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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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COVID-19 Respiratory Infection, COVID-19 Pneumonia, Covid19

Intervention / Treatment
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* Drug: Pamrevlumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pamrevlumab<br> | Drug: Pamrevlumab<br>* 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.<br>|
| No Intervention: Standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients not on ventilatory support |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation |  | up to 12 weeks | 
| PaO2/FiO2 ratio as continuous variable |  | Day14 | 
| Resting SpO2 adjusted by FiO2 |  | 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 hospital discharge |  | up to 12 weeks | 
| Time to all-cause mortality |  | up to 28 days | 
| Proportion of patients discharged from ICU and alive |  | within 28 days | 
| Proportion of patients alive |  | within 28 days |