COVID-19 trials registries data warehouse

 Return to trial list

Trial - IRCT20200509047364N3


Column Value
Trial registration number IRCT20200509047364N3
Full text link
Last imported at : Feb. 21, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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"}]