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

• Sponsor: Universitas Sebelas Maret (Other)
• Overall Status: Completed
• CT.gov ID: NCT05658549
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Actual Duration (Months): 3
• Patients Per Site Per Month: 40.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: N-acetyl cysteine	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This study used N acetyl cysteine capsules and placebo, which were made similar in shape; researchers and patients did not know who was getting the drug or placebo.
• Primary Purpose: Treatment
• Official Title: Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: Jul 30, 2021
• Actual Study Completion Date: Jul 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Neutrophil to lymphocyte ratio [Change of Neutrophil to lymphocyte ratio at 7 day]

   Neutrophil to lymphocyte ratio

2. Length of stay [From date of randomization until the date of return from hospital]

   Length of stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitas Sebelas Maret Hospital	Sukoharjo	Central Java	Indonesia	57161

Sponsors and Collaborators

• Universitas Sebelas Maret

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nurhasan Agung Prabowo, Head of Hospital Research Unit, Universitas Sebelas Maret
• ClinicalTrials.gov Identifier: NCT05658549
• Other Study ID Numbers: NAP02
• First Posted: Dec 20, 2022
• Last Update Posted: Dec 20, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Dec 20, 2022