SARS VirusPhase 2POLYCORNCT04453384
Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
A Phase 2 study testing XAV-19 in people with SARS Virus, run by Nantes University Hospital at 34 sites in 3 countries.
Trial summary
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS Virus
- What is being tested?
- XAV-19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 1 Sep 2020to 19 Aug 2021
- Phase
- Phase 2
- 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
- Willing and able to provide written informed consent prior to performing study procedures
- Male or female ≥ 18 years and ≤ 85 years
- Hospitalized for COVID-19
- Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum) ≤ 10 days before enrolment
- Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or chest-imaging [Chest X-ray or computed tomography])
- Requiring O2 supplement ≤ 6L/min at screening
Show all 23Show fewer
- Requiring O2 supplementation with SpO2 ≥ 94% on O2 therapy at screening
- First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, whichever as occurred fist
- WOCBP must have a negative urinary pregnancy test the day of inclusion
- All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of XAV-19, whichever is longer
- Patients with French social security
- Willing and able to provide written informed consent prior to performing study procedures
- Male or female ≥ 18 years
- Hospitalized for COVID-19
- Documentation of SARS-Cov-2 infection before enrolment, by positive SARS-CoV-2 RT-PCR or antigen in any body specimen (nasopharynx, oropharynx, saliva, sputum, bronchoalveolar lavage …) before enrolment
- Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or chestimaging [Chest X-ray or computed tomography])
- Requiring O2 supplement ≤ 6L/min at screening
- Requiring O2 supplementation with SpO2 ≥ 92% on O2 therapy at screening (or ≥ 90
- % if chronic obstructive pulmonary disease)
- First onset of COVID-19 symptoms ≤ 14 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, whichever as occurred fist (other symptoms such as asthenia not to be considered in this list)
- WOCBP must have a negative urinary pregnancy test the day of inclusion
- All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of XAV-19, whichever is longer
- Patients with French social security
Who cannot join
- Evidence of multiorgan failure (severe COVID-19)
- Mechanically ventilated (including ECMO)
- Receipt of immunoglobulins or any blood products in the past 30 days
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the investigator, would affect subject safety and/or compliance
- End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
- Child-Pugh C stage liver cirrhosis
Show all 32Show fewer
- Decompensated cardiac insufficiency
- History of active drug abuse
- Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
- Females of childbearing potential without contraceptive method, or with positive pregnancy test, breastfeeding, or planning to become pregnant during the study period
- Current documented and uncontrolled bacterial infection.
- Prior severe (grade 3) allergic reactions to plasma transfusion
- Patient participating in another interventional clinical trial
- Life expectancy estimated to be less than 6 months
- Patient under guardianship or trusteeship
- Phase 2b:
- Evidence of multiorgan failure (severe COVID-19)
- Mechanically ventilated (including ECMO)
- Receipt of immunoglobulins or any blood products in the past 30 days
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the investigator, would affect subject safety and/or compliance
- End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
- Child-Pugh C stage liver cirrhosis
- Decompensated cardiac insufficiency
- Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components
- Females of childbearing potential without contraceptive method, or with positive pregnancy test, breastfeeding, or planning to become pregnant during the study period
- Current documented and uncontrolled bacterial infection.
- Prior severe (grade 3) allergic reactions to plasma transfusion
- Patient participating in another interventional clinical trial
- Life expectancy estimated to be less than 6 months
- Patient under guardianship or trusteeship
- Patient already included
- Prior hospitalisation in intensive care unit for the current covid-19 episode
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
France32 sites
CHU Amiens Picardie
Amiens
CHU Angers
Angers
Hôpital Privé d'Antony
Antony
CH Avignon
Avignon
CH de la Côte Basque
Bayonne
APHP - Hôpital Avicennes
Bobigny
CHU Caen
Caen
CH Métropole Savoie
Chambéry
CH Colmar
Colmar
CH Sud Francilien
Corbeil-Essonnes
CHD Vendée
La Roche-sur-Yon
CH de La Rochelle
La Rochelle
CH Le Mans
Le Mans
CHRU Lille
Lille
CHU Limoges
Limoges
Hospices Civils Lyon
Lyon
CH de Mont de Marzan
Mont-de-Marsan
GHR Mulhouse Sud-Alsace
Mulhouse
CHU Nantes
Nantes
CHU Nice
Nice
CHU Nîmes
Nîmes
CHR Orléans La Source
Orléans
APHP - Hôpital Tenon
Paris
Hôpital Saint Antoine
Paris
CH René Dubos
Pontoise
CH Cornouaille
Quimper
CHU Reims
Reims
CHU Saint Etienne
Saint-Priest-en-Jarez
CHU Strasbourg
Strasbourg
Hôpital FOCH
Suresnes
CHRU Nancy
Vandœuvre-lès-Nancy
CH Bretagne Atlantique
Vannes
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 (2a and 2b) Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3.
Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients.
Read more
A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans.
The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.
Read the detailed description
For the first set of statistical analyses, to allow early reporting of primary and secondary endpoints at D15, the blind will be partially broken once all patients have completed Day 29. Except for statisticians, only the principal investigator and the scientific coordinator will have access to the full data set for the analysis of the primary and secondary endpoints up to day 29. The database will be partially locked (with all data up to day 29) as neither monitors nor investigators will be informed of the unblinding until the final data for day 60 is completed and the final database is locked.
- Conditions
- SARS Virus
- Being tested
- XAV-19, Placebo
- Keywords
- SARS-Cov-2, COVID-19, Moderate, pneumonia, antibody
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Lymphoma, Follicular, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XAV-19Drug
Phase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1
PlaceboDrug
Phase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Administrations of XAV-19
* Phase 2a: XAV-19 at 0.5 mg/kg at D1 and D5(Group 1) or at 2 mg/kg at D1 and D5 (Group 2), or at 2 mg/kg at D1 (groupe 3)
* Phase 2b: Selected dose from Phase 2a : one administration at 2 mg/kg on day1 Receives: Drug: XAV-19 |
| Placebo arm | Placebo comparator | same administration as treatment arm
* Phase 2a: two administrations of placebo (day 1 and day 5) for Group 1 and 2, one administration of placebo on day 1 for Group 3
* Phase 2b: one administration of placebo on day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2a: XAV-19 antibody titers
The primary endpoint is measurement of the antibody titer XAV-19 in all treated patients and in all patients in the placebo group at Day 8
Measured: Day 8
Phase 2a: Adverse events of XAV-19
Adverse events of XAV-19 between the two groups of treated patients and vs. placebo over 29 days
Measured: Day 29
Phase 2b: To evaluate the efficacy of XAV-19 + standard-of-care (Soc) therapy compared with placebo + Soc therapy for treatment of COVID-19 assessed by the proportion of patients who die or develop respiratory failure between baseline and Day 15.
Efficacy is defined by the proportion of patients who died or develop respiratory failure, as defined by the requirement of noninvasive ventilation, high-flow oxygen devices, invasive mechanical ventilation (corresponding to a score of 5 or more on the WHO 8 point ordinal scale) or by an increase of the required O2 supplement (more or equals to 10 L/minutes with a non-rebreather mask (oxygen mask with reservoir bag)
Measured: Day 15
Secondary outcomes (27)
Phase 2a: Pharmacokinetic analysis
XAV-19 Antibody titer over the time
Measured: Day 1 (pre-dose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day 29
Phase 2a: Antibody titer between the two groups
The antibody titer of XAV-19 measurements in Group 1 treated patients and Group 2 treated patients
Measured: day 15
Phase 2a: Supplemental oxygen
Duration of supplemental oxygen
Measured: Day 1 to Day 29
Phase 2a: Evaluation of Transfer to intensive care
Transfer to intensive care unit with need for invasive mechanical ventilation or high flow oxygen
Measured: Day 1 to Day 29
Phase 2a: Normalization of Fever
Normalization of fever ≥ 24 hours: clinical assessment every day from Day 1 to Day 14. Evaluation to be performed between 8 and 12 am, Day X evaluation will consider the higher value during Day X-1
Measured: Day 1 to Day 29
Phase 2a: Biomarkers
Biomarkers : CRP, Ferritin
Measured: Day 1 to Day 29
Phase 2a: Hospital length of stay
Evaluation of Hospital length of stay
Measured: Day 1 to Day 29
Phase 2b: Efficacy of XAV-19
Proportion of patients who die, develop respiratory failure, as defined by the requirement of noninvasive ventilation, high-flow oxygen devices or invasive mechanical ventilation at Day 8 and D29
Measured: Day 8 and Day 29
Phase 2b: Clinical severity
- National Early Warning Score (NEWS) assessed while hospitalized and on Day 15 and Day 29
Measured: Day 3, Day 5, Day 8, Day15 and Day 29
Phase 2b: Clinical severity
- Clinical status using the 8-point ordinal scale assessed daily until Day 29
Measured: Day 29
Phase 2b: Clinical severity : Improvement of clinical and biological parameters
- Temperature and blood analysis between baseline and Day 15, and Day 29
Measured: Day15, and Day 29
Phase 2b: Clinical severity : Oxygenation
- Days of oxygen therapy over 29 days PaO2 / FiO2 at baseline, Day 5, Day 8, Day 15, Day 29 if available
Measured: 29 Days
Phase 2b: Clinical severity : Non-invasive ventilation, high-flow oxygen
- e) Days of non-invasive ventilation or high flow oxygen (if applicable) up to Day 29
Measured: 29 Days
Phase 2b: Clinical severity : Invasive mechanical ventilation / Extra Corporeal Membrane Oxygenation (ECMO)
- Days of invasive mechanical ventilation/ECMO (if applicable) up to Day 29
Measured: 29 Days
Phase 2b: Clinical severity : Transfer in ICU by Day 29
- Transfer in ICU
Measured: 29 Days
Phase 2b: Clinical severity : Hospitalization
- Hospital length of stay (in days)
Measured: 60 Days
Phase 2b: Clinical severity : Mortality
- All-cause mortality evaluated between baseline and Day 15 and between baseline and at Day 29 and at Day 60
Measured: 60 Days
Phase 2b: Clinical severity : Thrombotic events
- Thrombotic events (peripheral venous, pulmonary, arterial)
Measured: 60 Days
Phase 2b: mortality
- All cause mortality
Measured: 29 Days
Phase 2b: safety
Occurrence of all suspected XAV-19 related adverse effects or Incidence of serious adverse events
Measured: 29 days and 60 days
Phase 2b: safety of Study drug infusion
Study drug discontinuation or temporary suspension of infusion
Measured: 29 days and 60 days
Phase 2b: safety : study drug discontinuation
Proportion of participants with treatment emergent adverse events leading to study drug discontinuation
Measured: 29 days and 60 days
Phase 2b: safety : major or opportunistic bacterial or fungal infections
Incidence of major or opportunistic bacterial or fungal infections
Measured: 29 days and 60 days
Phase 2b: safety : hypersensitivity reactions and infusion reactions
Incidence of hypersensitivity reactions and infusion reactions
Measured: 29 days and 60 days
Phase 2b: safety : biological parameters
White cell count, hemoglobin, platelets, creatinine, ALT, AST, on D1, D3, D5, D8, D15 and D29
Measured: 29 days and 60 days
Phase 2b: Exploratory analysis : qualitative and quantitative SARS-CoV-2 status
SARS-CoV-2 status (positive or negative and quantitatively, including variant information by sequencing) over time (D1, D8, D15, and D29)
Measured: Day 1, Day 8, Day 15 and Day 29
Phase 2b: Exploratory analysis : SARS-CoV-2 status viral load
SARS-CoV-2 status viral load over time (D1, D8, D15, and D29)
Measured: Day 1, Day 8, Day 15 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Sep 2020
- Primary completion21 May 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS VirusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BPIfrance, Xenothera SAS
- Responsible party
- Sponsor
- Investigators
- Benjamin Gaborit, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453384
- Sponsor's protocol ID
- RC20_0230
- Acronym
- POLYCOR
- Status last verified
- Mar 2022
- First submitted
- 22 Jun 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimber C, Valk SJ, Chai KL, Piechotta V, Iannizzi C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Hyperimmune immunoglobulin for people with COVID-19. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD015167. doi: 10.1002/14651858.CD015167.pub2.
PubMed 36700518Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343Gaborit B, Dailly E, Vanhove B, Josien R, Lacombe K, Dubee V, Ferre V, Brouard S, Ader F, Vibet MA, Le Thuaut A, Danger R, Flet L, Omnes A, Berly L, Chiffoleau A, Jobert A, Duvaux O, Raffi F; POLYCOR Trial Group. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study. Antimicrob Agents Chemother. 2021 Aug 17;65(9):e0123721. doi: 10.1128/AAC.01237-21. Epub 2021 Aug 17.
PubMed 34181475Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, Lacombe K, Dubee V, Ader F, Ferre V, Vicaut E, Orain J, Le Bras M, Omnes A, Berly L, Jobert A, Morineau-Le Houssine P, Botturi K, Josien R, Flet L, Degauque N, Brouard S, Duvaux O, Poinas A, Raffi F; POLYCOR study group. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. Trials. 2021 Mar 9;22(1):199. doi: 10.1186/s13063-021-05132-9.
PubMed 33750432
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 2 (2a and 2b) Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
- ClinicalTrials.gov ID
- NCT04453384
- Acronym / sponsor ID
- POLYCOR / RC20_0230
- Conditions
- SARS Virus
- Keywords
- SARS-Cov-2, COVID-19, Moderate, pneumonia, antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- BPIfrance, Xenothera SAS
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3.
Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients.
A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans.
The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.
Detailed description
For the first set of statistical analyses, to allow early reporting of primary and secondary endpoints at D15, the blind will be partially broken once all patients have completed Day 29. Except for statisticians, only the principal investigator and the scientific coordinator will have access to the full data set for the analysis of the primary and secondary endpoints up to day 29. The database will be partially locked (with all data up to day 29) as neither monitors nor investigators will be informed of the unblinding until the final data for day 60 is completed and the final database is locked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: XAV-19Administrations of XAV-19 * Phase 2a: XAV-19 at 0.5 mg/kg at D1 and D5(Group 1) or at 2 mg/kg at D1 and D5 (Group 2), or at 2 mg/kg at D1 (groupe 3) * Phase 2b: Selected dose from Phase 2a : one administration at 2 mg/kg on day1 |
| Placebo arm | Placebo comparator | Drug: Placebosame administration as treatment arm * Phase 2a: two administrations of placebo (day 1 and day 5) for Group 1 and 2, one administration of placebo on day 1 for Group 3 * Phase 2b: one administration of placebo on day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Willing and able to provide written informed consent prior to performing study procedures
- Male or female ≥ 18 years and ≤ 85 years
- Hospitalized for COVID-19
- Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum) ≤ 10 days before enrolment
- Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or chest-imaging [Chest X-ray or computed tomography])
Key exclusion criteria (32 listed)
- Evidence of multiorgan failure (severe COVID-19)
- Mechanically ventilated (including ECMO)
- Receipt of immunoglobulins or any blood products in the past 30 days
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the investigator, would affect subject safety and/or compliance
- End-stage renal disease (eGFR < 15 ml/min/1,73 m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XAV-19Phase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1 | Drug | Treatment arm |
| PlaceboPhase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1 | Drug | Placebo arm |
Primary outcome
Phase 2a: XAV-19 antibody titers
Time frame: Day 8
The primary endpoint is measurement of the antibody titer XAV-19 in all treated patients and in all patients in the placebo group at Day 8
Phase 2a: Adverse events of XAV-19
Time frame: Day 29
Adverse events of XAV-19 between the two groups of treated patients and vs. placebo over 29 days
Phase 2b: To evaluate the efficacy of XAV-19 + standard-of-care (Soc) therapy compared with placebo + Soc therapy for treatment of COVID-19 assessed by the proportion of patients who die or develop respiratory failure between baseline and Day 15.
Time frame: Day 15
Efficacy is defined by the proportion of patients who died or develop respiratory failure, as defined by the requirement of noninvasive ventilation, high-flow oxygen devices, invasive mechanical ventilation (corresponding to a score of 5 or more on the WHO 8 point ordinal scale) or by an increase of the required O2 supplement (more or equals to 10 L/minutes with a non-rebreather mask (oxygen mask with reservoir bag)
27 secondary outcomes
Phase 2a: Pharmacokinetic analysis
Time frame: Day 1 (pre-dose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day 29
Phase 2a: Antibody titer between the two groups
Time frame: day 15
Phase 2a: Supplemental oxygen
Time frame: Day 1 to Day 29
Phase 2a: Evaluation of Transfer to intensive care
Time frame: Day 1 to Day 29
Phase 2a: Normalization of Fever
Time frame: Day 1 to Day 29
Phase 2a: Biomarkers
Time frame: Day 1 to Day 29
Phase 2a: Hospital length of stay
Time frame: Day 1 to Day 29
Phase 2b: Efficacy of XAV-19
Time frame: Day 8 and Day 29
Phase 2b: Clinical severity
Time frame: Day 3, Day 5, Day 8, Day15 and Day 29
Phase 2b: Clinical severity
Time frame: Day 29
Phase 2b: Clinical severity : Improvement of clinical and biological parameters
Time frame: Day15, and Day 29
Phase 2b: Clinical severity : Oxygenation
Time frame: 29 Days
Phase 2b: Clinical severity : Non-invasive ventilation, high-flow oxygen
Time frame: 29 Days
Phase 2b: Clinical severity : Invasive mechanical ventilation / Extra Corporeal Membrane Oxygenation (ECMO)
Time frame: 29 Days
Phase 2b: Clinical severity : Transfer in ICU by Day 29
Time frame: 29 Days
Phase 2b: Clinical severity : Hospitalization
Time frame: 60 Days
Phase 2b: Clinical severity : Mortality
Time frame: 60 Days
Phase 2b: Clinical severity : Thrombotic events
Time frame: 60 Days
Phase 2b: mortality
Time frame: 29 Days
Phase 2b: safety
Time frame: 29 days and 60 days
Phase 2b: safety of Study drug infusion
Time frame: 29 days and 60 days
Phase 2b: safety : study drug discontinuation
Time frame: 29 days and 60 days
Phase 2b: safety : major or opportunistic bacterial or fungal infections
Time frame: 29 days and 60 days
Phase 2b: safety : hypersensitivity reactions and infusion reactions
Time frame: 29 days and 60 days
Phase 2b: safety : biological parameters
Time frame: 29 days and 60 days
Phase 2b: Exploratory analysis : qualitative and quantitative SARS-CoV-2 status
Time frame: Day 1, Day 8, Day 15 and Day 29
Phase 2b: Exploratory analysis : SARS-CoV-2 status viral load
Time frame: Day 1, Day 8, Day 15 and Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 36700518Kimber C, Valk SJ, Chai KL, Piechotta V, Iannizzi C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Hyperimmune immunoglobulin for people with COVID-19. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD015167. doi: 10.1002/14651858.CD015167.pub2.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Derived from this study: PubMed 34181475Gaborit B, Dailly E, Vanhove B, Josien R, Lacombe K, Dubee V, Ferre V, Brouard S, Ader F, Vibet MA, Le Thuaut A, Danger R, Flet L, Omnes A, Berly L, Chiffoleau A, Jobert A, Duvaux O, Raffi F; POLYCOR Trial Group. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study. Antimicrob Agents Chemother. 2021 Aug 17;65(9):e0123721. doi: 10.1128/AAC.01237-21. Epub 2021 Aug 17.
- Derived from this study: PubMed 33750432Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, Lacombe K, Dubee V, Ader F, Ferre V, Vicaut E, Orain J, Le Bras M, Omnes A, Berly L, Jobert A, Morineau-Le Houssine P, Botturi K, Josien R, Flet L, Degauque N, Brouard S, Duvaux O, Poinas A, Raffi F; POLYCOR study group. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. Trials. 2021 Mar 9;22(1):199. doi: 10.1186/s13063-021-05132-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Gaborit principal investigator
Nantes University Hospital
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XAV-19 in people with SARS Virus, run by Nantes University Hospital at 34 sites in 3 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 23 inclusion and 32 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: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Martinique, Reunion. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase 2a: XAV-19 antibody titers (time frame: Day 8). The study lists 3 primary outcomes in all. 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 NCT04453384, which also lists 4 linked publications.
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 25 Mar 2022.