Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
- Registration Number
- NCT04928430
- Lead Sponsor
- Xenothera SAS
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of XAV-19 drug in patients with moderate-to-severe COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 290
I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent,
I2) Patient presenting in a specialized or an emergency unit
I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea
I4) Patient with SpO2 > 90% (at ambient air)
I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening
I6) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and use a highly effective birth control until 90 days after the administration of study drug
I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,
I8) Patient capable of giving signed informed consent.
E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit
E2) Patient with multiorgan failure
E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization
E4) Patient participating in another clinical trial with an investigative agent
E5) Pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - XAV-19 XAV-19 XAV-19
- Primary Outcome Measures
Name Time Method Proportion of patients with an aggravation of COVID-19 within 8 days after treatment 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.
- Secondary Outcome Measures
Name Time Method Change in Clinical parameters : body temperature Between randomization and Day 3, 5, 8 and 15 °C
Change in Clinical parameters : Respiratory rate Between randomization and Day 3, 5, 8 and 15 breath/min
Change in Clinical parameters : SpO2 at ambiant air Between randomization and Day 3, 5, 8 and 15 Change in Clinical parameters : Supplemental O2 Between randomization and Day 3, 5, 8 and 15 L/min
Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0) Between randomization and Day 3, 5, 8 and 15 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)Duration of patient's requirement in supplemental O2 up to 15 days Time requiring supplemental O2 at Day 15 will be defined as the time in days from randomization to the date of requiring supplemental O2.
Duration of aggravation up to 15 days Duration of aggravation will be defined as the time in days between start date of aggravation and improvement date.
Length of hospital stay up to 15 days Viral status: RT-PCR or RT-qPCR for SARS-CoV-2 At randomization and on Day 8 or at the end of follow-up, whichever comes first (positive/negative)
Proportion of patients referred to Intensive Care Unit (ICU) Between randomization and Day 3, 5, 8 and 15 Proportion of patients with need for mechanical ventilation At randomization and at Day 3, 5, 8 and 15 Survival rates at day 8 and day 15 after randomization Safety: Occurrence of adverse effects up to 15 days Number and Proportion of participants with AE, SAE and treatment emergent adverse events leading to study drug discontinuation, to concomitant or additional treatment
Safety: hypersensitivity or allergy up to 15 days Incidence of hypersensitivity reactions and allergy
Safety: laboratories abnormalities : white blood cell count up to 15 days G/L
Safety: laboratories abnormalities : red blood cell count up to 15 days 10 12/L
Safety: laboratories abnormalities : hemoglobin up to 15 days g/dL
Safety: laboratories abnormalities : platelets up to 15 days G/L
Safety: laboratories abnormalities : creatinine up to 15 days µmol/L
Trial Locations
- Locations (18)
Complex Oncological Center - Ruse Ltd, COVID Departement
🇧🇬Ruse, 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
Pius Brinzeu County Emergency Clinical Hospital Timisoara
🇷🇴Timisoara, Romania
Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova
🇷🇴Craiova, Romania
Military Field Hospital ROL-2
🇷🇴Otopeni, Romania
Bağcılar Medipol Mega Universite Hastanesi
🇹🇷Bağcılar, Turkey
Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology
🇧🇬Ruse, Bulgaria
Puerta del Hierro University Hospital
🇪🇸Majadahonda, Spain
Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement
🇧🇬Dimitrovgrad, Bulgaria
University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement
🇧🇬Plovdiv, Bulgaria
5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric
🇧🇬Sofia, Bulgaria
Leon Daniello Clinical Hospital of Pneumoftiziology
🇷🇴Cluj-napoca, Romania
"Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics
🇬🇷Thessaloniki, Greece
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
🇹🇷Fatih, Turkey
Ramón y Cajal University Hospital
🇪🇸Madrid, Spain