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

NCT05504655 | Completed

• 1 other identifier: FMASU 129/2022. FWA 000017585
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• The necessity for invasive mechanical ventilation

  Primary outcome

  3 to 4 months

Secondary Outcomes (1)

• 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 Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: November 27, 2022
• Study Completion: December 22, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)