NCT04459390

Brief Summary

Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

July 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

July 5, 2020

Last Update Submit

August 4, 2020

Conditions

COVID19

Outcome Measures

Primary Outcomes (2)

  • Rate of recovery/ ICU admission/ need for mechanical ventilation

    The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.

    Baseline

  • Time to improvement

    Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.

    Baseline

Study Arms (2)

COVID19 with comorbidities

Patients with COVID19 with at least one of the following comorbidities: 1. Hypertension 2. Diabetes 3. Cardiovascular disease 4. Chronic pulmonary disease 5. Obesity 6. Chronic liver disease 7. Chronic kidney disease 8. Collagen vascular disease 9. Autoimmune disease 10. Malignancy

Diagnostic Test: realtime PCR

COVID19 without comorbidities

Patients with COVID19 without any of the previously mentioned comorbidities

Diagnostic Test: realtime PCR

Interventions

realtime PCRDIAGNOSTIC_TEST

Detection of SARS-CoV-2 genes by realtime PCR

COVID19 with comorbiditiesCOVID19 without comorbidities

Eligibility Criteria

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

Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. All patients will be subjected to full clinical assessment, some laboratory investigations which are potential marker of disease severity. Another studies include chest X ray and CT chest.

You may qualify if:

  • Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

RECRUITING

Related Publications (3)

  • Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

    PMID: 32173574BACKGROUND

  • Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.

    PMID: 32271993BACKGROUND

  • Badawi A, Ryoo SG. Prevalence of comorbidities in the Middle East respiratory syndrome coronavirus (MERS-CoV): a systematic review and meta-analysis. Int J Infect Dis. 2016 Aug;49:129-33. doi: 10.1016/j.ijid.2016.06.015. Epub 2016 Jun 21.

    PMID: 27352628BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing an upper respiratory specimen. The following are acceptable specimens: * A nasopharyngeal (NP) specimen collected by a healthcare provider; or * An oropharyngeal (OP) specimen collected by a healthcare provider; or * Sputum specimen collected by a healthcare provider. Swab specimens should be collected using only swabs with a synthetic tip, and an aluminum or plastic shaft. Place swabs immediately into sterile tubes containing 2-3 mL of viral transport media. Store the samples at 2-8°C up to 72 hours. If a delay in shipping or extraction is expected, store samples at -70°C in accordance with CDC's protocol.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hebatallah Hassan

CONTACT

01022182086heba.ismailhassan@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 7, 2020

Study Start

July 20, 2020

Primary Completion

October 20, 2020

Study Completion

November 20, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

EG(1)