Clinical trial NCT04928430: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
Official title: An International, Placebo-controlled, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of 150 mg XAV-19 Infusion, in Patients With Moderate to Severe COVID-19: the EUROXAV Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
polyclonal IgG
Lead sponsor: Xenothera SAS
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase II/III, multicenter, international, randomized (1:1), placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of XAV-19 in patients with moderate-to-severe COVID-19.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients with an aggravation of COVID-19
timeFrame: within 8 days after treatment
Secondary outcomes:
measure: Change in Clinical parameters : body temperature
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Change in Clinical parameters : Respiratory rate
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Change in Clinical parameters : SpO2 at ambiant air
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Change in Clinical parameters : Supplemental O2
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0)
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Duration of patient's requirement in supplemental O2
timeFrame: up to 15 days
measure: Duration of aggravation
timeFrame: up to 15 days
measure: Length of hospital stay
timeFrame: up to 15 days
measure: Viral status: RT-PCR or RT-qPCR for SARS-CoV-2
timeFrame: At randomization and on Day 8 or at the end of follow-up, whichever comes first
measure: Proportion of patients referred to Intensive Care Unit (ICU)
timeFrame: Between randomization and Day 3, 5, 8 and 15
measure: Proportion of patients with need for mechanical ventilation
timeFrame: At randomization and at Day 3, 5, 8 and 15
measure: Survival rates
timeFrame: at day 8 and day 15 after randomization
measure: Safety: Occurrence of adverse effects
timeFrame: up to 15 days
measure: Safety: hypersensitivity or allergy
timeFrame: up to 15 days
measure: Safety: laboratories abnormalities : white blood cell count
timeFrame: up to 15 days
measure: Safety: laboratories abnormalities : red blood cell count
timeFrame: up to 15 days
measure: Safety: laboratories abnormalities : hemoglobin
timeFrame: up to 15 days
measure: Safety: laboratories abnormalities : platelets
timeFrame: up to 15 days
measure: Safety: laboratories abnormalities : creatinine
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement
city: Ruse
country: Bulgaria
facility: Complex Oncological Center - Ruse Ltd, COVID Departement
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology
city: Sofia
country: Bulgaria
facility: 5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens, Critical Care Departement
city: Athens
country: Greece
facility: "Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department
city: Thessaloniki
country: Greece
facility: "Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics
city: Cluj-napoca
country: Romania
facility: Leon Daniello Clinical Hospital of Pneumoftiziology
city: Craiova
country: Romania
facility: Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova
city: Otopeni
country: Romania
facility: Military Field Hospital ROL-2
city: Timisoara
country: Romania
facility: Pius Brinzeu County Emergency Clinical Hospital Timisoara
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
city: Majadahonda
country: Spain
facility: Puerta del Hierro University Hospital
city: Bağcılar
country: Turkey
facility: Bağcılar Medipol Mega Universite Hastanesi
city: Fatih
country: Turkey
facility: Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
Study officials:
References: