COVID-19 PneumoniaNCT05092555
Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia
An observational study of COVID-19 Pneumonia, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Nasopharyngeal swap for Reverse transcription polymerase chain reaction
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with covid-19 pneumonia
Who may be able to join
- Age ≥18 years old
- 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
Who cannot join
- Patients not confirmed to be covid-19 with PCR or radiologically.
- Patients who are diagnosed as bacterial pneumonia.
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Nasopharyngeal swap for Reverse transcription polymerase chain reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swap for Reverse transcription polymerase chain reactionDiagnostic test
Also called CT chest d-dimer C-reactive protein serum ferritin
Nasopharyngeal swap and Blood sample is taken for doing previous tests and CT chest is done for all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Post covid fibrosis
Possibility of occurrence of post covid fibrosis by follow up of patients for up to 6 month
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Bahy, Sohag University
- Investigators
- Hamdy A Mohammadeen, Ass.prof, Study director, Sohag UniversityMona T Hussen, Ass.prof, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092555
- Sponsor's protocol ID
- Soh-Med-21-10-24
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05092555
- Acronym / sponsor ID
- Soh-Med-21-10-24
- Conditions
- COVID-19 Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with covid-19 pneumonia
Key inclusion criteria (3 listed)
- Age ≥18 years old
- 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
Key exclusion criteria (2 listed)
- Patients not confirmed to be covid-19 with PCR or radiologically.
- Patients who are diagnosed as bacterial pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal swap for Reverse transcription polymerase chain reactionAlso: CT chest d-dimer C-reactive protein serum ferritinNasopharyngeal swap and Blood sample is taken for doing previous tests and CT chest is done for all patients | Diagnostic test | – |
Primary outcome
Post covid fibrosis
Time frame: Six month
Possibility of occurrence of post covid fibrosis by follow up of patients for up to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdy A Mohammadeen, Ass.prof study director
Sohag University
Mona T Hussen, Ass.prof study chair
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada M Bahy (+201063551135, ghadabahy567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post covid fibrosis (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.