Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection : A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
ClinicalTrials.gov - (2021) vom: 17. Dez. Zur Gesamtaufnahme - year:2021 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: August 26, 2020, Last downloaded: ClinicalTrials.gov processed this data on December 27, 2021, Last updated: December 29, 2021 |
|---|
| Study ID: |
NCT04526912 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG003498239 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG003498239 | ||
| 003 | DE-627 | ||
| 005 | 20230425221712.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210408s2021 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG003498239 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT04526912 | ||
| 035 | |a (UBBS_Klinische_Studien)VIB7734.P1.S2 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection |b A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: August 26, 2020, Last downloaded: ClinicalTrials.gov processed this data on December 27, 2021, Last updated: December 29, 2021 | ||
| 520 | |a This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed. | ||
| 650 | 2 | |a Lung Injury | |
| 650 | 2 | |a Acute Lung Injury | |
| 650 | 2 | |a Wounds and Injuries | |
| 650 | 4 | |a Medical Condition: Acute Lung Injury | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2021) vom: 17. Dez. |
| 773 | 1 | 8 | |g year:2021 |g day:17 |g month:12 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04526912 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2021 |b 17 |c 12 | ||