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

Covid19 Clinical Trial

— FibroCov-01  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262309
• Other study ID #: 3135
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 12, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: June 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients not on ventilatory support		15 days
Secondary	PaO2/FiO2 ratio as categorical variable		Day14
Secondary	For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.		up to 12 weeks
Secondary	For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation		up to 12 weeks
Secondary	PaO2/FiO2 ratio as continuous variable		Day14
Secondary	Resting SpO2 adjusted by FiO2		Day14
Secondary	Change in oxygen supplementation requirements (liters per minute)		Day14
Secondary	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
Secondary	Time to hospital discharge		up to 12 weeks
Secondary	Time to all-cause mortality		up to 28 days
Secondary	Proportion of patients discharged from ICU and alive		within 28 days
Secondary	Proportion of patients alive		within 28 days