N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Egypt
  • Ain Shams University Specialized Hospital
    • Cairo, Ain Shams University Specialized Hospital, Egypt
      • Hanaa El Gendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older of both genders diagnosed with confirmed critically ill COVID-19

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Observational NAC group; Based on a FDA approved 3-bag regime, NAC (Molecular weight:163) was administrated intravenously, initially 150 mg/kg in 200 mL of 0.9%NaCL for 60 minutes (first bag), followed by 50 mg/kg in 500 mL of 0.9%NaCL for 4 hours (second bag), and then 100 mg/kg in 1000 mL of 0.9%NaCL for 16 hours (third bag)
Observational Non NAC group; N-acetylcysteine given IV at 600 mg every 12 hours till discharge from ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The necessity for invasive mechanical ventilation	Primary outcome	3 to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset and duration of invasive mechanical ventilation, length of ICU stay, length of hospital stay and 28 days mortality	Secondary outcomes	3 to 4 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ACTUAL): November 27, 2022
• Study Completion (ACTUAL): December 22, 2022

Study Registration Dates

• First Submitted: August 13, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FMASU 129/2022. FWA 000017585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No