Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
BPIfrance
Xenothera SAS
Conditions:
SARS Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
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 st...
Eligibility Criteria
Inclusion
- Phase 2a:
- 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
- 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
Exclusion
- 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
- 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:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2021
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT04453384
Start Date
September 1 2020
End Date
August 19 2021
Last Update
March 25 2022
Active Locations (34)
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1
CHU Amiens Picardie
Amiens, France
2
CHU Angers
Angers, France
3
Hôpital Privé d'Antony
Antony, France
4
CH Avignon
Avignon, France