NCT04413045

Brief Summary

Pneumonia is a form of acute respiratory tract infection (ARTI) that affects the lungs. When an individual has pneumonia, the alveoli in the lungs are filled with pus and fluid, which makes breathing painful and limits oxygen intake. Pneumonia has many possible causes, but the most common are bacteria and viruses but nowadays there is a pandemic spread from novel corona virus which cause corona virus disease 2019 (COVID-19). Corona virus comprises of a large family of viruses that are common in human beings as well animals (camels, cattle, cats, and bats). There are seven different strains of corona virus. Sometimes corona virus from animals infect people and spread further via human to human transmission such as with MERS-CoV, SARS-CoV, and now with this COVID-19 (Corona disease 2019). The virus that causes COVID-19 is designated as severe acute respiratory syndrome corona virus 2 (SARS-CoV-2); previously, referred to as 2019-nCoV. On Towards December 2019, this novel corona virus was identified as a cause of upper and lower respiratory tract infections in Wuhan, a city in the Hubei Province of China. It rapidly spread, resulting in an epidemic throughout China and then gradually spreading to other parts of the world in pandemic proportions. It has affected almost every continent in this world. In February 2020, the World Health Organization designated the disease COVID-19, which stands for corona virus disease 2019. The Coronaviruses are a large family of single-stranded RNA viruses (+ssRNA) that can be isolated in different animal species. They have a crown-like appearance under an electron microscope (coronam is the Latin term for crown) due to the presence of spike glycoproteins on the envelope. These viruses can also infect humans and cause illness ranging from the common cold to more severe diseases such as MERS, SARS and now COVID-19. According to recent research, a spike mutation, which probably occurred in late November 2019, triggered jumping to humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

June 1, 2020

Last Update Submit

August 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Prognosis Score

    The prognosis of COVID-19 patients at one quarantine hospital delivered to home, prolonged hospital stay, death.

    1 month

Secondary Outcomes (6)

  • Oxygen Saturation

    14 days

  • Laboratory Data

    14 days

  • Radiological Features

    1 month

  • Hospital Stay

    1 month

  • Liver Function

    1 month

  • +1 more secondary outcomes

Study Arms (1)

C Group

All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.

Other: Prevalence of COVID-19

Interventions

All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.

C Group

Eligibility Criteria

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

This study is an investigator-initiated cross sectional trial to record, assess the clinical manifestations and prognosis of all COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration. The study aims To detect epidemiology, clinical and radiological presentation, laboratory findings, complications, duration needed to conversion from positive to negative PCR, duration of hospital stay and outcome of COVID-19 patients admitted in one quarantine hospital

You may qualify if:

  • Any Age
  • Any Sex
  • non pregnant women
  • RT-PCR positive for SARS-CoV-2

You may not qualify if:

  • Patient Refusal
  • Pregnancy
  • patients stopped participation at anytime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mohamed F. Mostafa, MD

    membership/educator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 2, 2020

Study Start

May 20, 2020

Primary Completion

July 28, 2020

Study Completion

July 28, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations