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Trial - IRCT20190215042716N2


Column Value
Trial registration number IRCT20190215042716N2
Full text link
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

http://en.irct.ir/trial/63257

First author
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Navid Shafigh

Contact
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

n.shafigh@sbmu.ac.ir

Registration date
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-05-30

Recruitment status
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

multi-center

Study aim
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patient with Covid-19 and PCR positive Age over 18 years Hospitalized

Exclusion criteria
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

No treatment of the patient or guardian to continue cooperation

Number of arms
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4

Funding
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahid Beheshti University of Medical Sciences

Inclusion age min
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

300

primary outcome
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

blood oxygen levels

Notes
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : May 31, 2022, 1:02 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "Rectal method: 25 ml anal (rectal), used four times a day.", "treatment_id": 947, "treatment_name": "Oxygen therapy", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Sublingual method: oral solution (H2O8) should be swallowed by the patient in the mouth for 2 to 4 minutes and then gently swallowed.", "treatment_id": 947, "treatment_name": "Oxygen therapy", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Inhalation method of using solution (H2O8) in vials containing 5 ml", "treatment_id": 947, "treatment_name": "Oxygen therapy", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]