Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Lopinavir-Ritonavir
Product Name: Lopinavir-Ritonavir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lopinavir
Other descriptive name: Antiretroviral
Concentration unit: mg
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Testing and criteria for diagnosis COVID-19 is likely to rapidly evolve over the course of this trial and will vary internationally. Therefore, the following pragmatic definitions will be applied: • Confirmed positive test for COVID-19: either a laboratory test (performed according to each participating hospital’s local protocols) or a computed tomography (CT) thorax scan (based on individual radiologist interpretation and diagnosis) that confirms COVID-19 diagnosis. • Confirmed negative test for COVID-19: a laboratory test (performed according to each participating hospital’s local protocols) that is negative for COVID-19 diagnosis. Patients are eligible for the study if ALL of the following apply: -Aged 18 years or above -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, postive test but no symptoms -Able to provide informed patient consent The eligibility criteria may change over time to reflect new diagnostic tests or changing epidemiology. This will be reviewed regularly by the Trial Management Group and Data Monitoring Committee. For example, if routine serological screening before surgery becomes feasible during the course of the trial in any participating hospital, only seronegative patients may be eligible for the trial. Are the trial subjects under 18? no Number of subjects for this age range: 1000 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: Patients are not eligible for the study if ANY of the following apply: --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) It is anticipated that very few patients listed for surgery will have symptomatic COVID-19 infection at the time of surgery, and although any such patients will be excluded from this trial, they will be eligible for the parallel RECOVERY trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective To provide reliable estimates of the effect of study treatments on postoperative pulmonary complications during the COVID-19 pandemic. ;Secondary Objective: To assess the effects of study treatments on: -Post-operative proven COVID-19 pulmonary complications -Overall SARS-CoV-2 infected rate -Duration of intensive care and total hospital stay -Pulmonary function in keeping with WHO Solidarity Trial outcome scale -Safety and tolerability of study treatments ;Primary end point(s): Trial outcomes will only be based on routinely available data. Patients will not undergo any additional investigations for trial purposes. Primary outcome measure The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications (definitions are given in an Appendix in the protocol and through brief online training): • Pneumonia • Acute respiratory distress syndrome (ARDS) • Death Definitions for each outcome are provided in the protocol. The components of the composite outcome have all been internationally validated. The feasibility of collecting these endpoints within routine care pathways has been demonstrated by our RECON cohort (11,500 patients, 4 countries). ;Timepoint(s) of evaluation of this end point: Up to 30 days following surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Pneumonia -Acute respiratory distress syndrome (ARDS) -Death -Unexpected ventilation (unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation after surgery) -Postoperative diagnosis of COVID-19 infection based on microbiological testing or clinical features -Duration of hospital stay (including time spent in intensive care as well as ward level care) -Pulmonary function in keeping with the WHO Solidarity Trial outcome scale ;Timepoint(s) of evaluation of this end point: Up to 30 days post surgery | — |
Countries
Ghana, India, Nigeria, South Africa, United Kingdom
Contacts
Public ContactDonna Smith
University of Birmingham, Birmingham Clinical Trials Unit (BCTU)
Outcome results
None listed