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Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

Primary Purpose

Bronchoalveolar Lavage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bronchoalveolar Lavage
Sponsored by
Mohamed Abd Elmoniem Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchoalveolar Lavage focused on measuring Bronchoalveolar lavage, COVID-19 Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with persistent pulmonary infiltrate one month after discharge from isolation building at Mansoura university hospitals, previously tested positive for SARS-CoV-2 infection by real-time PCR on nasopharyngeal swab during admission, discharged and discontinued transmission based precautions according to CDC guidance: Symptom-Based Strategy for Discontinuing Transmission-Based Precautions (CDC, 2020) Patients with mild to moderate illness who are not severely immunocompromised: At least 10 days have passed since symptoms first appeared and At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g., cough, shortness of breath) have improved Patients with severe to critical illness or who are severely immunocompromised1: At least 10 days and up to 20 days have passed since symptoms first appeared and At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g., cough, shortness of breath) have improved Consider consultation with infection control experts Exclusion Criteria: Age: patients less than 18 years old. Patient refuse to undergo bronchoscopy. Patients unfit for bronchoscopy (hemodynamic instability, recent myocardial infarction, severe hypoxia, uncooperative patient, severe bleeding disorder). Patients known to have chronic airway pulmonary diseases or interstitial lung diseases

Sites / Locations

  • Mohamed AbdElmoniem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recovered From COVID-19 Pneumonia

Arm Description

Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

Outcomes

Primary Outcome Measures

evaluate BAL in post-acute COVID-19 patients
Understanding the pathophysiological mechanisms of COVID-19 and nature of the immunological defense in lungs in response to viral infection by SARS-CoV2 is essential in order to initiate timely and targeted anti-inflammatory, anticoagulative, or even antifibrotic therapy

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Mohamed Abd Elmoniem Mohamed
Collaborators
Marwa Salah Abdelrazek Ghanem, Mohammad Khairy El-Badrawy, Tamer Ali Elhadidy, Dalia Abdellateif Abdelghany
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1. Study Identification

Unique Protocol Identification Number
NCT06022198
Brief Title
Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia
Official Title
Study of Bronchoalveolar Lavage in Patients Recovered From COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Abd Elmoniem Mohamed
Collaborators
Marwa Salah Abdelrazek Ghanem, Mohammad Khairy El-Badrawy, Tamer Ali Elhadidy, Dalia Abdellateif Abdelghany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and mortality in infected persons. Lung is the most common site of infection for these viruses, which may manifest as acute respiratory distress syndrome and mortality. Pulmonary involvement is also responsible for the high viral transmission The aim of this study is to evaluate BAL in post-acute COVID-19 patients for:Cytological and cellular patterns. Microbial analysis for possibility of presence of bacterial, mycobacerial or fungal co-infection.PCR for corona virus
Detailed Description
On December 31, 2019, a cluster of cases of pneumonia in people who were later linked to Wuhan Seafood Market in Wuhan, Hubei, China, were reported. Just a week later, Chinese health authorities confirmed that those cases were caused by a novel coronavirus, later named as SARS-CoV2 . Till date, six coronavirus species are known to cause human diseases. Four of the already-known coronavirus species, i.e., 229E, OC43, NL63, and HKU1, are commonly circulating viruses in human population and cause mild common cold-like symptoms. Two of the already-known strains of coronavirus, severe acute respiratory syndrome-coronavirus (SARS-CoV) and Middle East respiratory syndrome-CoV (MERS-CoV) are zoonotic in origin and cause serious illnesses which can be fatal. Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and mortality in infected persons. Lung is the most common site of infection for these viruses, which may manifest as acute respiratory distress syndrome and mortality. Pulmonary involvement is also responsible for the high viral transmission. BAL, bronchial wash, and protected specimen brush are bronchoscopic procedures used to provide microbiological samples from lower respiratory airways. However, because of the risk of viral transmission, bronchoscopy is not routinely indicated for the diagnosis of COVID-19. Even if SARS-CoV-2 shares similarities with the other coronaviruses, the higher diffusion rate and the possibility to induce fatal complications, such as severe pneumonia, acute respiratory distress syndrome (ARDS), thrombosis, septic shock and organ failure, make this virus a major public health threat. Since the first guidelines for autopsy on both confirmed and suspected COVID-19-positive patients were published in February 2020, an increasing number of biopsies and autopsies have been performed. However, our knowledge regarding the precise nature of the immunological defense in various organ systems in response to viral infection, as well as the response patterns in specific tissues, is largely incomplete but is essential in order to initiate timely and targeted antiviral, anti-inflammatory, anticoagulative, or even antifibrotic therapy . As of yet, most research papers have focused on the inflammatory status at the plasma level of COVID-19 patients. However, because the main target organ is the lung, it is crucial to understand the inflammatory status at the deep lung level during different stages of the infection. Currently, limited data are available about alveolar inflammatory status in COVID-19 patients because of concerns in relation to using bronchoscopy to avoid aerosol generation. The aim of this study is to evaluate BAL in post-acute COVID-19 patients for:Cytological and cellular patterns. Microbial analysis for possibility of presence of bacterial, mycobacerial or fungal co-infection.PCR for corona virus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchoalveolar Lavage
Keywords
Bronchoalveolar lavage, COVID-19 Pneumonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective cross sectional study at which COVID-19 patients with persistent pulmonary infiltrate one month after discharge from isolation department at Mansoura university hospitals will be enrolled in the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovered From COVID-19 Pneumonia
Arm Type
Experimental
Arm Description
Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia
Intervention Type
Procedure
Intervention Name(s)
Bronchoalveolar Lavage
Intervention Description
Bronchoalveolar Lavage
Primary Outcome Measure Information:
Title
evaluate BAL in post-acute COVID-19 patients
Description
Understanding the pathophysiological mechanisms of COVID-19 and nature of the immunological defense in lungs in response to viral infection by SARS-CoV2 is essential in order to initiate timely and targeted anti-inflammatory, anticoagulative, or even antifibrotic therapy
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with persistent pulmonary infiltrate one month after discharge from isolation building at Mansoura university hospitals, previously tested positive for SARS-CoV-2 infection by real-time PCR on nasopharyngeal swab during admission, discharged and discontinued transmission based precautions according to CDC guidance: Symptom-Based Strategy for Discontinuing Transmission-Based Precautions (CDC, 2020) Patients with mild to moderate illness who are not severely immunocompromised: At least 10 days have passed since symptoms first appeared and At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g., cough, shortness of breath) have improved Patients with severe to critical illness or who are severely immunocompromised1: At least 10 days and up to 20 days have passed since symptoms first appeared and At least 24 hours have passed since last fever without the use of fever-reducing medications and Symptoms (e.g., cough, shortness of breath) have improved Consider consultation with infection control experts Exclusion Criteria: Age: patients less than 18 years old. Patient refuse to undergo bronchoscopy. Patients unfit for bronchoscopy (hemodynamic instability, recent myocardial infarction, severe hypoxia, uncooperative patient, severe bleeding disorder). Patients known to have chronic airway pulmonary diseases or interstitial lung diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Ghanem
Organizational Affiliation
Mansoura university Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed AbdElmoniem
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

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