Safety and pharmacokinetics of FBR-002 for the treatment of patients hospitalized with COVID-19 need of supplemental oxygen and at risk of severe outcome

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 need of supplemental oxygen and at risk of vere outcome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002390-25-GR

Enrollment

Registered

2021-12-01

Start date

2022-01-20

Completion date

Unknown

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 in hospitalized patients in need of supplemental oxygen and at risk of severe outcome MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: FBR-002 Product Code: FBR-002 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Anti-SARS-CoV-2 F(ab')2 fragments Other descriptive name: Anti-SARS-CoV-2 polyclonal immunog

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: I1. Male or female = 18 years : - = 70 years of age without any risk factor - or =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: E1. Score = 6 on the WHO 11-point Clinical Progression Scale at screening; E2. Respiration rate > 30 breaths/min in adults under adequate oxygen; E3. Liver failure > 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 ; 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. No parallel participation to any other investigational clinical study; 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of E21-04 study is to assess the safety and tolerability of two different dose regimens of FBR-002 when given to patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome until day 14. ;Secondary Objective: The study has three secondary objectives: a)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; b)To investigate the impact of FBR-002 on biomarkers and viral load; c)To generate proof-of-concept for the potential clinical efficacy of FBR-002 in these patients ;Primary end point(s): The primary study endpoint is to assess the safety and tolerability of two different dose regimens of FBR-002, when given to patients with COVID-19 need of oxygen supplementation at screening, until day 14. This will be measured by the comparaison of the rate of serious and non-serious treatment-emergent adverse events between patients treated with placebo and patient treated with each of the two doses of FBR-002.;Timepoint(s) of evaluation of this end point: Day 14	—

Measure

Time frame

Main Objective: The primary aim of E21-04 study is to assess the safety and tolerability of two different dose regimens of FBR-002 when given to patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome until day 14. ;Secondary Objective: The study has three secondary objectives: a)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; b)To investigate the impact of FBR-002 on biomarkers and viral load; c)To generate proof-of-concept for the potential clinical efficacy of FBR-002 in these patients ;Primary end point(s): The primary study endpoint is to assess the safety and tolerability of two different dose regimens of FBR-002, when given to patients with COVID-19 need of oxygen supplementation at screening, until day 14. This will be measured by the comparaison of the rate of serious and non-serious treatment-emergent adverse events between patients treated with placebo and patient treated with each of the two doses of FBR-002.;Timepoint(s) of evaluation of this end point: Day 14

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Secondary

Measure	Time frame
Secondary end point(s): The secondary study endpoints are: a)The calculation of Cmax, Tmax, t1/2, AUC[0-24], AUC[0-infinity], CL, Vd of each of the two different dose regimens of FBR-002; b)The rate of patients with the ability to maintain a mean plasmatic concentration of at least 2.6 µg/mL of FBR-002 until Day 7* in each of the two different dose regimens of FBR-002; *A concentration more or equal to 2,6 µg/mL has been described by Fab’entech as sufficient to reach 3 times the EC90 against Delta variant, and thus to block viral replication. c)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- d)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; e)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 FBR002; f)The comparison of the rate of patients with an improvement of at least two points based on the WHO 11-point ordinal CPS or the rate i.e. hospital discharge between patients treated with placebo and patients treated with either dose of FBR002; this is censored at 7 days after the administration of the first dose (Day 8). Hospital discharge is defined as the achievement of a WHO clinical progression score of =3 even if the patients is transferred to a patient ward or care services for social and/or previous health issues ;Timepoint(s) of evaluation of this end point: a) D1 to D14 b) D1 to D7 c) D1 to D14 d) D1 to D14 e) D8 f) D1 and D8	—

Measure

Time frame

Secondary end point(s): The secondary study endpoints are: a)The calculation of Cmax, Tmax, t1/2, AUC[0-24], AUC[0-infinity], CL, Vd of each of the two different dose regimens of FBR-002; b)The rate of patients with the ability to maintain a mean plasmatic concentration of at least 2.6 µg/mL of FBR-002 until Day 7* in each of the two different dose regimens of FBR-002; *A concentration more or equal to 2,6 µg/mL has been described by Fab’entech as sufficient to reach 3 times the EC90 against Delta variant, and thus to block viral replication. c)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- d)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; e)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 FBR002; f)The comparison of the rate of patients with an improvement of at least two points based on the WHO 11-point ordinal CPS or the rate i.e. hospital discharge between patients treated with placebo and patients treated with either dose of FBR002; this is censored at 7 days after the administration of the first dose (Day 8). Hospital discharge is defined as the achievement of a WHO clinical progression score of =3 even if the patients is transferred to a patient ward or care services for social and/or previous health issues ;Timepoint(s) of evaluation of this end point: a) D1 to D14 b) D1 to D7 c) D1 to D14 d) D1 to D14 e) D8 f) D1 and D8

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Countries

Greece

Contacts

Public ContactHead of Research and Development

Fab'entech

Cecile.Herbreteau-Delale@fabentech.com33437707551

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026