Efficacy of pamrevlumab, a connective tissue growth factor monoclonal antibody, in patients with SARS-COV-2 infection.

AN OPEN-LABEL, RANDOMIZED, PARALLEL-ARM STUDY INVESTIGATING THE EFFICACY AND SAFETY OF INTRAVENOUS ADMINISTRATION OF PAMREVLUMAB VERSUS STANDARD OF CARE IN PATIENTS WITH SARS-COV-2 INFECTION - FibroCov

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001472-14-IT

Enrollment

Registered

2020-04-03

Start date

2020-05-06

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with documented SARS-CoV-2 infection

Interventions

Product Name: Pamrevlumab Product Code: FG-3019 Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with documented SARS-CoV-2 infection, -Age >=20 to =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients on invasive mechanical ventilator for more than 2 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the effect of pamrevlumab on the efficiency of blood oxygenation in patients with SARS-CoV-2 infection requiring hospitalization;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability profile of pamrevlumab in patients with SARS-CoV-2 infection requiring hospitalization.;Primary end point(s): Change from baseline in PaO2/FiO2 ratio ;Timepoint(s) of evaluation of this end point: at day 5. (Day 1 is defined as the day of randomization which must also include administration of the first dose of pamrevlumab)	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the effect of pamrevlumab on the efficiency of blood oxygenation in patients with SARS-CoV-2 infection requiring hospitalization;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability profile of pamrevlumab in patients with SARS-CoV-2 infection requiring hospitalization.;Primary end point(s): Change from baseline in PaO2/FiO2 ratio ;Timepoint(s) of evaluation of this end point: at day 5. (Day 1 is defined as the day of randomization which must also include administration of the first dose of pamrevlumab)

—

Secondary

Measure	Time frame
Secondary end point(s): The key secondary endpoints are as follows: (1) for patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation (i.e., ventilator-free days) up to day 15. (2) for patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization. Additional secondary endpoint will be: -Time on ventilator after randomization. -Time to mechanical ventilation (for patients not on ventilator at randomization). -Change from baseline to day 5 in resting SpO2 adjusted by FiO2 -Change from baseline to day 5 in oxygen supplementation. -Change from baseline in chest high-resolution CT (HRCT) scan to day 14, week 12, and week 24 (subgroup of enrolled patients). -Time to hospital discharge. -Time to all-cause mortality.;Timepoint(s) of evaluation of this end point: (Section E.5.2)	—

Measure

Time frame

Secondary end point(s): The key secondary endpoints are as follows: (1) for patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation (i.e., ventilator-free days) up to day 15. (2) for patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization. Additional secondary endpoint will be: -Time on ventilator after randomization. -Time to mechanical ventilation (for patients not on ventilator at randomization). -Change from baseline to day 5 in resting SpO2 adjusted by FiO2 -Change from baseline to day 5 in oxygen supplementation. -Change from baseline in chest high-resolution CT (HRCT) scan to day 14, week 12, and week 24 (subgroup of enrolled patients). -Time to hospital discharge. -Time to all-cause mortality.;Timepoint(s) of evaluation of this end point: (Section E.5.2)

—

Countries

Italy

Contacts

Public ContactMal. Infettive App. Respiratorio

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

fabrizio.palmieri@inmi.it00390655170401

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026