Clinical trial: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (NCT04453384)

Eligibility criteria:
Phase 2a:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent prior to performing study
             procedures

          2. Male or female ≥ 18 years and ≤ 85 years

          3. Hospitalized for COVID-19

          4. Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum) ≤ 10
             days before enrolment

          5. Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or
             chest-imaging [Chest X-ray or computed tomography])

          6. Requiring O2 supplement ≤ 6L/min at screening

          7. Requiring O2 supplementation with SpO2 ≥ 94% on O2 therapy at screening

          8. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache,
             myalgias, cough, shortness of breath, whichever as occurred fist

          9. WOCBP must have a negative urinary pregnancy test the day of inclusion

         10. 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

         11. Patients with French social security

        Exclusion Criteria:

          1. Evidence of multiorgan failure (severe COVID-19)

          2. Mechanically ventilated (including ECMO)

          3. Receipt of immunoglobulins or any blood products in the past 30 days

          4. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
             of the investigator, would affect subject safety and/or compliance

          5. End-stage renal disease (eGFR < 15 ml/min/1,73 m2)

          6. Child-Pugh C stage liver cirrhosis

          7. Decompensated cardiac insufficiency

          8. History of active drug abuse

          9. Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its
             components

         10. Females of childbearing potential without contraceptive method, or with positive
             pregnancy test, breastfeeding, or planning to become pregnant during the study period

         11. Current documented and uncontrolled bacterial infection.

         12. Prior severe (grade 3) allergic reactions to plasma transfusion

         13. Patient participating in another interventional clinical trial

         14. Life expectancy estimated to be less than 6 months

         15. Patient under guardianship or trusteeship

        Phase 2b:

        Inclusion criteria:

          1. Willing and able to provide written informed consent prior to performing study
             procedures

          2. Male or female ≥ 18 years and ≤ 85 years

          3. Hospitalized for COVID-19

          4. Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum)

             ≤ 10 days before enrolment

          5. Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or
             chestimaging [Chest X-ray or computed tomography])

          6. Requiring O2 supplement ≤ 6L/min at screening

          7. Requiring O2 supplementation with SpO2 ≥ 92% on O2 therapy at screening (or ≥ 90

             % if chronic obstructive pulmonary disease)

          8. First onset of COVID-19 symptoms ≤ 10 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)

          9. WOCBP must have a negative urinary pregnancy test the day of inclusion

         10. 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

         11. Patients with French social security

        Exclusion criteria:

          1. Evidence of multiorgan failure (severe COVID-19)

          2. Mechanically ventilated (including ECMO)

          3. Receipt of immunoglobulins or any blood products in the past 30 days

          4. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion
             of the investigator, would affect subject safety and/or compliance

          5. End-stage renal disease (eGFR < 15 ml/min/1,73 m2)

          6. Child-Pugh C stage liver cirrhosis

          7. Decompensated cardiac insufficiency

          8. History of active drug abuse

          9. Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its
             components

         10. Females of childbearing potential without contraceptive method, or with positive
             pregnancy test, breastfeeding, or planning to become pregnant during the study period

         11. Current documented and uncontrolled bacterial infection.

         12. Prior severe (grade 3) allergic reactions to plasma transfusion

         13. Patient participating in another interventional clinical trial

         14. Life expectancy estimated to be less than 6 months

         15. Patient under guardianship or trusteeship
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction