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

NCT05658549 | Completed Phase 1 DMC

• 1 other identifier: NAP02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Neutrophil to lymphocyte ratio

  Neutrophil to lymphocyte ratio

  Change of Neutrophil to lymphocyte ratio at 7 day

• Length of stay

  Length of stay

  From date of randomization until the date of return from hospital

Study Arms (4)

N-acetylcysteine injection 1200 mg

EXPERIMENTAL

N-acetylcysteine injection 1200 mg per day

Drug: N-acetyl cysteine

N-acetylcysteine pill 1200 mg

EXPERIMENTAL

N-acetylcysteine pill 1200 mg orally per day

Drug: N-acetyl cysteine

N-acetylcysteine pills 600 mg per day

EXPERIMENTAL

N-acetylcysteine pills 600 mg per day orally

Drug: N-acetyl cysteine

placebo

PLACEBO COMPARATOR

Capsule with shape and appearance similar to N-acetylcysteine

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteine DRUG

N-acetyl cysteine dosage 600 mg and 1200 mg

N-acetylcysteine injection 1200 mg; N-acetylcysteine pill 1200 mg; N-acetylcysteine pills 600 mg per day; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patients who died during the treatment period

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Universitas Sebelas Maret Hospital

Sukoharjo, Central Java, 57161, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hospital Research Unit

Model Details: 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 Record Dates

• First Submitted: November 26, 2022
• First Posted: December 20, 2022
• Study Start: May 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)