NCT04659109.

Methods	Trial design: randomised, double‐blind, multicentre, placebo‐controlled, parallel‐group, fixed‐dose, phase II study Type of publication: trial registration Setting: hospital Recruitment dates: completed Country: France Language: English Number of centres: NR Inclusion criteria: male or female hospitalised patients ≥ 18 years; having given their written consent; having a positive RT‐PCR test for COVID‐19; 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, presenting with signs of moderate but progressive pulmonary disease (with: respiratory symptoms (cough, dyspnoea, 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 48 hours); 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; women of child‐bearing potential must have negative results of a urinary or plasma pregnancy test (serum HCG). Exclusion criteria: patients requiring immediate admission to the ICU; patients requiring invasive mechanical ventilation, acute respiratory distress syndrome (ARDS) of another origin; concomitant pulmonary infection (pneumoniae) with another agent, notably bacterial or fungal; patients under immunosuppressive agents; childbirth within < 10 days; pregnancy or breastfeeding; prior cardiopulmonary resuscitation < 10 days; allergy or hypersensitivity to drugs of the same class; participation in another interventional clinical trial within 30 days prior to the inclusion. Trial registration number: NCT04659109 Date of trial registration: 9 December 2020
Participants	Age: ≥ 18 years Gender: male and female Ethnicity: NR Number of participants (recruited/allocated/evaluated): NR, but 60 planned Severity of disease: hospitalised participants WHO Clinical Progression Scale 4‐5 Additional diagnoses: NR Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR Percentage of positive PCR: 100% (due to inclusion criteria)
Interventions	Intervention (e.g dose, route of administration): 1000 mg glenzocimab per day for 3 days, IV Control: placebo, IV Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: 40 days planned Treatment cross‐overs: NR Compliance with assigned treatment: NR
Outcomes	Primary outcome: progression from moderate to severe assessed at day 4 is a composite failure endpoint, defined as the occurrence of at least one of the following failure events: respiratory rate (RR) ≥ 30/min, or oxygen saturation (SpO2) ≤ 93% in resting state, or oxygen pressure/ inspired fraction (PaO2/FiO2) ≤ 200 mmHg, death occurring prior to or on day 4 Secondary outcomes, assessed up to day 40 unless otherwise specified All‐cause mortality WHO‐COVID‐19 scale NEWS‐2 scale Respiratory rate status (RR) Hypoxaemia status SpO2 status CHEST CT‐Scan (or in exceptional cases, chest radiogram) Oxygen‐free days Admission to the ICU ICU‐free days Hospital‐free days Clinical recovery and time to clinical recovery Cure and time to cure Incidence, nature and severity of adverse events, serious adverse events (SAEs), suspected unexpected serious adverse reaction (SUSARs) and Treatment‐Emergent Adverse Events (TEAEs) Incidence of bleeding‐related events Incidence of hypersensitivity reactions Changes from baseline on blood pressure Changes from baseline on heart rate Changes from baseline on neuroforaminal stenosis Changes from baseline on INR (international normalised ratio)/PTT (prothrombin time test) Other biochemical markers not of interest to our review
Notes	Sponsor/funding: Acticor Biotech First posted: 9 December 2020 Last update posted: 13 September 2021