The effect of N-Acetylcysteine on COVID-19

Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200509047364N3

Enrollment

Registered

2021-02-20

Start date

2021-03-02

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laboratory confirmed COVID-19. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: Group A receives standard drug therapy based on the treatment protocols of the National Committee COVID-19 and N-Acetylcysteine (Exi-Nac 2g/10ml AMP (EXIR pharmaceu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All COVID-19 patients whose disease has been confirmed by the PCR test for SARS-Cov-2. Having one of the criteria for severe COVID-19 disease includes tachypnea (respiration rate> 30 per minute), hypoxemia (O2 = saturation, arterial oxygen partial pressure ratio 50% of lung area during 24 48 h), LDH> 245 U / l, Progressive lymphopenia. Hospitalized in the intensive care unit. Signing the written consent of the study participant.

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to N-Acetylcysteine. Pregnancy The participant refused to participate in the continuation of the study.

Design outcomes

Primary

Measure	Time frame
Patient's clinical condition. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Clinical examinations.;Length of Intensive Care Unit admission. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Record patient information.	—

Measure

Time frame

Patient's clinical condition. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Clinical examinations.;Length of Intensive Care Unit admission. Timepoint: At the time of admission to the hospital (Before starting the intervention) and on the 14th day of hospitalization or the day of discharge. Method of measurement: Record patient information.

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Secondary

Measure	Time frame
Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.;Oxygen saturation state. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.;Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Chest X-ray.;Lactate Dehydrogenase(LDH) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;C-reactive protein(CRP) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;Platelet count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.	—

Measure

Time frame

Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.;Oxygen saturation state. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.;Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Chest X-ray.;Lactate Dehydrogenase(LDH) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;C-reactive protein(CRP) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.;Platelet count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDariush Hooshyar

Bandare-abbas University of Medical Sciences

dariush.hooshyar@gmail.com+98 990 038 7226

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 23, 2026