Back to resultsEffect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- Universitas Sebelas Maret Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
N-acetylcysteine injection 1200 mg
N-acetylcysteine pill 1200 mg
N-acetylcysteine pills 600 mg per day
placebo
Arm Description
N-acetylcysteine injection 1200 mg per day
N-acetylcysteine pill 1200 mg orally per day
N-acetylcysteine pills 600 mg per day orally
Capsule with shape and appearance similar to N-acetylcysteine
Outcomes
Primary Outcome Measures
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte ratio
Length of stay
Length of stay
Secondary Outcome Measures
Full Information
NCT ID
NCT05658549
First Posted
November 26, 2022
Last Updated
December 17, 2022
Sponsor
Universitas Sebelas Maret
1. Study Identification
Unique Protocol Identification Number
NCT05658549
Brief Title
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Official Title
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine injection 1200 mg
Arm Type
Experimental
Arm Description
N-acetylcysteine injection 1200 mg per day
Arm Title
N-acetylcysteine pill 1200 mg
Arm Type
Experimental
Arm Description
N-acetylcysteine pill 1200 mg orally per day
Arm Title
N-acetylcysteine pills 600 mg per day
Arm Type
Experimental
Arm Description
N-acetylcysteine pills 600 mg per day orally
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Capsule with shape and appearance similar to N-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
N-acetyl cysteine dosage 600 mg and 1200 mg
Primary Outcome Measure Information:
Title
Neutrophil to lymphocyte ratio
Description
Neutrophil to lymphocyte ratio
Time Frame
Change of Neutrophil to lymphocyte ratio at 7 day
Title
Length of stay
Description
Length of stay
Time Frame
From date of randomization until the date of return from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitas Sebelas Maret Hospital
City
Sukoharjo
State/Province
Central Java
ZIP/Postal Code
57161
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
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