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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

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)

Condition or disease Intervention/treatment Phase
Pulmonary Complications in Surgical Patients COVID Severe Acute Respiratory Syndrome Drug: Lopinavir-Ritonavir Drug: Hydroxychloroquine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6400 participants
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
Official Title: Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : May 14, 2021
Estimated Study Completion Date : May 14, 2026


Arm Intervention/treatment
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.
Drug: Lopinavir-Ritonavir
Lopinavir-Ritonavir only

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.
Drug: Hydroxychloroquine
Hydroxychloroquine only

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.
Drug: Lopinavir-Ritonavir
Lopinavir-Ritonavir only

Drug: Hydroxychloroquine
Hydroxychloroquine only




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. COVID-19 pulmonary complications [ Time Frame: 30 days post-surgery ]
    Postoperative diagnosis of proven COVID-19 pulmonary complications

  6. Overall SARS-CoV-2 infected rate [ Time Frame: 30 days post-surgery ]
    Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic)

  7. Duration of hospital stay [ Time Frame: 30 days post-surgery ]
    Duration of hospital stay (including time spent in intensive care, time ventilated)

  8. Pulmonary function [ Time Frame: 30 days post-surgery ]
    Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386070


Contacts
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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

Sponsors and Collaborators
University of Birmingham
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
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Principal Investigator: Aneel Bhangu University of Birmingham
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04386070    
Other Study ID Numbers: RG_20-029 COVID-19
2020-001448-24 ( EudraCT Number )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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).

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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
Keywords provided by University of Birmingham:
Surgery
Pneumonia
COVID 19
COVID
SARS-Cov-2
SARS
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ritonavir
Lopinavir
Hydroxychloroquine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents