NCT04433026

Brief Summary

To evaluate the role of N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and Troponin - I as risk factors in COVID-19 patients and to correlate these markers with in-hospital death in patients with COVID-19

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 21, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 14, 2020

Last Update Submit

August 20, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Measurement of N-terminal pro-B type natriuretic peptide, troponin-I and D-dimer in COVID-19 patients

    Measurement of the level of these markers in COVID-19 patients and collerate these measurements with early signs of cardiac injury in COVID-19 patients

    Baseline

  • Cardiac complications in COVID-19 patients associated with more adverse effects

    Measurement of the level of N-terminal pro-B type natriuretic peptide, Troponin-I and D-dimer may help in detection of early signs of cardiac injury which in turn may help to minimize the risk of in-hospital deaths in COVID-19 patients

    Baseline

Interventions

Biomarkers detected in the serum of patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study initially enrolled 90 patients with COVID-19

You may qualify if:

  • patients with COVID-19 (moderate and severe cases) Different age groups

You may not qualify if:

  • Patients who had stroke and acute myocardial infarction, malignant tumor, and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

    PMID: 32211816BACKGROUND
  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PMID: 32171076BACKGROUND
  • Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

    PMID: 32219356BACKGROUND
  • Libby P. The Heart in COVID-19: Primary Target or Secondary Bystander? JACC Basic Transl Sci. 2020 Apr 10;5(5):537-542. doi: 10.1016/j.jacbts.2020.04.001. eCollection 2020 May.

    PMID: 32292847BACKGROUND
  • Wang J, Hajizadeh N, Moore EE, McIntyre RC, Moore PK, Veress LA, Yaffe MB, Moore HB, Barrett CD. Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): A case series. J Thromb Haemost. 2020 Jul;18(7):1752-1755. doi: 10.1111/jth.14828. Epub 2020 May 11.

    PMID: 32267998BACKGROUND
  • Porfidia A, Pola R. Venous thromboembolism in COVID-19 patients. J Thromb Haemost. 2020 Jun;18(6):1516-1517. doi: 10.1111/jth.14842. No abstract available.

    PMID: 32294289BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 16, 2020

Study Start

August 1, 2020

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

August 21, 2020

Record last verified: 2020-06