Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support
Summary
This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo. All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and 14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.
Timeline
- Start
- 2020-09-23
- Primary completion
- 2022-05-20
- Completion
- 2022-06-22
Outcome
Met primary endpoint
paper Nangibotide therapy was associated with an improved clinical status at day 28. PMID 37350989 ↗
paper an odds ratio (95% CI) for improvement of 1.79 (1.02-3.14), p = 0.043. PMID 37350989 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | nangibotide | Peptide | 1 mg/kg | Intravenous |