Clinical trial: Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19 (NCT04659109)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female hospitalized patients ≥ 18 years (i.e., at least 18 years old at the
             time of randomization), having given their written consent.

          2. Having a positive RT-PCR test for COVID-19

          3. Presenting with symptoms of COVID-19, including:

               -  Cough OR

               -  Shortness of breath or difficulty breathing OR at least 2 of the following

               -  Fever, defined as any body temperature 38°C

               -  Chills

               -  Repeated shaking with chills

               -  Muscle pain

               -  Headache

               -  Sore throat

               -  New loss of taste or smell

          4. Presenting with signs of moderate but progressive pulmonary disease with:

               -  respiratory symptoms (cough, dyspnea, etc.),

               -  uni- or bilateral ground-glass opacities, or pulmonary infiltrates on chest
                  radiograph and/or CT scan,

               -  clinical and biological evidence of progression over the past 48hrs.

          5. Effective birth control that should have been in place for at least 2 months in
             non-menopausal women and 4 months for men after IMP administration. Birth control
             methods considered to be highly effective include:

               -  combined (estrogen-progestogen) hormonal contraception associated with the
                  inhibition of ovulation: oral, intravaginal, transdermal,

               -  progesterone-only hormonal contraception associated with the inhibition of
                  ovulation: oral, injectable, implantable,

               -  intrauterine device,

               -  intrauterine hormone-releasing system,

               -  bilateral tubal occlusion,

               -  vasectomized partner.

          6. Women of child-bearing potential must have negative results of a urinary or plasma
             pregnancy test (serum HCG).

        Exclusion Criteria:

          1. Patients requiring immediate admission to the ICU,

          2. Patients requiring invasive mechanical ventilation,

          3. ARDS of another origin,

          4. Concomitant pulmonary infection (pneumoniae) with another agent, notably bacterial or
             fungal,

          5. Patients under immunosuppressive agents,

          6. Childbirth within <10 days,

          7. Pregnancy or breastfeeding,

          8. Prior cardiopulmonary resuscitation <10 days,

          9. Allergy or hypersensitivity to drugs of the same class

         10. Participation in another interventional clinical trial within 30 days prior to the
             inclusion.
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 80 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? 0