Trial registration number
|
IRCT20200509047364N3 |
Full text link
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/54372
|
First author
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Dr. Teamur Aghamolaei
|
Contact
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
research@hums.ac.ir
|
Registration date
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-02-20
|
Recruitment status
Last imported at : April 1, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
single-center
|
Study aim
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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 <300), pulmonary infiltration (> 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
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Known allergy or hypersensitivity to N-Acetylcysteine.
Pregnancy
The participant refused to participate in the continuation of the study.
|
Number of arms
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Bandare-abbas University of Medical Sciences
|
Inclusion age min
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
0
|
Inclusion age max
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Severe/critical disease at enrollment
|
Severity scale
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
7: Severe/critical disease at enrollment
|
Total sample size
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
|
primary outcome
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patient's clinical condition
Length of Intensive Care Unit admission
|
Notes
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 850, "treatment_name": "N-acetylcysteine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
|