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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
Enrollment
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Inclusion criteria
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:
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
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Central trial contact
Cécile Herbreteau-Delale
Data sourced from clinicaltrials.gov
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