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COVID-19Phase 2/3NCT04928430

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

A Phase 2/3 study testing XAV-19 in people with COVID-19, run by Xenothera SAS at 18 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
XAV-19
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
18 sitesin 5 countries
Study dates
28 Apr 2021to 28 Nov 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

Bulgaria5 sites

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

    Dimitrovgrad, 6400

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

    Plovdiv, 4000

  • Complex Oncological Center - Ruse Ltd, COVID Departement

    Rousse, 7002

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

    Rousse, 7002

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

    Sofia, 1233

Other trials in Bulgaria

Greece5 sites

  • Evangelismos General Hospital of Athens, Critical Care Departement

    Athens, 10676

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

    Athens, 11527

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

    Heraklion, 71110

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

    Thessaloniki, 54621

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

    Thessaloniki, 54642

Other trials in Greece

Romania4 sites

  • Leon Daniello Clinical Hospital of Pneumoftiziology

    Cluj-Napoca, 400371

  • Hospital for Infectious Diseases and Pneumology "Victor Babeş" Craiova

    Craiova, 200515

  • Military Field Hospital ROL-2

    Otopeni, 075100

  • Pius Brinzeu County Emergency Clinical Hospital Timisoara

    Timișoara, 300723

Other trials in Romania

Spain2 sites

  • Ramón y Cajal University Hospital

    Madrid, 28034

  • Puerta del Hierro University Hospital

    Majadahonda, 28222

Other trials in Spain

Turkey (Türkiye)2 sites

  • Bağcılar Medipol Mega Universite Hastanesi

    Bağcılar, 34214

  • Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

    Fatih, 34098

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested
XAV-19, Placebo
Keywords
COVID-19, SARS-CoV-2, polyclonal IgG
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XAV-19Drug

    150 mg of XAV-19 single IV perfusion

  • PlaceboDrug

    Single IV infusion

Study groups in NCT04928430
Study groupRoleWhat they receive
XAV-19ExperimentalXAV-19
Receives: Drug: XAV-19
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within 8 days after treatment

Secondary outcomes (19)

  1. Change in Clinical parameters : body temperature

    °C

    Measured: Between randomization and Day 3, 5, 8 and 15

  2. Change in Clinical parameters : Respiratory rate

    breath/min

    Measured: Between randomization and Day 3, 5, 8 and 15

  3. Change in Clinical parameters : SpO2 at ambiant air

    Measured: Between randomization and Day 3, 5, 8 and 15

  4. Change in Clinical parameters : Supplemental O2

    L/min

    Measured: Between randomization and Day 3, 5, 8 and 15

  5. 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)

    Measured: Between randomization and Day 3, 5, 8 and 15

  6. 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.

    Measured: up to 15 days

  7. Duration of aggravation

    Duration of aggravation will be defined as the time in days between start date of aggravation and improvement date.

    Measured: up to 15 days

  8. Length of hospital stay

    Measured: up to 15 days

  9. Viral status: RT-PCR or RT-qPCR for SARS-CoV-2

    (positive/negative)

    Measured: At randomization and on Day 8 or at the end of follow-up, whichever comes first

  10. Proportion of patients referred to Intensive Care Unit (ICU)

    Measured: Between randomization and Day 3, 5, 8 and 15

  11. Proportion of patients with need for mechanical ventilation

    Measured: At randomization and at Day 3, 5, 8 and 15

  12. Survival rates

    Measured: at day 8 and day 15 after randomization

  13. 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

    Measured: up to 15 days

  14. Safety: hypersensitivity or allergy

    Incidence of hypersensitivity reactions and allergy

    Measured: up to 15 days

  15. Safety: laboratories abnormalities : white blood cell count

    G/L

    Measured: up to 15 days

  16. Safety: laboratories abnormalities : red blood cell count

    10 12/L

    Measured: up to 15 days

  17. Safety: laboratories abnormalities : hemoglobin

    g/dL

    Measured: up to 15 days

  18. Safety: laboratories abnormalities : platelets

    G/L

    Measured: up to 15 days

  19. Safety: laboratories abnormalities : creatinine

    µmol/L

    Measured: up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start28 Apr 2021
  3. Primary completion28 Nov 2022
  4. Study completion28 Nov 2022

Why it stopped: Lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928430
Sponsor's protocol ID
XT-2002
Other IDs
2020-005979-12
Status last verified
Jan 2023
First submitted
27 May 2021
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38694503

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing XAV-19 in people with COVID-19, run by Xenothera SAS at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Bulgaria, Greece, Romania, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with an aggravation of COVID-19 (time frame: within 8 days after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04928430, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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