The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
290
Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement
Dimitrovgrad, Bulgaria
Proportion of patients with an aggravation of COVID-19
The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO 7-point ordinal scale at randomization.
Time frame: within 8 days after treatment
Change in Clinical parameters : body temperature
°C
Time frame: Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : Respiratory rate
breath/min
Time frame: Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : SpO2 at ambiant air
Time frame: Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : Supplemental O2
L/min
Time frame: Between randomization and Day 3, 5, 8 and 15
Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0)
Shortness of breath and thoracic pain Scale score : Dyspnea: grade 1 (shortness of breath with moderate exertion) to 5 (death) Non-cardiac chest pain: grade 1 (mild pain) to 3 (severe pain)
Time frame: Between randomization and Day 3, 5, 8 and 15
Duration of patient's requirement in supplemental O2
Time requiring supplemental O2 at Day 15 will be defined as the time in days from randomization to the date of requiring supplemental O2.
Time frame: up to 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement
Plovdiv, Bulgaria
Complex Oncological Center - Ruse Ltd, COVID Departement
Rousse, Bulgaria
Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology
Rousse, Bulgaria
5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric
Sofia, Bulgaria
Evangelismos General Hospital of Athens, Critical Care Departement
Athens, Greece
"Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens
Athens, Greece
University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit
Heraklion, Greece
AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department
Thessaloniki, Greece
"Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics
Thessaloniki, Greece
...and 8 more locations
Duration of aggravation
Duration of aggravation will be defined as the time in days between start date of aggravation and improvement date.
Time frame: up to 15 days
Length of hospital stay
Time frame: up to 15 days
Viral status: RT-PCR or RT-qPCR for SARS-CoV-2
(positive/negative)
Time frame: At randomization and on Day 8 or at the end of follow-up, whichever comes first
Proportion of patients referred to Intensive Care Unit (ICU)
Time frame: Between randomization and Day 3, 5, 8 and 15
Proportion of patients with need for mechanical ventilation
Time frame: At randomization and at Day 3, 5, 8 and 15
Survival rates
Time frame: at day 8 and day 15 after randomization
Safety: Occurrence of adverse effects
Number and Proportion of participants with AE, SAE and treatment emergent adverse events leading to study drug discontinuation, to concomitant or additional treatment
Time frame: up to 15 days
Safety: hypersensitivity or allergy
Incidence of hypersensitivity reactions and allergy
Time frame: up to 15 days
Safety: laboratories abnormalities : white blood cell count
G/L
Time frame: up to 15 days
Safety: laboratories abnormalities : red blood cell count
10 12/L
Time frame: up to 15 days
Safety: laboratories abnormalities : hemoglobin
g/dL
Time frame: up to 15 days
Safety: laboratories abnormalities : platelets
G/L
Time frame: up to 15 days
Safety: laboratories abnormalities : creatinine
µmol/L
Time frame: up to 15 days