COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001448-24/GB

University of Birmingham, Birmingham Clinical Trials Unit (BCTU) - Donna Smith

d.smith.6@bham.ac.uk

2020-04-17

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

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.

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.

4

University of Birmingham

18

None

Ghana;India;Nigeria;South Africa;United Kingdom

High risk patients

N/A

3000

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).

Declared number of arm (4.0) differs from found arms (2.0)

Phase 3

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