PRIORITISE Study: Oxygen Requirement In Non-Severe COVID-19 Patients

Description of the Study:

• Title: Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection (PRIORITISE).
• Principal Investigators: Arjun Chandna and Sakib Burza.
• Centers of Implementation: The study will be conducted at two sites in India: AIIMS Patna and CMC Vellore. Both sites are recognised by the government and health groups as COVID-19 management facilities. Other study sites may be added over time.
• Study Population: The initial planned sample size is 600 participants per country, aged 18 years and older who have tested positive by RT-PCR or antigen testing for SARS-CoV-2 and have systemically manifested SARS-CoV-2 infection.
• Type of Study: Prospective longitudinal observational study.
• Methods:
  – Clinical and biochemical prognostic markers will be assessed through the markers’ ability to predict progression to subsequent need for supplemental oxygen: sensitivity, specificity, NPV, PPV and AUROC, and discrimination (c-index) and calibration (plots of observed versus predicted probabilities) of a prognostic model combining up to four markers.
  – Field performance of the POC will be assessed by observing the correlation of near-patient lateral flow assays and the gold standard of the instrumented multi-analyte immunoassay.

Objectives of the Study:

Principal Objective: To identify clinical and biochemical prognostic markers in adults with laboratory-confirmed SARS-CoV-2 infection who do not require oxygen supplementation at presentation, with the aim of:
(1) Aid safe discharge from a healthcare facility (i.e. high NPV).
(2) Achieve a short-term impact on COVID-19 interventions in resource-limited settings.

Secondary Objective: To evaluate the POC field performance of near-patient lateral flow trials for suPAR in adults with non-severe SARS-CoV-2 infection.

More about this Study:

The overall aim of the PRIORITISE project is to develop and validate a simple, practical tool to aid the triaging of patients with COVID-19 in resource-limited settings, to improve identification of patients at risk of deterioration and prevent overburdening of health facilities. Having the ability to prognosticate the need for supplemental oxygen (the main treatment available in resource-limited settings) through measurement of parameters available at the time of arrival at a healthcare facility would strengthen the ability to identify the patients with moderate symptoms that can be safely discharged.

A limitation of this study is that because it is conducted at a single site, it will not be able to explore whether the performance of the prognostic markers is affected by different host populations, or perform external geographic validation of the prognostic model. To mitigate this risk we have designed a pragmatic study that could be implemented elsewhere. Options for conducting the study elsewhere are being actively explored if sufficient additional funding is secured.

The sponsors and collaborators of this study are Médecins Sans Frontières (Spain), the Mahidol Oxford Research Unit for Tropical Medicine (MORU), the International Centre for Diarrhoeal Disease Research (Bangladesh) and the Foundation for Innovative New Diagnostics (Switzerland).