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
Conditions
Sponsors
Fab'entech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Male or female =18 years old and = 90 years old •=70 years old with or without any risk factor •Or <70 years old and the presence of at least one of the following risk factors from the medical history: oTreated arterial hypertension (all stages); oObesity (Body Mass Index [BMI] = 30kg/m²) or severe obesity (BMI = 40 kg/m²); oAll types of diabetes (type 1 and type 2); oAny history of heart conditions disease (such as heart failure, coronary artery disease, cardiomyopathies or hypertension); oStroke or cerebrovascular disease history; oChronic lung diseases, including but not limited to COPD (chronic obstructive pulmonary disease), asthma (moderate to severe), interstitial lung disease, cystic fibrosis and pulmonary hypertension; oMalignancies: solid tumor that are progressive or treated within the year prior to participant screening/or blood malignancies that are progressive or treated within the 3 years prior to participant screening in the study; oImmunocompromised state (this includes participants who are suffering from primary immunodeficiencies; participants under treatment with corticosteroids either oral or parenteral (at least 10 mg per day prednisone-equivalent for at least 14 days prior to randomization); participants receiving active chemotherapy; participants on biological treatment or treatment with JAK inhibitors); oSolid organ or blood stem cell transplant; oDown syndrome; oKnown HIV infection; oLiver failure of stage 1 and 2 based on the Child-Pugh classification; oRenal failure (grade 1, 2, 3a and 3b according to KDIGO classification); oHemoglobin blood disorders (like Thalassemia, Sickle Cell Disease…); oDementia or other neurological conditions; oAbsence of anti-SARS-CoV2 IgM or IgG at screening; I2. Participant must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provide written informed consent (provided by the participant or by a legal representative); I3. Biologically confirmed SARS-CoV-2 infection = 10 days before screening (either by PCR or antigenic test); I4. First onset of COVID-19 symptoms = 10 days, like fever and/or chills, headache, myalgia, cough, shortness of breath, fatigue, new loss of taste or smell; I5. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection (precision for imaging: typical imaging features related to COVID-19); I6. Participant admitted to hospital for COVID-19, but outside of the Intensive Care Unit; I7. Participant requiring low-flow O2 supplement = 6L/min by mask or nasal prongs at screening; I8. Score of 5 on the WHO 11-point Clinical Progression Scale at screening; I9. Female of childbearing potential must have a serum negative pregnancy test at screening. Male and female of childbearing potential must use a highly effective method of contraception during treatment and at least for 1 month after the last dose of study treatment; I10. Participant must not be receiving therapy in a concurrent clinical trial at the time of screening and also 30 days prior to the screening and must agree not to participate in any other interventional clinical studies during their participation in this trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subje
Exclusion criteria
Exclusion criteria: E1. Score 30 breaths/min in adults under adequate oxygen; E3. Liver failure > stage 3 according to the Child-Pugh classification; E4. Severe renal failure (= grade 4 according to KDIGO classification); E5. Any anti-SARS-CoV-2 vaccine injection performed less than 21 days prior to screening; E6. Known allergy or hypersensitivity or intolerance to study product components; E7. History of anaphylaxis during or prior administration of equine serum (i.e anti-tetanus serum or anti-ophidic serum or anti-arachnid toxic serum or anti-rabies serum) or allergic reaction due to contact or exposure to horses; E8. Participants with short life expectancy or with any severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the participant’s participation to the study; E9. Septic shock ongoing at the time of screening or within the last 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of FBR-002 compared to placebo on the WHO-CPS in participants hospitalized with COVID-19 in need of supplemental oxygen at Day 28 after randomization;Secondary Objective: To determine the effect of FBR-002 compared to placebo on: the WHO-CPS in participants hospitalized with COVID-19 in need of supplemental oxygen between Day 0 and Day 14 To determine the effect of FBR-002 on: •The need for SoC intensification up to Day 14 •The disease progression within 28 days after randomization. •The overall survival at 28, 60 and 90 days after randomization. •The mortality rate related to respiratory failure due to COVID-19 within 90 days after randomization. •The WHO-CPS at Day 60 after randomization. •The time to hospital discharge within 60 days post-randomization. •The frailty of participants •Viral variants and viral load reduction. •The incidence and time to being free of any respiratory support. •SpO2/FiO2-ratio at days 3, 5 and 8 after randomization. •The occurrence of clinical and laboratory adverse events, including serious adverse events especially those leading to discontinuation of study treatment or to death. ;Primary end point(s): The distribution of frequencies of the WHO-CPS from 1 to 10 at Day 28 after randomization;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: •[2.1.1] Mean area under the curve (AUC) of WHO-CPS Day 0 to Day 14 •[2.1.2] The distribution of frequencies of the WHO-CPS (from 1 to 10) at Day 14 after randomization Other secondary endpoints: •[2.2] Proportion of participants that needed a SoC intensification up to Day 14 •[2.3.1] Time from Day 0 to occurrence of disease progression within 28 days from randomization •[2.3.2] Percentage of participants who have progressed their WHO-CPS to more or equal to 6 within 7, 14 and 28 days after randomization •[2.4] Overall survival at 28, 60 and 90 days from randomization. •[2.5] Mortality rate related to respiratory failure due to COVID-19 up to 90 days from randomization. •[2.6] The distribution of frequencies of the WHO-CPS (from 1 to 10) at Day 60 after randomization •[2.7] Time from Day 0 to hospital discharge within 60 days post-randomization. •[2.8] Evolution of mean clinical frailty score from Day 0 to day 28 •[2.9.1] Variant identification determined at Day 1 and Day 14, or early discontinuation visit (EDV). •[2.9.2] Mean viral load as assessed by SARS-CoV-2 RT-qPCR during hospitalization. •[2.9.3] Association between FBR-002 treatment and the proportion of participants with a variant at Day 14 (or EDV) different from the one at Day 1 •[2.9.4] Association between viral load and baseline viral variant. •[2.10.1] Cumulative incidence of being free of any respiratory support •[2.10.2] Time to being free of any respiratory support. •[2.11] Mean changes from randomization of SpO2/FiO2-ratio at days 3, 5 and 8 after randomization. •[2.12] Occurrence of clinically significant laboratory abnormalities, and adverse events, including serious adverse events (SAEs) especially those leading to discontinuation of study treatment or to death. ;Timepoint(s) of evaluation of this end point: •[2.1.1] Day 0 to Day 14 •[2.1.2] at Day 14 •[2.2]Day 0 to Day 14 •[2.3.1] Day 0 to Day 28 •[2.3.2] Day 7, Day 14 and Day 28 •[2.4] Da | — |
Countries
Greece
Contacts
Public ContactClinical Trial Manager
Fab'entech
Outcome results
None listed