Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19

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

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 Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: XAV-19; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement
  • Plovdiv, Bulgaria, 4000
    • University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement
  • Ruse, Bulgaria, 7002
    • Complex Oncological Center - Ruse Ltd, COVID Departement
  • Ruse, Bulgaria, 7002
    • Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology
  • Sofia, Bulgaria, 1233
    • 5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric
• Greece
  • Athens, Greece, 10676
    • Evangelismos General Hospital of Athens, Critical Care Departement
  • Athens, Greece, 11527
    • "Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens
  • Heraklion, Greece, 71110
    • University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit
  • Thessaloniki, Greece, 54621
    • AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department
  • Thessaloniki, Greece, 54642
    • "Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics
• Romania
  • Cluj-napoca, Romania, 400371
    • Leon Daniello Clinical Hospital of Pneumoftiziology
  • Craiova, Romania, 200515
    • Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova
  • Otopeni, Romania, 075100
    • Military Field Hospital ROL-2
  • Timisoara, Romania, 300723
    • Pius Brinzeu County Emergency Clinical Hospital Timisoara
• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal University Hospital
  • Majadahonda, Spain, 28222
    • Puerta del Hierro University Hospital
• Turkey
  • Bağcılar, Turkey, 34214
    • Bağcılar Medipol Mega Universite Hastanesi
  • Fatih, Turkey, 34098
    • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single IV infusion
Experimental: XAV-19	Drug: XAV-19; 150 mg of XAV-19 single IV perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 8 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical parameters : body temperature	°C	Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : Respiratory rate	breath/min	Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : SpO2 at ambiant air		Between randomization and Day 3, 5, 8 and 15
Change in Clinical parameters : Supplemental O2	L/min	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)	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.	up to 15 days
Duration of aggravation	Duration of aggravation will be defined as the time in days between start date of aggravation and improvement date.	up to 15 days
Length of hospital stay		up to 15 days
Viral status: RT-PCR or RT-qPCR for SARS-CoV-2	(positive/negative)	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)		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	Number and Proportion of participants with AE, SAE and treatment emergent adverse events leading to study drug discontinuation, to concomitant or additional treatment	up to 15 days
Safety: hypersensitivity or allergy	Incidence of hypersensitivity reactions and allergy	up to 15 days
Safety: laboratories abnormalities : white blood cell count	G/L	up to 15 days
Safety: laboratories abnormalities : red blood cell count	10 12/L	up to 15 days
Safety: laboratories abnormalities : hemoglobin	g/dL	up to 15 days
Safety: laboratories abnormalities : platelets	G/L	up to 15 days
Safety: laboratories abnormalities : creatinine	µmol/L	up to 15 days

Collaborators and Investigators

• Sponsor: Xenothera SAS

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; polyclonal IgG
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: XT-2002; 2020-005979-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No