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

NCT05279352 | Unknown Phase 2 DMC

• 1 other identifier: E21-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief 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. 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

Outcome Measures

Primary Outcomes (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

  Day 1 to Day 14

Secondary Outcomes (5)

• Pharmacokinetics of FBR-002

  Day 1 to Day 14

• Biomarkers

  Day 1 to Day 14

• Viral load

  From Day 1 to Day 14

• Efficacy of FBR-002

  Day 8

• Efficacy of FBR-002

  Day 8

Study Arms (2)

Treatment Arm

EXPERIMENTAL

FBR-002 at 4.3 EU/kg on D1 and D3 or FBR-002 at 5.7 EU/kg on D1 and D3

Drug: FBR-002

Placebo Arm

PLACEBO COMPARATOR

Two administrations of placebo at D1 and D3

Drug: Placebo

Interventions

FBR-002 DRUG

Administration on D1 and D3

Treatment Arm

Placebo DRUG

Administration on D1 and D3

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fab'entech: lead

Study Sites (6)

University General Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

RECRUITING

"Sotiria" General Hospital of Chest Diseases of Athens

Athens, 115 27, Greece

RECRUITING

University General Hospital of Athens ATTIKON

Athens, 12462, Greece

RECRUITING

University General Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

"Tzaneio" General Hospital of Piraeus

Piraeus, 185 36, Greece

RECRUITING

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 24673720 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

FBR-002

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Evangelos Giamarellos-Bourboulis, Prof

  University General Hospital of Athens ATTIKON

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Herbreteau-Delale

CONTACT

+33 4 37 70 67 67; cecile.herbreteau-delale@fabentech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 15, 2022
• Study Start: March 21, 2022
• Primary Completion: June 15, 2022
• Study Completion: July 15, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

GR (6)