Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection
Conditions
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.
Interventions
DRUGPamrevlumab
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients not on ventilatory support | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| PaO2/FiO2 ratio as categorical variable | Day14 |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed