Novel COVID-19, A National Analysis

Prevalence and Clinical Characteristics of Novel COVID-19 Cases at One Quarantine Hospital; a National Analysis

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Prevalence of COVID-19

Detailed Description

This study will be done at one quarantine hospital in Assiut, Egypt. After approval from our Institutional Ethics Committee, a written informed consent will be obtained from all patients or their legal representatives (if they are unable to provide consent) before enrollment in the study.

Study Design and Sample Size Calculation: 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. According to our records, 30-60 patients may be included.

Clinical Classification of COVID-19 patients according to the Egyptian Ministry of Health and Population:

• Mild Cases: The clinical symptoms are mild and no pneumonia manifestations can be found in imaging.
• Moderate Cases Patients have symptoms (such as fever and respiratory tract symptoms, etc.) and pneumonia manifestations can be seen in imaging.
• Severe Cases Adults who meet any of the following criteria: Respiratory rate< 30 breaths/min; Oxygen saturations < 93% at a rest state; Arterial partial pressure of oxygen (PaO2)/Fraction of inspired oxygen (FiO2) [P/F ratio] <300 mmHg; Patients with more than 50% lesions progression within 24 to 48 hours in lung imaging should be treated as severe cases.

Study Tools and Data Collection: All admitted patients to the hospital will be monitored carefully and observed for medical treatment, supportive measures, hemodynamic variables, and comorbid conditions.

• Demographic Data: including age, sex and occupation.
• History of travelling abroad and history of contact to confirmed cases (positive to SARS-CoV-2).
• Vital signs (heart rate, non-invasive blood pressure, respiratory rate, peripheral oxygen saturation) at admission, at day 3, and day 7.

• laboratory investigation:

  • Complete blood picture
  • CRP (C reactive protein)
  • Prothrombin time, concentration, and INR
  • Liver function (ALT, AST, bilirubin)
  • Kidney function (blood urea and serum creatinine)
  • Arterial blood gas (ABG): at admission, day1, day 3 and day 5.
  • D-Dimer and ferritin levels
  • HRCT chest (High resolution computed tomography) chest at admission and follow up at discharge.
• Follow up and outcome: (RT-PCR for SARS-CoV-2, CT chest, ABG).
• The need of invasive mechanical ventilation, the clinical outcome, the duration of ICU and hospital stay.
• Any complications

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patient Refusal
• Pregnancy
• patients stopped participation at anytime

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Prognosis Score	The prognosis of COVID-19 patients at one quarantine hospital delivered to home, prolonged hospital stay, death.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation	Non-invasive peripheral oxygen saturation (%)	14 days
Laboratory Data	Complete blood picture	14 days
Radiological Features	High resolution computed tomography chest at admission and follow up at discharge	1 month
Hospital Stay	Duration of patients stay at hospital	1 month
Liver Function	Complete liver function tests	1 month
Kidney Function	Complete liver function tests	1 month

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohamed F. Mostafa, MD, membership/educator

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Novel COVID-19 Prevalence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No