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

NCT04928430 | Terminated Phase 2 DMC

• 2 other identifiers: XT-20022020-005979-12
• Study Type: interventional
• Target: 290
• Locations: 5 countries
• Sites: 18

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; polyclonal IgG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in Clinical parameters : body temperature

  Between randomization and Day 3, 5, 8 and 15

• Change in Clinical parameters : Respiratory rate

  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

  Between randomization and Day 3, 5, 8 and 15

• Change in severity on Common Terminology Criteria of Adverse Events (CTCAE) scale (version 5.0)

  Between randomization and Day 3, 5, 8 and 15

Study Arms (2)

XAV-19

EXPERIMENTAL

XAV-19

Drug: XAV-19

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XAV-19 DRUG

150 mg of XAV-19 single IV perfusion

XAV-19

Placebo DRUG

Single IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xenothera SAS: lead

Study Sites (18)

Multiprofile Hospital for Active Treatment " St. Ekaterina" - Dimitrovgrad - EOOD, COVID Departement

Dimitrovgrad, 6400, Bulgaria

Location

University Multiprofile Hospital for Active Treatment - Plovdiv - AD, COVID Departement

Plovdiv, 4000, Bulgaria

Location

Complex Oncological Center - Ruse Ltd, COVID Departement

Rousse, 7002, Bulgaria

Location

Specialized Hospital for Active Treatment for Pneumophtisiatrics Diseases Dr. Dimitar Gramatikov - Ruse - EOOD, Departement of Pneumology

Rousse, 7002, Bulgaria

Location

5th Multiprofile hospital for Active Treatment - Sofia - EAD, Departement of Pneumology and Phtisiatric

Sofia, 1233, Bulgaria

Location

Evangelismos General Hospital of Athens, Critical Care Departement

Athens, 10676, Greece

Location

"Sotiria" General Hospital of Chest Diseases of Athens, 3rd Department of Medicine of University of Athens

Athens, 11527, Greece

Location

University Hospital of Heraklion, Department of Internal Medicine & Infectious Diseases Unit

Heraklion, 71110, Greece

Location

AHEPA University General Hospital of Thessaloniki, Infectious Diseases Division of 1st Internal Medicine Department

Thessaloniki, 54621, Greece

Location

"Hippokration" General Hospital of Thessaloniki, 3rd Department of Pediatrics

Thessaloniki, 54642, Greece

Location

Leon Daniello Clinical Hospital of Pneumoftiziology

Cluj-Napoca, 400371, Romania

Location

Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova

Craiova, 200515, Romania

Location

Military Field Hospital ROL-2

Otopeni, 075100, Romania

Location

Pius Brinzeu County Emergency Clinical Hospital Timisoara

Timișoara, 300723, Romania

Location

Ramón y Cajal University Hospital

Madrid, 28034, Spain

Location

Puerta del Hierro University Hospital

Majadahonda, 28222, Spain

Location

Bağcılar Medipol Mega Universite Hastanesi

Bağcılar, 34214, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (1)

• Poulakou G, Royer PJ, Evgeniev N, Evanno G, Shneiker F, Marcelin AG, Vanhove B, Duvaux O, Marot S, Calvez V. Anti-SARS-CoV-2 glyco-humanized polyclonal antibody XAV-19: phase II/III randomized placebo-controlled trial shows acceleration to recovery for mild to moderate patients with COVID-19. Front Immunol. 2024 Apr 17;15:1330178. doi: 10.3389/fimmu.2024.1330178. eCollection 2024.

  PMID: 38694503 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

XAV-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 16, 2021
• Study Start: April 28, 2021
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

BU (5); GR (5); RO (4); ES (2); TU (2)