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

December 17, 2022 updated by: Nurhasan Agung Prabowo, Universitas Sebelas Maret
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Sukoharjo, Central Java, Indonesia, 57161
        • Universitas Sebelas Maret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-acetylcysteine injection 1200 mg
N-acetylcysteine injection 1200 mg per day
Drug: N-acetyl cysteine
N-acetyl cysteine dosage 600 mg and 1200 mg
Experimental: N-acetylcysteine pill 1200 mg
N-acetylcysteine pill 1200 mg orally per day
Drug: N-acetyl cysteine
N-acetyl cysteine dosage 600 mg and 1200 mg
Experimental: N-acetylcysteine pills 600 mg per day
N-acetylcysteine pills 600 mg per day orally
Drug: N-acetyl cysteine
N-acetyl cysteine dosage 600 mg and 1200 mg
Placebo Comparator: placebo
Capsule with shape and appearance similar to N-acetylcysteine
Drug: N-acetyl cysteine
N-acetyl cysteine dosage 600 mg and 1200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil to lymphocyte ratio
Time Frame: Change of Neutrophil to lymphocyte ratio at 7 day
Neutrophil to lymphocyte ratio
Change of Neutrophil to lymphocyte ratio at 7 day
Length of stay
Time Frame: From date of randomization until the date of return from hospital
Length of stay
From date of randomization until the date of return from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 17, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAP02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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