COVID-19 PneumoniaNCT05249803
"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19
An observational study of COVID-19 Pneumonia, run by FMH College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a… Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Patients with COVID-19 Pneumonia
- How many people
- 133 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Dec 2021
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Non-interventional retrospective cohort study of critically sick patients with COVID-19 pneumonia admitted in the Intensive Care Unit of Fatima Memorial hospital (FMH) in Lahore, Pakistan from March 2021 to August 2021 4.3. Sample Size \& Technique: Records of 133 patients admitted to the ICU of the Fatima memorial hospital, Lahore, were studied.
Who may be able to join
- Critically sick patients with COVID-19 Pneumonia
- All admitted ICU patients with a diagnosis of COVID-19 pneumonia
- Patients having positive reverse transcriptase PCR for COVID-19
- Patients with High-resolution computed tomography (HRCT) chest findings suggestive of COVID-related lung injury
- All patients above 16 years of age with both genders( males and females)
Who cannot join
- All patients with PCR negative with mild symptoms
- Patients with No signs of COVID-19 pneumonia on HRCT chest
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima Memorial Hospital College of Medicine & Dentistry
Lahore, Punjab Province, 54000
About this study
Official title: "Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19 Pneumonia Admitted in Intensive Care Unit of a Tertiary Care Hospital in Lahore, Pakistan": A Retrospective Cohort Study
COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a present-day pandemic.
Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.
Read the detailed description
Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.
Material \& Methods:
Study design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted from March 2021 to August 2021.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Patients with COVID-19 Pneumonia
- Keywords
- Comorbidities, Outcomes, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with COVID-19 PneumoniaCombination product
Patients were offered with usual care of COVID-19 in ICU and we did retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 pneumonia | These patients were admitted in ICU for management of Covid-19 pneumonia usual care was offered to all patients Receives: Combination Product: Patients with COVID-19 Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The primary endpoint of the study will be to assess the ICU mortality (in percentages% and Numbers) of critically sick patients with COVID-19 pneumonia admitted to the intensive care unit
Measured: 6 months
Secondary outcomes (1)
Comorbidities
we will assess various comorbidities in critically sick patients with COVID-19 pneumonia admitted to the intensive care unit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- FMH College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijaz Zeeshan Khan Chachar, FMH College of Medicine and Dentistry
- Investigators
- Aijaz Zeeshan K Chachar, MBBS,FCPS, Principal investigator, FMH College of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249803
- Sponsor's protocol ID
- FMH-27/12/2021-IRB-983
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All the record can be retrieved from medical record department of fatima memorial hospital Lahore
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19 Pneumonia Admitted in Intensive Care Unit of a Tertiary Care Hospital in Lahore, Pakistan": A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05249803
- Acronym / sponsor ID
- FMH-27/12/2021-IRB-983
- Conditions
- COVID-19 Pneumonia
- Keywords
- Comorbidities, Outcomes, Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- FMH College of Medicine and DentistryUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Feb 2022 (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.
COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a present-day pandemic.
Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.
Detailed description
Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.
Material \& Methods:
Study design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted from March 2021 to August 2021.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 pneumonia | – | Combination Product: Patients with COVID-19 PneumoniaThese patients were admitted in ICU for management of Covid-19 pneumonia usual care was offered to all patients |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-interventional retrospective cohort study of critically sick patients with COVID-19 pneumonia admitted in the Intensive Care Unit of Fatima Memorial hospital (FMH) in Lahore, Pakistan from March 2021 to August 2021 4.3. Sample Size \& Technique: Records of 133 patients admitted to the ICU of the Fatima memorial hospital, Lahore, were studied.
Key inclusion criteria (5 listed)
- Critically sick patients with COVID-19 Pneumonia
- All admitted ICU patients with a diagnosis of COVID-19 pneumonia
- Patients having positive reverse transcriptase PCR for COVID-19
- Patients with High-resolution computed tomography (HRCT) chest findings suggestive of COVID-related lung injury
- All patients above 16 years of age with both genders( males and females)
Key exclusion criteria (2 listed)
- All patients with PCR negative with mild symptoms
- Patients with No signs of COVID-19 pneumonia on HRCT chest
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 |
|---|---|---|
| Patients with COVID-19 PneumoniaPatients were offered with usual care of COVID-19 in ICU and we did retrospective study | Combination product | Patients with COVID-19 pneumonia |
Primary outcome
Mortality
Time frame: 6 months
The primary endpoint of the study will be to assess the ICU mortality (in percentages% and Numbers) of critically sick patients with COVID-19 pneumonia admitted to the intensive care unit
1 secondary outcome
Comorbidities
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Yes. All the record can be retrieved from medical record department of fatima memorial hospital Lahore
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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.
Aijaz Zeeshan K Chachar, MBBS,FCPS principal investigator
FMH College of Medicine & Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia, run by FMH College of Medicine and Dentistry at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 months). 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 22 Feb 2022.