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Completed

NCT Number: NCT05504655

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

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.

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Key information

Conditions

COVID-19 Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The necessity for invasive mechanical ventilation

    Time frame: 3 to 4 months

    Primary outcome

Secondary outcomes

  1. The onset and duration of invasive mechanical ventilation, length of ICU stay, length of hospital stay and 28 days mortality

    Time frame: 3 to 4 months

    Secondary outcomes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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