Clinical trial NCT04792021: Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients
Official title: Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Corona Virus Disease 19 (Covid19)
Corona Virus Infection
Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)
Keywords: N-acetylcysteine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2021-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.

One arm is the intervention arm: those receiving N-acetylcysteine (NAC). One arm is the control group : those not receiving N-acetylcysteine (NAC).
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.

Detailed description: This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows:

1. Markers of inflammation and oxidative stress
2. Length of hospital stay
3. Need for ventilation
4. Mortality rate

Eligibility criteria: Inclusion Criteria:

1. Adults aged more than 18 years
2. Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included

Exclusion Criteria:

1. Known allergy or hypersensitivity to NAC
2. Pregnancy
3. Critically ill or mechanically ventilated patients

Primary outcomes:
measure: Change in TNF alfa level from baseline
timeFrame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
Secondary outcomes:
measure: Change in IL-6 level from baseline
timeFrame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
measure: Change in glutathione peroxidase level from baseline
timeFrame: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
measure: Length of hospital stay
timeFrame: Through study completion ( average 9 months)
measure: Need for mechanical ventilation
timeFrame: Through study completion ( average 9 months)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Assema Hospital
Study officials:
affiliation: Misr International University
name: Sara M. Sherkawy, B.S.P
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Lamia El Wakeel, Professor
role: STUDY_CHAIR
affiliation: Misr International University
name: Mona Schaalan, Professor
role: STUDY_DIRECTOR
affiliation: El Kasr El Einy Hospital
name: Ayman Moharram, Professor
role: STUDY_DIRECTOR
References: