Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19

Phase 1

• Conditions: Preventing 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]

• Registration Number: EUCTR2020-001448-24-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified