Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05092555
Collaborator
(none)
200
8

Study Details

Study Description

Brief Summary

This study aims at determining clinical presentations and outcomes of patients with covid-19 pneumonia and also follow up of patients for up to 6 months to detect possibility of post covid fibrosis

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nasopharyngeal swap for Reverse transcription polymerase chain reaction

Detailed Description

According to the World Health Organization (WHO), the emergence of viral diseases represents a serious public health risk. In the past two decades, several epidemics caused by viruses such as the severe acute respiratory syndrome coronavirus (SARS-CoV) from 2002 to 2003, and H1N1 influenza in 2009, and the Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012 have been described which have had a significant impact on global health. Since being declared a global pandemic by the WHO, SARS-CoV-2, the virus responsible for COVID-19 has spread to 223 countries with more than 178 million confirmed cases, and more than 3.8 million deaths reported worldwide. The U.S. experienced the highest number of SARS-CoV-2 infections and COVID-19 related deaths followed by Brazil and India.

In fact, COVID-19 was the third leading cause of death in the U.S. in 2020 after heart disease and cancer, with approximately 375,000 death reported . As of 22 June 2021, the Alpha(B.1.1.7) variant has spread to 170 countries, the Beta (B.1.351) variant has been reported in 119 countries, the Gamma (P.1) variant has been detected in 71 countries and the Delta variant(B.1.617.2) has spread to 85 countries around the world based on the weekly epidemiological update by the WHO . The WHO's current estimate of the global case fatality rate for COVID-19 is 2.2%. However, the case fatality rate is affected by factors that include age, underlying preexisting conditions, and severity of illness and significantly varies between countries.

The common clinical features of COVID-19 pneumonia in adults include fever, dry cough, sore throat, headache, fatigue, myalgia and breathlessness . The disease manifestations in the infected patients range from mild pneumonia (81%) to moderate pneumonia (hypoxia requiring hospitalization, 14%), and critical illness (leading to invasive mechanical ventilation, multiorgan dysfunction and possibly death, 5%). The risk of death depends on age, underlying comorbidities and severity of the disease, increasing up to 49% in critically ill patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Post covid fibrosis [Six month]

    Possibility of occurrence of post covid fibrosis by follow up of patients for up to 6 month

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥18 years old

  2. Patients with covid-19 pneumonia confirmed by:

Reverse transcription polymerase chain reaction Or pattern of covid-19 in computed tomography (CT) scan ( ground-glass opacity indicative of pneumonia on CT, opinion on consolidation, etc) with laboratory investigations

Exclusion Criteria:
  1. Patients not confirmed to be covid-19 with PCR or radiologically.

  2. Patients who are diagnosed as bacterial pneumonia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Director: Hamdy A Mohammadeen, Ass.prof, Sohag University
  • Study Chair: Mona T Hussen, Ass.prof, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ghada Mohamed Bahy, Chest resident, Sohag University
ClinicalTrials.gov Identifier:
NCT05092555
Other Study ID Numbers:
  • Soh-Med-21-10-24
First Posted:
Oct 25, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021