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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 : July 2, 2020
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit (MORU)
International Centre for Diarrhoeal Disease Research, Bangladesh
Foundation for Innovative New Diagnostics, Switzerland
Information provided by (Responsible Party):
Medecins Sans Frontieres, Spain

Brief Summary:

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 determine the performance of LMIC-friendly POC or near-patient prognostic tests in adults with non-severe COVID-19.


Condition or disease
SARS-CoV2 COVID

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Performance of LMIC-friendly POC [ Time Frame: 14 days ]
    Determine the performance of LMIC-friendly POC or near-patient prognostic tests in adults with non-severe COVID-19. This is assessed through the ability of the test to predict progression to subsequent supplemental oxygen requirement - sensitivity, specificity, NPV, PPV and AUROC


Biospecimen Retention:   Samples With DNA
Blood will be taken for biomarker assessment from all participants and may include pathogen identification


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study site will be in southern Cox Bazar, Bangladesh, adjacent to a large Rohingya refugee camp. The site will cater to a mixture of both host and refugee populations.
Criteria

Inclusion Criteria:

The participant may enter the study if ALL of the following apply:

  1. Willing and able to give informed consent and comply with study procedures;
  2. Aged ≥ 18 years;
  3. Axillary temperature at presentation ≥ 37.5°C OR history of fever in last 24h;
  4. Cough OR shortness of breath OR difficulty breathing.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

  1. No limitation of daily activities (WHO COVID-19 Clinical Progression Scale Grade ≤ 2);
  2. Requires supplemental oxygen at presentation (WHO COVID-19 Clinical Progression Scale Grade ≥ 5);
  3. Currently enrolled in study and under follow-up (not yet reached D14);
  4. Previous laboratory-confirmed SARS-CoV-2 infection (virological or serological).

Information from the National Library of Medicine

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


Contacts
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Contact: Mikhael Yosia, MD +6281378778784 msfe-jakarta-med@barcelona.msf.org
Contact: Arjun Chandna, MD +85585712586 arjun@tropmedres.ac

Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Contact: Mohammad Shomik, MD    +8801714132715    mshomik@icddrb.org   
Sponsors and Collaborators
Medecins Sans Frontieres, Spain
Mahidol Oxford Tropical Medicine Research Unit (MORU)
International Centre for Diarrhoeal Disease Research, Bangladesh
Foundation for Innovative New Diagnostics, Switzerland
Investigators
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Principal Investigator: Arjun Chandna, MD Cambodia Oxford Medical Research Unit
Principal Investigator: Sakib Burza, PhD Medecins Sans Frontieres, Spain
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Responsible Party: Medecins Sans Frontieres, Spain
ClinicalTrials.gov Identifier: NCT04441372    
Other Study ID Numbers: MSF0001
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medecins Sans Frontieres, Spain:
SARS-CoV-2
COVID-19
Prognosis
Oxygen
Additional relevant MeSH terms:
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Infection