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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04928430
• Other study ID #: XT-2002
• Secondary ID: 2020-005979-12
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 28, 2021
• Est. completion date: November 28, 2022

Study information

• Verified date: January 2023
• Source: Xenothera SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 290
• Est. completion date: November 28, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• XAV-19
150 mg of XAV-19 single IV perfusion
• Placebo
Single IV infusion

Locations

Country	Name	City	State
Bulgaria	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	Complex Oncological Center - Ruse Ltd, COVID Departement	Ruse
Bulgaria	Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology	Ruse
Bulgaria	5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric	Sofia
Greece	"Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens	Athens
Greece	Evangelismos General Hospital of Athens, Critical Care Departement	Athens
Greece	University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit	Heraklion
Greece	"Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics	Thessaloniki
Greece	AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department	Thessaloniki
Romania	Leon Daniello Clinical Hospital of Pneumoftiziology	Cluj-napoca
Romania	Hospital for Infectious Diseases and Pneumology "Victor Babes" Craiova	Craiova
Romania	Military Field Hospital ROL-2	Otopeni
Romania	Pius Brinzeu County Emergency Clinical Hospital Timisoara	Timisoara
Spain	Ramón y Cajal University Hospital	Madrid
Spain	Puerta del Hierro University Hospital	Majadahonda
Turkey	Bagcilar Medipol Mega Universite Hastanesi	Bagcilar
Turkey	Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Xenothera SAS

Countries where clinical trial is conducted

Bulgaria,  Greece,  Romania,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Clinical parameters : body temperature	°C	Between randomization and Day 3, 5, 8 and 15
Secondary	Change in Clinical parameters : Respiratory rate	breath/min	Between randomization and Day 3, 5, 8 and 15
Secondary	Change in Clinical parameters : SpO2 at ambiant air		Between randomization and Day 3, 5, 8 and 15
Secondary	Change in Clinical parameters : Supplemental O2	L/min	Between randomization and Day 3, 5, 8 and 15
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay		up to 15 days
Secondary	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
Secondary	Proportion of patients referred to Intensive Care Unit (ICU)		Between randomization and Day 3, 5, 8 and 15
Secondary	Proportion of patients with need for mechanical ventilation		At randomization and at Day 3, 5, 8 and 15
Secondary	Survival rates		at day 8 and day 15 after randomization
Secondary	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
Secondary	Safety: hypersensitivity or allergy	Incidence of hypersensitivity reactions and allergy	up to 15 days
Secondary	Safety: laboratories abnormalities : white blood cell count	G/L	up to 15 days
Secondary	Safety: laboratories abnormalities : red blood cell count	10 12/L	up to 15 days
Secondary	Safety: laboratories abnormalities : hemoglobin	g/dL	up to 15 days
Secondary	Safety: laboratories abnormalities : platelets	G/L	up to 15 days
Secondary	Safety: laboratories abnormalities : creatinine	µmol/L	up to 15 days