Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection

NCT04441372 | Unknown

• 1 other identifier: MSF0001
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 3

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 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

Conditions

SARS-CoV2; COVID

Keywords

SARS-CoV-2; COVID-19; Prognosis; Oxygen

Outcome Measures

Primary Outcomes (1)

• Clinical and biochemical prognostic markers

  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.

  14 days

Secondary Outcomes (1)

• Evaluate field-based performance of POC

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at two study sites in India: AIIMS Patna and CMC Vellore. Both sites are recognised by the government and Health Clusters as COVID-19 management facilities. Other study sites may be added over time.

You may qualify if:

• The participant may enter the study if ALL of the following apply:
• Aged ≥ 18 years, and willing and able to give informed consent and comply with study procedures;
• RT-PCR or antigen test positive for SARS-CoV-2 during current illness
• Systemic manifestation of SARS-CoV-2 infection defined as:
• Breathing difficulty
• History of fever during current illness AND chest pain OR abdominal pain OR loose stool OR severe myalgia

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Requires supplemental oxygen or mechanical ventilation (invasive / non-invasive) at presentation;
• Laboratory confirmed SARS-CoV-2 infection (virological or serological) during a previous illness episode.
• Documented history of Vaccination for SARS-Cov-2

Sponsors & Collaborators

• Medecins Sans Frontieres, Spain: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Foundation for Innovative New Diagnostics, Switzerland: collaborator

Study Sites (3)

Foundation for Scientific and Technological Development in Health (FIOTEC)

Rio de Janeiro, 4036, Brazil

RECRUITING

All India Institute of Medical Sciences Patna (AIIMS)

Patna, Bihar, 801507, India

COMPLETED

Christian Medical College, Vellore

Vellore, Tamil Nadu, 632004, India

COMPLETED

Related Publications (1)

• Chandna A, Mahajan R, Gautam P, Mwandigha L, Gunasekaran K, Bhusan D, Cheung ATL, Day N, Dittrich S, Dondorp A, Geevar T, Ghattamaneni SR, Hussain S, Jimenez C, Karthikeyan R, Kumar S, Kumar S, Kumar V, Kundu D, Lakshmanan A, Manesh A, Menggred C, Moorthy M, Osborn J, Richard-Greenblatt M, Sharma S, Singh VK, Singh VK, Suri J, Suzuki S, Tubprasert J, Turner P, Villanueva AMG, Waithira N, Kumar P, Varghese GM, Koshiaris C, Lubell Y, Burza S. Facilitating Safe Discharge Through Predicting Disease Progression in Moderate Coronavirus Disease 2019 (COVID-19): A Prospective Cohort Study to Develop and Validate a Clinical Prediction Model in Resource-Limited Settings. Clin Infect Dis. 2022 Aug 24;75(1):e368-e379. doi: 10.1093/cid/ciac224.

  PMID: 35323932 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be taken for biomarker assessment from all participants and may include pathogen identification

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arjun Chandna, MD

  Cambodia Oxford Medical Research Unit

  PRINCIPAL INVESTIGATOR

• Sakib Burza, PhD

  Medecins Sans Frontieres, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhael Yosia, MD

CONTACT

+6281378778784; msfe-jakarta-med@barcelona.msf.org

Arjun Chandna, MD

CONTACT

+85585712586; arjun@tropmedres.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-02

Locations

IN (2); BR (1)