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

NCT ID: NCT05262309

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2022-01-01

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.

Conditions

COVID-19 Respiratory Infection; COVID-19 Pneumonia; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pamrevlumab

Group Type: EXPERIMENTAL

Pamrevlumab

Intervention Type: DRUG

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.

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37605035 (View on PubMed)

Other Identifiers

3135

Identifier Type: -

Identifier Source: org_study_id