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

PROTECT-Surg

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202004893013257

Enrollment

6400

Registered

2020-04-23

Start date

2020-04-25

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

COVID-19

Interventions

Hydroxychloroquine

Lopinavir Ritonavir

Hydroxychloroquine plus Lopinavir Ritonavir

normal practice neither trial drug

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients aged 16 years and over in Ghana. (This criteria MUST be made country-specific) • 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, positive test but no symptoms • Informed patient consent.

Exclusion criteria

Exclusion criteria: • 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). • Actively breastfeeding.

Design outcomes

Primary

Measure	Time frame
•Pneumonia •Acute respiratory distress syndrome (ARDS) •Death	—

Secondary

Measure	Time frame
• Pneumonia, ARDS, and death will be presented and analysed separately as secondary outcomes as well as within the composite primary outcome measure. • Unexpected ventilation (unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation up to 30 days after surgery) • Postoperative diagnosis of proven COVID-19 pulmonary complications (the method of diagnosis will be collected, i.e. infection based on microbiological testing or clinical features) • Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic). • Duration of hospital stay (including time spent in intensive care, time ventilated) • Pulmonary function in keeping with the WHO Solidarity Trial outcome scale (will be detailed in Appendix 2)	—

Measure

Time frame

• Pneumonia, ARDS, and death will be presented and analysed separately as secondary outcomes as well as within the composite primary outcome measure. • Unexpected ventilation (unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation up to 30 days after surgery) • Postoperative diagnosis of proven COVID-19 pulmonary complications (the method of diagnosis will be collected, i.e. infection based on microbiological testing or clinical features) • Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic). • Duration of hospital stay (including time spent in intensive care, time ventilated) • Pulmonary function in keeping with the WHO Solidarity Trial outcome scale (will be detailed in Appendix 2)

—

Countries

Ghana

Contacts

Public ContactSohini Chakrabortee

NIHR Global Health Research Unit on Global Surgery

s.chakrabortee@bham.ac.uk+441213718121

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026