Status:
COMPLETED
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
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
COVID-19 Respiratory Infection
COVID-19 Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05262309
Start Date
May 12 2020
End Date
January 1 2022
Last Update
March 2 2022
Active Locations (1)
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1
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Roma, Italy, 00168