treatment and prevention of acute lung injury (ali) in patients with covid-19 infection

Conditions: Acute Lung Injury

Summary: the study aims 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. subjects will be administered a single dose of vib7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.

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.

Eligibility criteria:
key inclusion criteria: * hospitalized with coronavirus disease 2019 (covid-19) pneumonia confirmed by world health organization criteria. * oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen \ 200 mm hg. * negative influenza test. * lymphocyte counts \< 10\^3/μl and the presence of at least one of the following markers of hyperinflammation within 1 day prior to vib7734 administration: * elevated high sensitivity c-reactive protein (hscrp) \> 50 mg/l * ferritin \> 500 ng/ml * lactate dehydrogenase (ldh) \> 300 u/l * d-dimers \> 500 ng/ml note: other protocol defined inclusion criteria apply key exclusion criteria: * respiratory failure requiring mechanical ventilation. * in the opinion of the investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours. * valid do not intubate (dni) or do not resuscitate (dnr) order. * anticipated duration of hospital stay \< 72 hours. * history of allergy or hypersensitivity reaction to any component of the ip. * participation in another clinical study with an ip within 4 weeks prior to day 1 or within 5 half-lives of the ip, whichever is longer. (participation in covid-19 antiviral or antimalarial trials may be permitted after discussion with the medical monitor). * liver cirrhosis or liver failure. * known human immunodeficiency virus infection. * known hepatitis b or known hepatitis c infection in the absence of a history of curative therapy. * known or suspect active or latent tuberculosis infection. * active bacterial, fungal, viral, or other infection (besides covid-19). * clinically significant cardiac disease within 6 months. * history of severely impaired respiratory function at baseline (not related to covid-19) based on requirement for home oxygen of \> 4 l/min or based on other medical history known to the investigator. * history of cancer within 12 months of enrollment. * receipt of chemotherapy, biologic immunomodulators (including jak inhibitors), or immunosuppressive therapies within 8 weeks of enrollment, or receipt of rituximab or other b cell-depleting mab therapy within 6 months. note: other protocol defined exclusion criteria apply

Keywords: pneumonia covid-19 sars-cov-2 acute respiratory disease