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

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Respiratory Infection
• COVID-19 Pneumonia
• Covid19

Interventions

Type	Name	Description
DRUG	Pamrevlumab	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.

Timeline

• Start date: 2020-05-12
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2022-03-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: Italy