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COVID-19Phase 2NCT05279352

Safety and Pharmacokinetics of FBR-002 for the Treatment of Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

A Phase 2 study testing FBR-002 in people with COVID-19, run by Fab'entech at 6 sites in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus associated with COVID-19 (Coronavirus Disease 2019), invading the respiratory tract, and leading to symptoms from dysgeusia, anosmia, fever, headache and cough to dyspnea and severe respiratory failure and even death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
FBR-002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
6 sitesGreece
Study dates
21 Mar 2022to 15 Jul 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • I1. Male or female ≥ 18 years
  • greater than or equal to 70 years of age with or without any risk factor
  • or less than 70 years of age and the presence of at least one of the following risk factors:
  • Arterial hypertension under treatment (all stages)
  • Obesity (body mass index [BMI] ≥30 kg/m²) or severe obesity (BMI of ≥40 kg/m²)
  • Diabetes (all types)
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  • Heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension)
  • Stroke or cerebrovascular disease History
  • Chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
  • Malignancies (solid tumors or blood malignancies) that are progressive or were diagnosed less than 5 years ago
  • Immunocompromised state (this includes patients who are suffering from primary immunodeficiencies; patients under treatment with corticosteroids either oral or parenteral; patients receiving active chemotherapy; patients on biological treatment or treatment with Janus Kinase (JAK) inhibitors)
  • Solid organ or blood stem cell transplant
  • Down syndrome
  • Known human immunodeficiency virus (HIV) infection
  • Liver disease of stage 1 and 2 based on the Child-Pugh classification (Appendix C)
  • Hemoglobin blood disorders (Thalassemia, Sickle Cell Disease, etc)
  • Renal disease (grade 1 and 2 according to Kidney Disease Improving Global Outcomes (KDIGO) classification) (see Appendix D)
  • Dementia or other neurological conditions
  • Absence of anti-SARS-CoV2 IgM or IgG at screening
  • I2. Written informed consent provided by the patient or by a legal representative
  • I3. Biologically confirmed SARS-CoV-2 infection ≤ 10 days before screening
  • I4. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, fatigue, the new loss of taste or smell
  • I5. Findings in chest-X-ray or chest computed tomography compatible with lower respiratory tract infection* * precision for imaging: typical imaging features related to COVID-19
  • I6. Patient admitted to hospital for COVID-19, but outside of the Intensive Care Unit
  • I7. Patient requiring low-flow O2 supplementation ≤ 6L/min by mask or nasal prongs at screening
  • I8. The score of 5 on the WHO 11-point Clinical Progression Scale at screening

Who cannot join

  • E1. Score ≥ 6 on the WHO 11-point Clinical Progression Scale at screening
  • E2. Respiration rate > 30 breaths/min in adults under low-flow (⩽ 6 L/min) oxygen
  • E3. Liver failure of stage 3 according to the Child-Pugh classification
  • E4. Severe renal failure (≥ grade 3 according to KDIGO classification)
  • E5. Treatment with anti-SARS-CoV-2 immunoglobulins or any blood-derived products in the last 90 days
  • E6. Any anti-SARS-CoV-2 vaccine injection performed less than 21 days before screening
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  • E7. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
  • E8. Known allergy or hypersensitivity or intolerance to study product components
  • E9. History of anaphylaxis during a prior administration of equine serum (i.e., anti- tetanus serum or anti-ophidic serum or anti-arachnid toxin serum or anti-rabies serum) or allergic reaction due to contact or exposure to horses
  • E10. Participation in any other Interventional study with an investigational product in the last 30 days or within 5 half-lives of receiving the investigational product
  • E11. Patients with short life expectancy or with any severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study
  • E12. Septic shock

Trial locations and contacts

6 sites in 1 country.

Cécile Herbreteau-Delale contact

+33 4 37 70 67 67

cecile.herbreteau-delale@fabentech.com

6 sites in 1 country

Greece6 sites, 6 recruiting

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

    Periklis Panagopoulos

    Periklis Panagopoulos

    Recruiting

  • "Sotiria" General Hospital of Chest Diseases of Athens

    Athens, 115 27

    Garyfallia Poulakou

    Garyfallia Poulakou

    Recruiting

  • University General Hospital of Athens ATTIKON

    Athens, 12462

    Evangelos Giamarellos-Bourboulis, +30 210 5831985, egiamarel@med.uoa.gr

    Evangelos Giamarellos-Bourboulis

    Recruiting

  • University General Hospital of Patras

    Pátrai, 26504

    Karolina Akinosoglou

    Karolina Akinosoglou

    Recruiting

  • "Tzaneio" General Hospital of Piraeus

    Piraeus, 185 36

    Georgios Chrysos

    Georgios Chrysos

    Recruiting

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki

    Simeon Metallidis

    Simeon Metallidis

    Recruiting

Other trials in Greece

About this study

Official title: A Two-stage Randomized, Placebo-controlled, Double-blind, Phase 2a Study to Characterize the Safety and Pharmacokinetics of FBR-002 in Patients Hospitalized With COVID-19 in Need of Supplemental Oxygen and at Risk of Severe Outcome

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus associated with COVID-19 (Coronavirus Disease 2019), invading the respiratory tract, and leading to symptoms from dysgeusia, anosmia, fever, headache and cough to dyspnea and severe respiratory failure and even death. In order to obtain its pathogenic activity, the SARS-CoV-2 relies on its spike protein to enter the cells of the infected patient. This infection leads to a variable severity spectrum, with the majority of forms of mild entity (upper respiratory tract infection or lower respiratory tract without respiratory failure or insufficiency of other organs) despite the presence of a considerable share of severe infections in need hospitalization in sub-intensive or intensive area (up to 6% of cases) with invasive and non-invasive respiratory support. Approximately 14% of patients have experienced severe disease and 5% have been critically ill.

In the context of global pandemic, Fab'entech is currently developing polyclonal F(ab')2 equine fragments directed against the SARS-CoV-2 spike protein. Indeed, as virus entry within the cell requires this protein, Fab'entech proposes a way to block this event, neutralizing viral replication, and therefore inhibiting pathogenic activity of the virus.

The objective of this two-stage randomized, placebo-controlled, double blind, phase 2a study is to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome

Conditions
COVID-19
Being tested
FBR-002, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FBR-002Drug

    Administration on D1 and D3

  • PlaceboDrug

    Administration on D1 and D3

Study groups in NCT05279352
Study groupRoleWhat they receive
Treatment ArmExperimentalFBR-002 at 4.3 EU/kg on D1 and D3 or FBR-002 at 5.7 EU/kg on D1 and D3
Receives: Drug: FBR-002
Placebo ArmPlacebo comparatorTwo administrations of placebo at D1 and D3
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events of FBR-002

    The rate of treatment-emergent adverse events (serious and non-serious) of FBR-002 in the two groups of treated patients and vs. placebo over 14 days

    Measured: Day 1 to Day 14

Secondary outcomes (5)

  1. Pharmacokinetics of FBR-002

    To characterize the pharmacokinetics (PK) profile of FBR-002 on SARS-CoV-2 infected patients over time from Day D1 to D14, including the mean plasmatic concentration of FBR002 of at least 2.6 μg/mL between Day 1 and Day 7 in treated groups;

    Measured: Day 1 to Day 14

  2. Biomarkers

    The comparison of the relative changes of biomarkers over the time from D1 to D14 between patients treated with placebo and patients treated with each of the two dose regimens of FBR-002

    Measured: Day 1 to Day 14

  3. Viral load

    The comparison of viral load over the time from D1 to D14 between patients treated with placebo and patients treated with each of the two dose regimens of FBR-002

    Measured: From Day 1 to Day 14

  4. Efficacy of FBR-002

    The comparison of the rate of patients progressing into WHO-CPS ≥6 by Day 8 between patients treated with placebo and patients treated with either dose of FBR-002

    Measured: Day 8

  5. Efficacy of FBR-002

    The comparison of the rate of patients with an improvement of at least two points based on the WHO 11-point ordinal CPS i.e., hospital discharge between patients treated with placebo and patients treated with either dose of FBR-002; this is censored at 7 days after the administration of the first dose (Day 8).

    Measured: Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start21 Mar 2022
  3. Primary completion15 Jun 2022 (estimated)
  4. Study completion15 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279352
Sponsor's protocol ID
E21-04
Status last verified
Mar 2022
First submitted
14 Mar 2022
Last updated
4 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Herbreteau CH, Jacquot F, Rith S, Vacher L, Nguyen L, Carbonnelle C, Lotteau V, Jolivet M, Raoul H, Buchy P, Saluzzo JF. Specific polyclonal F(ab')2 neutralize a large panel of highly pathogenic avian influenza A viruses (H5N1) and control infection in mice. Immunotherapy. 2014;6(6):699-708. doi: 10.2217/imt.14.40. Epub 2014 Mar 27.

    PubMed 24673720

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FBR-002 in people with COVID-19, run by Fab'entech at 6 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cécile Herbreteau-Delale (+33 4 37 70 67 67, cecile.herbreteau-delale@fabentech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events of FBR-002 (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05279352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.

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