Clinical Trials Logo

Clinical Trial Summary

Background: CT has been used on a massive scale to help identify and investigate suspected or confirmed cases of COVID-19 pneumonia. This study aimed to assess the prognostic significance of the chest findings MSCT of Covid-19 patients and to determine if prognosis can rely on the initial CT imaging. Methods: The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection. The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (include; dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of the patients was classified into 4 groups; Group A: (mild cases), Group B: (moderate cases), Group C: (sever cases), and Group D: (fatality cases).


Clinical Trial Description

Patients and methods The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection during the period from April 2020 to December 2020. Inclusion criteria: • Patients who had positive RT-PCR test for COVID-19 infection and show positive chest CT findings. Exclusion criteria: - Patients with negative RT PCR test for COVID 19 infection. - Patients with positive RT PCR test for COVID 19 and negative chest CT findings. - Patients with other pre-existing lung pathologies in the chest CT. Data were collected from patients files included; history including symptoms and co-morbidities , and previously available examination data. Approval was taken from the ethics committee of researchers of Benha university. An informed consent was taken from all the participants. The consent contains: 1. Their approval that their studies and clinical data could be used for research purpose. 2. All patients' clinical data is considered confidential. 3. Signatures or fingerprints of the participants were taken. The picture archiving and communication systems (PACS) in both hospitals were revised during the period form the 1st of April 2020 to the 31st of December 2020. The included CT studies were revised first for technical appropriateness, and the studies with technical problems were excluded. All chest CT examinations were performed using multislice CT equipment (Toshiba Activion 16 and Toshiba Alexion 16). The exams were performed with patients in supine position and breath-hold during full expiration. The scanning range was from the lower neck down to the level of the adrenal glands. The scanning parameters were as follows: helical scanning mode; tube voltage, 120 kV; tube current-time product, 50-350 mAs; pitch, 1.2 and 1.375; matrix, 512 × 512; slice thickness, 5 mm; reconstructed in distribution lung window; reconstructed slice thickness, 1.25 mm. Followed by sagittal and coronal reconstruction. The technically accepted studies were extracted from the PACS system. They were interpreted by radiologists and pulmonologist (14 and 10 years in chest CT interpretation respectively) in blind manner. The following CT features were assessed: (peripheral, central, or central and peripheral), number of lobes involved (one, two or three, four or five), shape (patchy, nodular), appearance (ground-glass opacity [GGO], consolidation, or GGO with consolidation), specific signs within the lesions (vascular thickening, crazy paving pattern, air bronchogram sign, halo sign, and fibrosis), size of largest lesion (< 1 cm, 1-3 cm, > 3 cm), and extra-pulmonary manifestations (mediastinal and hilar lymph node enlargement, pleural effusion, pleural thickening). CT severity scoring was calculated for each case (2). The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of patients was classified into 4 groups, as follows: 1. Group A: (mild cases): with no progression of the respiratory symptoms. 2. Group B: (moderate cases): who have worsened disease but not requiring ICU admission. 3. Group C: (sever cases): patient who needed ICU admission. 4. Group D: (fatality cases): cases who died with or without ICU admission). Statistical Analysis Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 20. The qualitative data were presented as number and percentages while quantitative data were presented as mean, standard deviations and ranges when their distribution found parametric. The comparison between two groups with qualitative data were done by using Chi-square test and/or Fisher exact test which was used instead of Chi-square test when the expected count in any cell was found less than 5. The comparison between more than two independent groups with quantitative data and parametric distribution was done by using One Way ANOVA Test. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p-value was considered significant as the following: P> 0.05 = non-significant (NS), P < 0.05 = significant (S), P < 0.001 = highly significant (HS) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05235373
Study type Observational
Source Benha University
Contact
Status Completed
Phase
Start date April 1, 2020
Completion date October 15, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure