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Completed

NCT Number: NCT05262309

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

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.

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Key information

Conditions

COVID-19 Respiratory Infection COVID-19 COVID-19 Pneumonia Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pamrevlumab

Drug

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.

Primary outcomes

  1. Proportion of patients not on ventilatory support

    Time frame: 15 days

Secondary outcomes

  1. PaO2/FiO2 ratio as categorical variable

    Time frame: Day14

  2. For patients already on mechanical ventilator at time of randomization, the number of days on ventilator after randomization.

    Time frame: up to 12 weeks

  3. For patients not on mechanical ventilator at time of randomization, the number of days not requiring invasive mechanical ventilation

    Time frame: up to 12 weeks

  4. PaO2/FiO2 ratio as continuous variable

    Time frame: Day14

  5. Resting SpO2 adjusted by FiO2

    Time frame: Day14

  6. Change in oxygen supplementation requirements (liters per minute)

    Time frame: Day14

  7. Quantitative and qualitative assessment of pulmonary lesions by chest HRCT scans at baseline and at day 14 and week 12

    Time frame: Day 14 and week 12

  8. Time to hospital discharge

    Time frame: up to 12 weeks

  9. Time to all-cause mortality

    Time frame: up to 28 days

  10. Proportion of patients discharged from ICU and alive

    Time frame: within 28 days

  11. Proportion of patients alive

    Time frame: within 28 days

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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)

Acronym: FibroCov-01

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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