Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (PROTECT-Surg)
Sponsor: Christian Medical College and Hospital, Ludhiana, India
Suspended
Lack of IMP availability - may resume.
A PHASE3 clinical study on COVID and Pulmonary Complications in Surgical Patients, this trial is suspended. The trial is conducted by Christian Medical College and Hospital, Ludhiana, India and has accumulated 9 data snapshots since 2022. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC.
Eligible patients will be randomised at the level of the individual in a 1:1 ratio between:
A. Control (normal practice) B. RESP301 6ml mixture of 150mM sodium nitrate, 50mM mannitol and 100mM citric acid, buffered at pH 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC.
Eligible patients will be randomised at the level of the individual in a 1:1 ratio between:
A. Control (normal practice) B. RESP301 6ml mixture of 150mM sodium nitrate, 50mM mannitol and 100mM citric acid, buffered at pH 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first
Status Flow
Change History
9 versions recorded-
Jun 2025 — Present [monthly]
Suspended PHASE3
-
Mar 2025 — Jun 2025 [monthly]
Suspended PHASE3
Status: Not Yet Recruiting → Suspended
-
Sep 2024 — Mar 2025 [monthly]
Not Yet Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Not Yet Recruiting PHASE3
-
Sep 2021 — Jul 2024 [monthly]
Not Yet Recruiting PHASE3
▶ Show 4 earlier versions
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May 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE3
-
Jan 2021 — May 2021 [monthly]
Not Yet Recruiting PHASE3
-
Dec 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE3
-
Jun 2020 — Dec 2020 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Christian Medical College and Hospital, Ludhiana, India
- Hospital Español Veracruz
- Istituto Clinico Humanitas
- Kigali University Teaching Hospital
- Ministry of Health, Ghana
- University of Birmingham
- University of Cape Town
- University of Edinburgh
- University of Lagos, Nigeria
- University of Witwatersrand, South Africa
- Université d'Abomey-Calavi
For direct contact, visit the study record on ClinicalTrials.gov .