TerminatedPhase 1

Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection

Stopped: Study met predefined futility criteria for efficacy endpoints.

United States10 participantsStarted 2020-08-28

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \< 300 mm Hg and \> 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 abse…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness

Timeframe: Day 1 (Baseline) through Day 28

Trial details

NCT IDNCT04526912

SponsorViela Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-08

View on ClinicalTrials.gov More Acute Lung Injury trials