This is a randomized, open-label, parallel-arm study to investigate the efficacy and safety of pamrevlumab in patients with documented SARS-CoV-2 infection. The study consists of screening, a treatment period, and a follow-up period. The study will enroll patients who have been hospitalized and who are not currently on invasive mechanical ventilation. The treatment period is open ended, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a pre-generated randomization list. Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14. Based on Investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks. A follow-up by visit or phone call will be performed 8 and 12 weeks after the end of the last dose of treatment. The treatment period for an individual patient will not exceed 11 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14. Based on Investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks.
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Roma, Italy
Proportion of patients not on ventilatory support
Time frame: 15 days
PaO2/FiO2 ratio as categorical variable
Time frame: Day14
For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.
Time frame: up to 12 weeks
For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation
Time frame: up to 12 weeks
PaO2/FiO2 ratio as continuous variable
Time frame: Day14
Resting SpO2 adjusted by FiO2
Time frame: Day14
Change in oxygen supplementation requirements (liters per minute)
Time frame: Day14
Quantitative and qualitative assessment of pulmonary lesions by chest HRCT scans at baseline and at day 14 and week 12
Time frame: Day 14 and week 12
Time to hospital discharge
Time frame: up to 12 weeks
Time to all-cause mortality
Time frame: up to 28 days
Proportion of patients discharged from ICU and alive
Time frame: within 28 days
Proportion of patients alive
Time frame: within 28 days
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