COVID-19Phase 1/2NCT05658549
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
A Phase 1/2 study testing N-acetyl cysteine in people with COVID-19, run by Universitas Sebelas Maret at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2021to 30 Jul 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- patients who died during the treatment period
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- N-acetyl cysteine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
N-acetyl cysteine dosage 600 mg and 1200 mg
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine injection 1200 mg | Experimental | N-acetylcysteine injection 1200 mg per day Receives: Drug: N-acetyl cysteine |
| N-acetylcysteine pill 1200 mg | Experimental | N-acetylcysteine pill 1200 mg orally per day Receives: Drug: N-acetyl cysteine |
| N-acetylcysteine pills 600 mg per day | Experimental | N-acetylcysteine pills 600 mg per day orally Receives: Drug: N-acetyl cysteine |
| placebo | Placebo comparator | Capsule with shape and appearance similar to N-acetylcysteine Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to lymphocyte ratio
Neutrophil to lymphocyte ratio
Measured: Change of Neutrophil to lymphocyte ratio at 7 day
Length of stay
Length of stay
Measured: From date of randomization until the date of return from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 May 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658549
- Sponsor's protocol ID
- NAP02
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05658549
- Acronym / sponsor ID
- NAP02
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine injection 1200 mg | Experimental | Drug: N-acetyl cysteineN-acetylcysteine injection 1200 mg per day |
| N-acetylcysteine pill 1200 mg | Experimental | Drug: N-acetyl cysteineN-acetylcysteine pill 1200 mg orally per day |
| N-acetylcysteine pills 600 mg per day | Experimental | Drug: N-acetyl cysteineN-acetylcysteine pills 600 mg per day orally |
| placebo | Placebo comparator | Drug: N-acetyl cysteineCapsule with shape and appearance similar to N-acetylcysteine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients who died during the treatment period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineN-acetyl cysteine dosage 600 mg and 1200 mg | Drug | N-acetylcysteine injection 1200 mg, N-acetylcysteine pill 1200 mg, N-acetylcysteine pills 600 mg per day, placebo |
Primary outcome
Neutrophil to lymphocyte ratio
Time frame: Change of Neutrophil to lymphocyte ratio at 7 day
Neutrophil to lymphocyte ratio
Length of stay
Time frame: From date of randomization until the date of return from hospital
Length of stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-acetyl cysteine in people with COVID-19, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil to lymphocyte ratio (time frame: Change of Neutrophil to lymphocyte ratio at 7 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.