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Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (PROTECT-Surg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386070
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
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
Information provided by (Responsible Party):
University of Birmingham

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date May 13, 2020
Estimated Study Start Date  ICMJE May 15, 2020
Estimated Primary Completion Date May 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death [ Time Frame: From randomisation until discharge from hospital, average less than 30 days ]
The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Rate of Pneumonia [ Time Frame: From randomisation until discharge from hospital, average less than 30 days ]
    Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.
  • Rate of ARDs [ Time Frame: From randomisation until discharge from hospital, average less than 30 days ]
    ARDs will be presented and analysed separately as a secondary outcome measure
  • Death rate [ Time Frame: From randomisation until discharge from hospital, average less than 30 days ]
    Death will be presented and analysed separately as a secondary outcome measure
  • Rate of unexpected ventilation [ Time Frame: From operation until 30 days post operation ]
    Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery
  • COVID-19 pulmonary complications [ Time Frame: 30 days post-surgery ]
    Postoperative diagnosis of proven COVID-19 pulmonary complications
  • Overall SARS-CoV-2 infected rate [ Time Frame: 30 days post-surgery ]
    Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic)
  • Duration of hospital stay [ Time Frame: 30 days post-surgery ]
    Duration of hospital stay (including time spent in intensive care, time ventilated)
  • Pulmonary function [ Time Frame: 30 days post-surgery ]
    Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Official Title  ICMJE Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Brief Summary The aim of this study is to reduce COVID-19 related pulmonary complications in adult patients undergoing all types of elective or emergency surgery in a COVID-19 exposed environment. A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
Detailed 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, 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Condition  ICMJE
  • Pulmonary Complications in Surgical Patients
  • COVID
  • Severe Acute Respiratory Syndrome
Intervention  ICMJE
  • Drug: Lopinavir-Ritonavir
    Lopinavir-Ritonavir only
  • Drug: Hydroxychloroquine
    Hydroxychloroquine only
Study Arms  ICMJE
  • No Intervention: Control (normal practice; neither trial drug)
    Treatment without the trial drugs. Patients will be treated as per hospital routine practice without receiving any of the drugs given in the intervention arms.
  • Experimental: Lopinavir-Ritonavir
    Lopinavir 400mg-Ritonavir 100mg by mouth every 12 hours. Started on the morning of surgery, given for 10 days or until discharge, whichever occurs first.
    Intervention: Drug: Lopinavir-Ritonavir
  • Experimental: Hydroxychloroquine
    Hydroxychloroquine 400mg BD day 1; then 400mg daily day 2-5. Started on the morning of surgery, given until day 5 postoperatively or until discharge, whichever occurs first.
    Intervention: Drug: Hydroxychloroquine
  • Experimental: Lopinavir-Ritonavir and Hydroxychloroquine
    Lopinavir 400mg-Ritonavir 100mg by mouth every 12 hours for 10 days or until discharge, whichever occurs first AND Hydroxychloroquine 400mg BD day 1; then 400mg daily day 2-5 or until discharge, whichever occurs first.
    Interventions:
    • Drug: Lopinavir-Ritonavir
    • Drug: Hydroxychloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
6400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 14, 2026
Estimated Primary Completion Date May 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 16 years and over in the UK. (This criteria MUST be made country-specific)
  • Planned to undergo any type of elective or emergency inpatient surgery requiring general or regional anaesthesia (such as vulnerable patients undergoing surgery for a fractured neck of femur).
  • Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms
  • Informed patient consent.

Exclusion Criteria:

  • Procedures under local anaesthesia.
  • Symptomatic COVID-19 infection (by confirmed COVID-19 test or a clinical diagnosis); these patients will be eligible for the RECOVERY trial.
  • Existing regular preoperative treatment with trial drugs.
  • Known history of adverse reaction/contraindication to trial drugs.
  • Pregnancy (including caesarean section).
  • Actively breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Lillywhite +44 (0)121 414 4762 PROTECT-Surg@trials.bham.ac.uk
Contact: Donna Smith +44 (0)121 415 9103 PROTECT-Surg@trials.bham.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04386070
Other Study ID Numbers  ICMJE RG_20-029 COVID-19
2020-001448-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
Responsible Party University of Birmingham
Study Sponsor  ICMJE University of Birmingham
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Aneel Bhangu University of Birmingham
PRS Account University of Birmingham
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP