A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial.
Keisha SmithAmy PaceStephan OrtizShamsah KazaniScott RottinghausPublished in: Trials (2020)
Clinicaltrials.gov: Protocol Registry Number: NCT04369469 ; First posted; 30 Apr 2020 EU Clinical Trials Register: EudraCT Number: https://www.clinicaltrialsregister.eu/ctr-search/search?query=ALXN1210-COV-305 , Start date: 07 May 2020 FULL PROTOCOL: The full redacted protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Keyphrases
- acute respiratory distress syndrome
- open label
- clinical trial
- randomized controlled trial
- phase ii
- extracorporeal membrane oxygenation
- phase iii
- healthcare
- mechanical ventilation
- sars cov
- double blind
- study protocol
- palliative care
- quality improvement
- lps induced
- early onset
- phase ii study
- health insurance
- drug induced