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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05658549
Other study ID # NAP02
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 1, 2021
Est. completion date July 30, 2021

Study information

Verified date December 2022
Source Universitas Sebelas Maret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
N-acetyl cysteine
N-acetyl cysteine dosage 600 mg and 1200 mg

Locations

Country Name City State
Indonesia Universitas Sebelas Maret Hospital Sukoharjo Central Java

Sponsors (1)

Lead Sponsor Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neutrophil to lymphocyte ratio Neutrophil to lymphocyte ratio Change of Neutrophil to lymphocyte ratio at 7 day
Primary Length of stay Length of stay From date of randomization until the date of return from hospital
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