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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamrevlumab | Experimental |
| |
| Standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients not on ventilatory support | 15 days |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli IRCCS | Rome | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37605035 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C560078 | pamrevlumab |
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