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Clinical Trials/NCT05504655
NCT05504655
Completed
Not Applicable

Safety and Efficacy of N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients: A Retrospective Observational Study

Ain Shams University1 site in 1 country80 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Pneumonia
Sponsor
Ain Shams University
Enrollment
80
Locations
1
Primary Endpoint
The necessity for invasive mechanical ventilation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In this study, we retrospectively will investigate safety and efficacy of NAC dose given in paracetamol toxicity as an adjuvant therapy in critically ill COVID-19 patients with acute respiratory distress and determine whether NAC in high doses can avoid respiratory failure in patients with COVID-19.

Detailed Description

Type of Study:Retrospective Observational Cohort Study. Study Setting: Ain shams university hospitals . Study Period: from December 2020 to February 2022 Study Population:Patients aged 18 years or older of both genders diagnosed with confirmed critically ill COVID-19 . This is a retrospective observational study in which all cases will be collected from ICU of Ain shams university hospitals during COVID-19 outbreak. All data will be extracted from clinical records. All patients initially admitted to ICU with SPO2 less than 94 % will be included between December 2020 to February 2022. Infection with COVID-19 was confirmed by PCR. All patients received standard care, according to the institutional protocol. Laboratory and Radiological Investigations Demographic, clinical, laboratory, management, and outcome data will be obtained from the medical records. Routine laboratory tests were done for all patients, including CBC, C-reactive protein, renal profile, coagulation profile, liver profile, lactate, electrolytes, procalcitonin, ferritin and D-dimer.Infection with COVID-19 was confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab. Chest computed tomography (CT) was also done for all patients.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
December 22, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hanaa Mohamed Abdallah ElGendy MD

Professor

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Oxyhemoglobin saturation (SaO2) of less than 94% while breathing ambient air

Exclusion Criteria

  • Need for immediate mechanical ventilation on admission, known allergy or hypersensitivity to NAC, end stage renal and liver diseases, heart failure and pregnancy.

Outcomes

Primary Outcomes

The necessity for invasive mechanical ventilation

Time Frame: 3 to 4 months

Primary outcome

Secondary Outcomes

  • The onset and duration of invasive mechanical ventilation, length of ICU stay, length of hospital stay and 28 days mortality(3 to 4 months)

Study Sites (1)

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