Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 - COVIDSurgRCT_v1.0_20200330

niversity of Birmingham0 sites6,400 target enrollmentApril 17, 2020

ConditionsPreventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 MedDRA version: 20.0Level: PTClassification code 10035664Term: PneumoniaSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 100000004855 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsLopinavir-Ritonavir Hydroxychloroquine (Plaquenil)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Sponsor: niversity of Birmingham
Enrollment: 6400
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 17, 2020

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Birmingham

Eligibility 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

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.