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Trial - IRCT20210709051824N1


Column Value
Trial registration number IRCT20210709051824N1
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Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Seyed Jalil Hoseini

Contact
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

mhrhrc@yahoo.com

Registration date
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-12-08

Recruitment status
Last imported at : Feb. 20, 2022, 5:42 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Patients with acute or chronic renal failure, with a definitive diagnosis of Covid 19, over the age of 18 years, and lung involvement above 20% or hypoxia (oxygen saturation less than or equal to 93%) Definitive diagnosis of Covid 19 Over the age of 18 years Pulmonary involvement caused by Covid 19

Exclusion criteria
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Previous history of COVID-19 infection and heart disease and receiving Remdesivir History of lung disease History of liver disease (such as hepatitis, cirrhosis) History of underlying diseases other than renal impairment that contribute to poor prognosis and increased mortality following coronary heart disease (eg, heart failure, active cancer, advanced diabetes with severe macrovascular and microvascular complications, previous stroke) Immunosuppressive use except in the field of kidney transplantation Prohibition of Ramdesivir (except low GFR)

Number of arms
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Men's Health and Reproductive Health Research Center(MHRHRC)

Inclusion age min
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

primary outcome
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Red blood cell count Platelet count White blood cell count Medium platelet volume Erythrocyte Sedimentation Rate CRP AST ALT International Normalized Ratio(INR) Bilirubin Alkaline phosphatase Cratinin O2 Saturation lymphocyte count Neutrophil count Duration of hospitalization Result of hospitalization(Death or discharge)

Notes
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Dec. 9, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]