Clinical trial NCT05262309: An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19
Official title: An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19 (FibroCov-01 / FGCL-3019-IST-014)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19 Respiratory Infection
COVID-19 Pneumonia
Covid19
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Documented COVID-19 infection
* Age \>=18 to \<=80 years
* Interstitial pneumonia (findings of consolidation or ground glass opacities as assessed by chest HRCT)
* Respiratory distress, defined as PaO2/FiO2 ratio of \>=100 \<=300 mmHg, requiring supplemental oxygen and hospitalization

Exclusion Criteria:

* Invasive mechanical ventilation at screening
* Pregnancy
* Incapacity to express a valid informed consent
* Known hypersensitivity to monoclonal antibodies used as experimental drugs for any clinical indication

Primary outcomes:
measure: Proportion of patients not on ventilatory support
timeFrame: 15 days
Secondary outcomes:
measure: PaO2/FiO2 ratio as categorical variable
timeFrame: Day14
measure: For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.
timeFrame: up to 12 weeks
measure: For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation
timeFrame: up to 12 weeks
measure: PaO2/FiO2 ratio as continuous variable
timeFrame: Day14
measure: Resting SpO2 adjusted by FiO2
timeFrame: Day14
measure: Change in oxygen supplementation requirements (liters per minute)
timeFrame: Day14
measure: Quantitative and qualitative assessment of pulmonary lesions by chest HRCT scans at baseline and at day 14 and week 12
timeFrame: Day 14 and week 12
measure: Time to hospital discharge
timeFrame: up to 12 weeks
measure: Time to all-cause mortality
timeFrame: up to 28 days
measure: Proportion of patients discharged from ICU and alive
timeFrame: within 28 days
measure: Proportion of patients alive
timeFrame: within 28 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: Roma
Study officials:
References: