Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

Sponsor
Mohamed Abd Elmoniem Mohamed (Other)
Overall Status
Completed
CT.gov ID
NCT06022198
Collaborator
Marwa Salah Abdelrazek Ghanem (Other), Mohammad Khairy El-Badrawy (Other), Tamer Ali Elhadidy (Other), Dalia Abdellateif Abdelghany (Other)
50
1
1
24
2.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bronchoalveolar Lavage
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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 studyprospective 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)
Primary Purpose:
Diagnostic
Official Title:
Study of Bronchoalveolar Lavage in Patients Recovered From COVID-19 Pneumonia
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recovered From COVID-19 Pneumonia

Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

Procedure: Bronchoalveolar Lavage
Bronchoalveolar Lavage

Outcome Measures

Primary Outcome Measures

  1. evaluate BAL in post-acute COVID-19 patients [Baseline]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mohamed AbdElmoniem Mansoura Egypt 35516

Sponsors and Collaborators

  • Mohamed Abd Elmoniem Mohamed
  • Marwa Salah Abdelrazek Ghanem
  • Mohammad Khairy El-Badrawy
  • Tamer Ali Elhadidy
  • Dalia Abdellateif Abdelghany

Investigators

  • Principal Investigator: Marwa Ghanem, Mansoura university Faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Abd Elmoniem Mohamed, Assistant lecturer, Mansoura University Hospital
ClinicalTrials.gov Identifier:
NCT06022198
Other Study ID Numbers:
  • MD.21.01.408
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Abd Elmoniem Mohamed, Assistant lecturer, Mansoura University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023