Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID
- Pulmonary Complications in Surgical Patients
- Severe Acute Respiratory Syndrome
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The trial uses a Bayesian adaptive platform design, allowing for termination of arms if their superiority to standard care is established, and addition of new treatment arms. Patients will be randomised 1:1:1:1 to (A) Control (normal practice; neither trial drug), (B) Lopinavir-Ritonavir only, (C) Hydroxychloroquine only, (D) both Lopinavir-Ritonavir and Hydroxychloroquine.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 16 years and 125 years
- Gender
- Both males and females
Description
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allow...
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between: A. Control (normal practice; neither trial drug) B. Lopinavir 400mg-Ritonavir 100mg by mouth every 12 hours for 10 days or until discharge, whichever occurs first C. Hydroxychloroquine 400mg BD day 1; then 400mg daily day 2-5 or until discharge, whichever occurs first D. Both trial drug regimens
Tracking Information
- NCT #
- NCT04386070
- Collaborators
- Christian Medical College and Hospital, Ludhiana, India
- Tamale Teaching Hospital, Ghana.
- University of Lagos, Nigeria
- Kigali University Teaching Hospital
- Hospital Español Veracruz
- Université d'Abomey-Calavi
- University of Witwatersrand, South Africa
- University of Edinburgh
- Istituto Clinico Humanitas
- University of Cape Town
- Investigators
- Principal Investigator: Aneel Bhangu University of Birmingham
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