Prevention of Respiratory Complications In At Surgery in COVID-19 Pandemic

Preventing Pulmonary Complications In Surgical Patients At Risk Of COVID-19 - PROTECT-Surg

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026196

Enrollment

6400

Registered

2020-06-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Lopinavir-Ritonavir: Lopinavir is a HIV-1 (Human Immunodeficiency Virus 1) protease inhibitor, normally used as part of combined drug therapy for HIV. Ritonavir is added to Lopinavir to

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 16 years and over. 2. 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). 3. Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms 4. Informed patient consent.

Exclusion criteria

Exclusion criteria: 1. Procedures under local anaesthesia. 2. Symptomatic COVID-19 infection (by confirmed COVID-19 test or a clinical diagnosis) 3. Existing regular preoperative treatment with trial drugs. 4. Known history of adverse reaction/contraindication to trial drugs. 5.Pregnancy (including caesarean section). • Actively breastfeeding.

Design outcomes

Primary

Measure	Time frame
One of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia, Acute respiratory distress syndrome, Death Timepoint: All randomised participants will be followed up until death, discharge from hospital, or 30 days post-randomisation (whichever is sooner). Longer-term follow-up (e.g. 5 years) will be sought as appropriate to each participating countryâ??s settings.	—

Measure

Time frame

One of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia, Acute respiratory distress syndrome, Death Timepoint: All randomised participants will be followed up until death, discharge from hospital, or 30 days post-randomisation (whichever is sooner). Longer-term follow-up (e.g. 5 years) will be sought as appropriate to each participating countryâ??s settings.

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Secondary

Measure	Time frame
Pneumonia, ARDS, and death will be presented and analysed separately as secondary outcomes. Unexpected ventilation Postoperative diagnosis of proven COVID-19 pulmonary complications Overall SARS-CoV-2 infected rate Duration of hospital stay (including time spent in intensive care, time ventilated) Pulmonary function in keeping with the WHO Solidarity Trial outcome scaleTimepoint: Secondary outcome measures will be recorded on the index hospital admission up to 30 days following surgery	—

Measure

Time frame

Pneumonia, ARDS, and death will be presented and analysed separately as secondary outcomes. Unexpected ventilation Postoperative diagnosis of proven COVID-19 pulmonary complications Overall SARS-CoV-2 infected rate Duration of hospital stay (including time spent in intensive care, time ventilated) Pulmonary function in keeping with the WHO Solidarity Trial outcome scaleTimepoint: Secondary outcome measures will be recorded on the index hospital admission up to 30 days following surgery

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Countries

Benin, Ghana, India, Italy, Mexico, Nigeria, Rwanda, South Africa, United Kingdom

Contacts

Public ContactAmit Mahajan

Christian Medical College Ludhiana

dr_amitrock@yahoo.co.in9988018700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026