Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (POLYCOR)
SARS Virus
About this trial
This is an interventional treatment trial for SARS Virus focused on measuring SARS-Cov-2, COVID-19, Moderate, pneumonia, antibody
Eligibility Criteria
Phase 2a:
Inclusion Criteria:
- 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 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
- 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
Sites / Locations
- CHU Amiens Picardie
- CHU Angers
- Hôpital Privé d'Antony
- CH Avignon
- CH de la Côte Basque
- APHP - Hôpital Avicennes
- CHU Caen
- CH Métropole Savoie
- CH Colmar
- CH Sud Francilien
- CHD Vendée
- CH de La Rochelle
- CH Le Mans
- CHRU Lille
- CHU Limoges
- Hospices Civils Lyon
- CH de Mont de Marzan
- GHR Mulhouse Sud-Alsace
- CHU Nantes
- CHU Nice
- CHU Nîmes
- CHR Orléans La Source
- APHP - Hôpital Tenon
- Hôpital Saint Antoine
- CH René Dubos
- CH Cornouaille
- CHU Reims
- CHU Saint Etienne
- CHU Strasbourg
- Hôpital FOCH
- CHRU Nancy
- CH Bretagne Atlantique
- CHU Martinique
- CHU La Réunion
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment arm
Placebo arm
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
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