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NCT05262309: FibroCov-01
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
Phase 2, PHASE3 trial testing Pamrevlumab in COVID-19 Respiratory Infection in 42 participants. Completed in 1 January 2022.
1 January 2022
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 12 May 2020 |
| Primary completion | 1 January 2022 |
| Estimated completion | 1 January 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Pamrevlumab — full drug profile →
Conditions studied
- COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →
- COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →
- Covid19 — all drugs for Covid19 →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 18 to 80, any sex, with COVID-19 Respiratory Infection or COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development of therapeutic antibodies for the treatment of diseases.
Wang Z, Wang G, Lu H, Li H, et al · · 2022 · cited 69× · PMID 36418786 · DOI 10.1186/s43556-022-00100-4 -
Connective Tissue Growth Factor: Regulation, Diseases, and Drug Discovery.
Ren M, Yao S, Chen T, Luo H, et al · · 2024 · cited 10× · PMID 38731911 · DOI 10.3390/ijms25094692
Verify or expand the search:
- PubMed search for NCT05262309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pamrevlumab
Trials testing the same drug.
- NCT04632940 — Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD · Phase 3 · terminated
- NCT04419558 — Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) · Phase 3 · terminated
- NCT04371666 — Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscu · Phase 3 · terminated
- NCT04432298 — Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease · Phase 2 · terminated
- NCT03955146 — Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) · Phase 3 · terminated
Other recruiting trials for COVID-19 Respiratory Infection
Currently open trials in the same condition.
- NCT06950177 — Pancoronavirus Vaccine Study in Healthy Adults · Phase 1 · active not recruiting
- NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
- NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
- NCT05689034 — Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 · Phase 2, PHASE3 · recruiting
- NCT05562505 — Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure · NA · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
- NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
- NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
- NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05262309 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05262309.
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