Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, polyclonal IgG
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Sites / Locations
- Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement
- University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement
- Complex Oncological Center - Ruse Ltd, COVID Departement
- Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology
- 5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric
- Evangelismos General Hospital of Athens, Critical Care Departement
- "Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens
- University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit
- AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department
- "Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics
- Leon Daniello Clinical Hospital of Pneumoftiziology
- Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova
- Military Field Hospital ROL-2
- Pius Brinzeu County Emergency Clinical Hospital Timisoara
- Ramón y Cajal University Hospital
- Puerta del Hierro University Hospital
- Bağcılar Medipol Mega Universite Hastanesi
- Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
XAV-19
Placebo
XAV-19