Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: N-acetyl cysteine

• Registration Number: NCT05658549
• Lead Sponsor: Universitas Sebelas Maret

Brief Summary

This research is a study that compares the administration of N-acetylcysteine at various doses with the outcomes of COVID-19 patients, namely the neutrophil-to-lymphocyte ratio and length of stay.

Detailed Description

This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into four groups. The control group K0 received standard therapy without NAC, while the treatment group K1 received NAC injections of 1200mg/day, K2 NAC tablets 3x400mg/day, and K3 NAC tablets 3x200mg/day. Different tests using Way ANOVA and LSD or Kruskal-Wallis and Mann-Whitney.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Study First Submitted: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• moderate or severe grade confirmed COVID-19 (patients with symptoms and radiological examination showing pneumonia with or without signs of severe pneumonia: SpO2<90%, respiratory rate>30x/min, and severe respiratory distress) who were admitted to UNS Hospital and age 18-60 years old

Exclusion Criteria

• patients who died during the treatment period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine pills 600 mg per day	N-acetyl cysteine	N-acetylcysteine pills 600 mg per day orally
N-acetylcysteine injection 1200 mg	N-acetyl cysteine	N-acetylcysteine injection 1200 mg per day
N-acetylcysteine pill 1200 mg	N-acetyl cysteine	N-acetylcysteine pill 1200 mg orally per day
placebo	N-acetyl cysteine	Capsule with shape and appearance similar to N-acetylcysteine

Primary Outcome Measures

Name	Time	Method
Neutrophil to lymphocyte ratio	Change of Neutrophil to lymphocyte ratio at 7 day	Neutrophil to lymphocyte ratio
Length of stay	From date of randomization until the date of return from hospital	Length of stay

Trial Locations

Locations (1)

Universitas Sebelas Maret Hospital; 🇮🇩 Sukoharjo, Central Java, Indonesia