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

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.

Timeline

Start

2020-05-12

Primary completion

2022-01-01

Completion

2022-01-01

Publications

• Sgalla G, Leone PM, Gualano G, Simonetti J, Comes A, Verdirosi D, Di Gennaro F, Larici AR, Ianniello S, Cicchetti G, Fusco N, Pani M, Palmieri F, Richeldi L. A randomized trial of pamrevlumab in patients with COVID-19 pneumonia. Respirology. 2023 Oct;28(10):954-957. doi: 10.1111/resp.14575. Epub 2023 Aug 21. No abstract available.

Drugs

Indications