Updated 18 Dec 2020
26 Oct 2020 Other trial event According to a Biophytis media release, the first patient in Brazil has been dosed at Hospital Maternidade Celso Pierro - PUCCAMP in Campinas, in this study. Updated 28 Oct 2020
13 Oct 2020 Other trial event According to a Biophytis media release, Dr Otis Barnum, MD, internist in Natchitoches, Louisiana is the Principal Investigator Coordinator of COVA in US. Updated 19 Oct 2020
13 Oct 2020 Other trial event According to a Biophytis media release, the trial has been making good progress with now seven centers open and ready to recruit COVID-19 patients in Belgium, France, Brazil and in the US. Updated 19 Oct 2020
13 Oct 2020 Other trial event According to a Biophytis media release, first US patient has been enrolled in this study at Natchitoches Regional Medical Center, Barnum Medical Research, in Louisiana (US). Updated 19 Oct 2020
01 Sep 2020 Other trial event According to a Biophytis media release, the first patient has been dosed at AZ Sint Maarten hospital in Mechelen, Belgium. The trial now has five centers ready for patients recruitment in Belgium, France and the US. Updated 04 Sep 2020
06 Aug 2020 Other trial event Planned number of patients changed from 310 to 465. Updated 06 Aug 2020
03 Aug 2020 Other trial event According to a Biophytis media release, Ludhmila Abrahaao Hajjar, MD, PhD, Professor at the Faculty of Medicine University of Sao Paulo, (InCor HCFMUSP, Sao Paulo, Brazil), is COVA's Principal Investigator and National Coordinator in Brazil. Updated 05 Aug 2020
03 Aug 2020 Other trial event According to a Biophytis media release, the company has received approval from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), to start its clinical development program COVA in Brazil. Updated 05 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the first part of the COVA study, which has already started in Belgium, the UK, and the USA, will provide the company with important preliminary data as the company works to confirm that Sarconeos (BIO101) can successfully prevent the deterioration of the respiratory function in Covid-19 patients. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the study is to start in France mostly with the La Pitie-Salpetriere Hospital, which is linked with Sorbonne Universitys medical school, a long-standing partner of Biophytis. The authorization comes at a crucial moment of COVID-19 upsurge in France and in Europe, re-emphazing the emergency of finding innovative treatments against the pandemics. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the second interim analysis will be conducted half way of the second part and will assess the final size of the cohort, estimated at this stage to 310 patients. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the first interim analysis will be conducted when the first 50 participants finish the study intervention period. Upon the green light to proceed, delivered by the DMC based on safety data, the Company can then continue recruiting into the second part. This analysis can also provide an initial proof of activity of Sarconeos (BIO101) on the study participants. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the COVA study is an adaptive study with 2 planned interim analyses that will be conducted by an independent data-monitoring committee (DMC). Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, this is a two-stage study that will be coordinated by Dr. Capucine Morelot-Panzini, Professor of Pulmonology at the Pitie-Salpetriere University Hospital in Paris and Principal Investigator of COVA in France. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, this phase 2/3, adaptive and seamless study is expected to start in the coming weeks in France. Updated 04 Aug 2020
27 Jul 2020 Other trial event According to a Biophytis media release, the company has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with its clinical development program: COVA. The program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19. Updated 04 Aug 2020
17 Jul 2020 Other trial event New source identified and integrated(ClinicalTrials.gov: US National Institutes of Health;NCT04472728). Updated 17 Jul 2020
13 Jul 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 04 Aug 2020
02 Jul 2020 Other trial event According to a Biophytis media release, the company has received 6.1 euros million private placement. The company plans to used this net proceeds for the progress of this study. Updated 07 Jul 2020
01 Jul 2020 Other trial event According to a Biophytis media release, the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application and received IND clearance to proceed this trial. Updated 01 Sep 2020
01 Jul 2020 Other trial event According to a Biophytis media release, company has already initiated the work to start this trial as soon as possible in the US, and in the European countries where approval has been received, and will update the market shortly on planned timelines. Updated 07 Jul 2020
11 Jun 2020 Other trial event According to a Biophytis media release, this trial is expected to start in the coming weeks in the UK, upon approval of the relevant ethics committees. Updated 12 Jun 2020
11 Jun 2020 Other trial event According to a Biophytis media release, the company has filed clinical trial applications with the FDA in the US. Updated 12 Jun 2020
11 Jun 2020 Other trial event According to a Biophytis media release, the company received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with this trial. Updated 12 Jun 2020
09 Jun 2020 Other trial event Planned number of patients changed from 545 to 310. Updated 09 Jun 2020
22 May 2020 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2020-001498-63). 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. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Biophytis. Biophytis Receives Approval from the French Health Authority (ANSM) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  3. Biophytis. Biophytis Enrolls First Patient in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  4. Biophytis. Biophytis Receives Approval from Brazilian Health Regulatory Agency to Start COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  5. Biophytis. Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  6. Biophytis. BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos (BIO101) in COVID-19 allowing the 2nd Interim Analysis. Media-Rel 2021;.

    Media Release
  7. European Clinical Trials Database. Trial-Reg 2021;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  8. Biophytis. Biophytis - First Patient Enrolled in France in COVA, an International Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  9. 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
  10. Biophytis. BIOPHYTIS receives DMC recommendation for starting recruitment for Part 2 of its Phase 2-3 COVA study in COVID-19. Media-Rel 2021;.

    Media Release
  11. Biophytis. Biophytis Receives MHRA Approval to Initiate the COVA Clinical Trial in the UK with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  12. Biophytis. Biophytis - Last patient completes final visit in SARA-INT, a Phase 2 clinical trial evaluating the efficacy of Sarconeos (BIO101) in thetreatment of sarcopenia. Media-Rel 2020;.

    Media Release
  13. Biophytis. Biophytis Announces the Start of Patient Recruitment in Brazil and the USA for Part 2 of the Phase 2-3 COVA Trial (COVA Study). Media-Rel 2021;.

    Media Release
  14. Biophytis. BIOPHYTIS Gives Updates on its Phase 2-3 COVA Study on COVID-19. Media-Rel 2021;.

    Media Release
  15. Biophytis. Biophytis - First US Patient Enrolled in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  16. Biophytis. Biophytis Announces a 6.1 Million Capital Increase Through Private Placement. Media-Rel 2020;.

    Media Release
  17. 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
  18. Biophytis. Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial (COVA Study) Following Regulatory Authorities Approvals in France and Belgium. Media-Rel 2021;.

    Media Release
  19. Biophytis. Biophytis Enrolls First Patient in Brazil in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Media-Rel 2020;.

    Media Release
  20. Biophytis. Biophytis Launches COVA Clinical Study with Sarconeos (BIO101) in Covid-19. Media-Rel 2020;.

    Media Release
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