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Trial - IRCT20200404046932N1


Column Value
Trial registration number IRCT20200404046932N1
Full text link
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

http://en.irct.ir/trial/58879

First author
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Sayyed Ali Alavi

Contact
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

sayyedalialavi@gmail.com

Registration date
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-10-14

Recruitment status
Last imported at : Dec. 22, 2021, 5:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Age 18 years and older Signing informed consent Possessing two distinct respiratory signs of COVID-19 O2Sat below 94% or positive signs on CT scan or positive PCR result for COVID-19

Exclusion criteria
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

History of moderate or severe respiratory asthma Participating in another clinical trial for COVID-19

Number of arms
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4

Funding
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Hakiman e Shargh Research Co.

Inclusion age min
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

primary outcome
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

O2sat difference one hour post intervention

Notes
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 2

Arms
Last imported at : Oct. 15, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "single dose 5mL", "treatment_id": 2341, "treatment_name": "Fluvar", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "two times a day, 5mL every dose", "treatment_id": 2341, "treatment_name": "Fluvar", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]