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)

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Drug: Pamrevlumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05262309

3135

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Pamrevlumab

Experimental group

Treatment:

Drug: Pamrevlumab

Standard of care

No Intervention group