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

NCT ID: NCT05658549

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-07-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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N-acetylcysteine injection 1200 mg

N-acetylcysteine injection 1200 mg per day

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine dosage 600 mg and 1200 mg

N-acetylcysteine pill 1200 mg

N-acetylcysteine pill 1200 mg orally per day

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine dosage 600 mg and 1200 mg

N-acetylcysteine pills 600 mg per day

N-acetylcysteine pills 600 mg per day orally

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine dosage 600 mg and 1200 mg

placebo

Capsule with shape and appearance similar to N-acetylcysteine

Group Type PLACEBO_COMPARATOR

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine dosage 600 mg and 1200 mg

Interventions

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N-acetyl cysteine

N-acetyl cysteine dosage 600 mg and 1200 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Sebelas Maret

OTHER

Sponsor Role lead

Responsible Party

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Nurhasan Agung Prabowo

Head of Hospital Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitas Sebelas Maret Hospital

Sukoharjo, Central Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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NAP02

Identifier Type: -

Identifier Source: org_study_id