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Trial - IRCT20210510051248N1


Column Value
Trial registration number IRCT20210510051248N1
Full text link
Last imported at : Jan. 22, 2022, 2 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Mehraban Sadeghi

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

vcrt@skums.ac.ir

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

2022-01-22

Recruitment status
Last imported at : March 21, 2022, 10:14 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

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

RCT

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

Randomized

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

Parallel

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

Blind label

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

single-center

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

Treatment

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

Patients with confirmed molecular test (PCR positive) Blood oxygen saturation level SpO2 <93% in room air Patients with moderate pulmonary involvement in radiological studies No need for antibiotics in terms of indicator bacterial infection (PCT negative)

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

Patient dissatisfaction with participation in the study Need for antibiotics according to the indication of bacterial infection (PCT positive)

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

2

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

Shahre-kord University of Medical Sciences

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

18

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

90

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

Iran

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

Severe disease at enrollment

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

6: Severe disease at enrollment

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

90

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

Erythrocyte Sedimentation rate C-reactive protein ferritin

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

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

Phase 2/Phase 3

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

[{"arm_notes": "", "treatment_id": 2128, "treatment_name": "Ceftriaxone+levofloxacin+remdesivir", "treatment_type": "Antibiotics+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]