Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection (PRIORITISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04441372|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : August 14, 2020
Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford.
The primary objective of this study is to identify clinical and biochemical prognostic markers in adults with virologically confirmed COVID-19 who do not require oxygen supplementation, with a focus on: aiding safe discharge from a healthcare facility (i.e. a high NPV); near-term impact on COVID-19 interventions in resource-limited settings (i.e. simple clinico-demographic variables and biochemical markers for which near-patient / POCTs are commercially available or in late-stage development).
The secondary objective of this study is to evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1200 participants|
|Target Follow-Up Duration:||14 Days|
|Official Title:||Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||April 1, 2021|
- Clinical and biochemical prognostic markers [ Time Frame: 14 days ]Identify clinical and biochemical prognostic markers in adults with non-severe COVID-19. This is assessed through the ability of the markers to predict progression to subsequent supplemental oxygen requirement - sensitivity, specificity, NPV, PPV and AUROC, and discrimination (c-index) and calibration (plots of observed probabilities against predicted probabilities) of a prognostic model combining up to four markers.
- Evaluate field-based performance of POC [ Time Frame: 14 days ]To evaluate the field-based performance of near-patient lateral flow assays for suPAR and IL-6 in adults with non-severe SARS-CoV-2 infection. This is assessed through looking at correlation of the near-patient lateral flow assays and the instrumented multi-analyte immunoassaygold standard.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441372
|Contact: Mikhael Yosia, MDemail@example.com|
|Contact: Arjun Chandna, MDfirstname.lastname@example.org|
|International Centre for Diarrhoeal Disease Research|
|Contact: Mohammad Shomik, MD +8801714132715 email@example.com|
|Principal Investigator:||Arjun Chandna, MD||Cambodia Oxford Medical Research Unit|
|Principal Investigator:||Sakib Burza, PhD||Medecins Sans Frontieres, Spain|