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

NCT05262309 | Completed Phase 2

• 1 other identifier: 3135
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19 Respiratory Infection; COVID-19 Pneumonia; Covid19

Outcome Measures

Primary Outcomes (1)

• Proportion of patients not on ventilatory support

  15 days

Secondary Outcomes (11)

• 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

Study Arms (2)

Pamrevlumab

EXPERIMENTAL

Drug: Pamrevlumab

Standard of care

NO INTERVENTION

Interventions

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.

Pamrevlumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

Related Publications (1)

• Sgalla G, Leone PM, Gualano G, Simonetti J, Comes A, Verdirosi D, Di Gennaro F, Larici AR, Ianniello S, Cicchetti G, Fusco N, Pani M, Palmieri F, Richeldi L. A randomized trial of pamrevlumab in patients with COVID-19 pneumonia. Respirology. 2023 Oct;28(10):954-957. doi: 10.1111/resp.14575. Epub 2023 Aug 21. No abstract available.

  PMID: 37605035 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: March 2, 2022
• Study Start: May 12, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-06

Locations

IT (1)