NCT06022198

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 31, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

Bronchoalveolar lavageCOVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (1)

Recovered From COVID-19 Pneumonia

EXPERIMENTAL

Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia

Procedure: Bronchoalveolar Lavage

Interventions

Bronchoalveolar Lavage

Recovered From COVID-19 Pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Marwa Ghanem

    Mansoura university Faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 1, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations