Effect of N-acetylcysteine on Oxidative Stress in COVID-19 Patients

NCT04792021 | Completed Phase 3

• 1 other identifier: N-acetylcysteine in COVID 19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corona Virus Disease 19 (Covid19); Corona Virus Infection; Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV2)

Keywords

N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Change in TNF alfa level from baseline

  The mean change in TNF alfa is used to assess NAC efficacy

  from enrollment till the end of treatment at 2 weeks or until hospital discharge or death

Secondary Outcomes (4)

• Change in IL-6 level from baseline

  from enrollment till the end of treatment at 2 weeks or until hospital discharge or death

• Change in glutathione peroxidase level from baseline

  from enrollment till the end of treatment at 2 weeks or until hospital discharge or death

• Length of hospital stay

  Through study completion ( average 9 months)

• Need for mechanical ventilation

  Through study completion ( average 9 months)

Study Arms (2)

N-acetylcysteine (NAC)

ACTIVE COMPARATOR

Patients receiving N-acetylcysteine (NAC)

Drug: N-acetylcysteine

Control

NO INTERVENTION

Patients not receiving N-acetylcysteine (NAC)

Interventions

N-acetylcysteine DRUG

Oral formulation: 600 mg sachets of N-acetylcysteine

Also known as: Acetylcysteine

N-acetylcysteine (NAC)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Known allergy or hypersensitivity to NAC
• Pregnancy
• Critically ill or mechanically ventilated patients

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator

Study Sites (1)

Al Assema Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sara M. Sherkawy, B.S.P

  Misr International University

  PRINCIPAL INVESTIGATOR

• Lamia El Wakeel, Professor

  Ain Shams University

  STUDY CHAIR

• Mona Schaalan, Professor

  Misr International University

  STUDY DIRECTOR

• Ayman Moharram, Professor

  El Kasr El Einy Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator at the Faculty of pharmacy

Model Details: 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).

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 10, 2021
• Study Start: March 9, 2021
• Primary Completion: September 13, 2021
• Study Completion: April 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

EG (1)