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

Phase 2

Completed

• Conditions: COVID-19 Respiratory Infection; COVID-19 Pneumonia; Covid19
• Interventions: Drug: Pamrevlumab

• Registration Number: NCT05262309
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Status Verified: 2021-06
• Study First Submitted: 2021-06-07
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Study First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pamrevlumab	Pamrevlumab	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients not on ventilatory support	15 days

Secondary Outcome Measures

Name	Time	Method
Proportion of patients alive	within 28 days
PaO2/FiO2 ratio as categorical variable	Day14
For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.	up to 12 weeks
PaO2/FiO2 ratio as continuous variable	Day14
Change in oxygen supplementation requirements (liters per minute)	Day14
Quantitative and qualitative assessment of pulmonary lesions by chest HRCT scans at baseline and at day 14 and week 12	Day 14 and week 12
Time to all-cause mortality	up to 28 days
Resting SpO2 adjusted by FiO2	Day14
Proportion of patients discharged from ICU and alive	within 28 days
Time to hospital discharge	up to 12 weeks
For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation	up to 12 weeks

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS; 🇮🇹 Rome, Roma, Italy