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Trial - IRCT20110510006431N6


Column Value
Trial registration number IRCT20110510006431N6
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Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Afshin Zarghi

Contact
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

azarghi@yahoo.com

Registration date
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-10-29

Recruitment status
Last imported at : May 22, 2023, 4 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Age above 18 years The presence of shortness of breath Positive PCR test for corona or lung involvement in imaging Signing informed consent and readiness to participate in the plan

Exclusion criteria
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients suffering from underlying diseases including pulmonary hypertension, kidney failure, seizures, depression, chronic hepatitis, cirrhosis and cholestatic liver diseases and pulmonary embolism (in the past 3 months) Use of anti-coagulant drugs such as warfarin, hormonal drugs and other illegal drugs (within the past 30 days) Alcohol consumption Pregnancy or breastfeeding Allergy to AAT drug Having IgA deficiency No smoking in the last 6 months

Number of arms
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mild disease at enrollment

Severity scale
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

1: Mild disease at enrollment

Total sample size
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

50

primary outcome
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

the ratio of neutrophils to lymphocytes ESR CRP IL-6 Mortality rate hospitalization time

Notes
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Nov. 2, 2022, 1:22 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1951, "treatment_name": "Alpha one antitrypsin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]