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Trial - IRCT20200509047364N2


Column Value
Trial registration number IRCT20200509047364N2
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Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Teamur Aghamolaei

Contact
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

research@hums.ac.ir

Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-08-17

Recruitment status
Last imported at : Dec. 21, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

All COVID-19 patients whose disease has been confirmed by the PCR test for SARS-Cov-2. Signing the written consent of the study participant.

Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

All Immunocompromised patients End stage renal disease Moderate renal insufficiency (creatinine clearance 30-50 mL/min) stage 4 sever chronic kidney disease requiring dialysis (i.e creatinine clearance <30 mL/min) History of hepatic disease History of hepatitis C infection History of alcoholism G-6-PD (glucose-6-phosphate dehydrogenase deficiency) ALT/AST >5 times the upper limit of normal. History of or evidence of QT prolongation on ECG examination History of psoriasis History of porphyria Pregnancy Use of oral contraceptive pills (OCP) Concomitant use of Dasatinib Concomitant use of Neratinib Concomitant use of Ozanimod Concomitant use of Pazopanib Concomitant use of Rilpivirine Concomitant use of Siponimod Concomitant use of Tizanidine Allergy to any study medication

Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Bandare-abbas University of Medical Sciences

Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0

Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

0: No restriction on type of patients

Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

20

primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Respiratory rate Oxygen saturation state Lung infiltration status Lactate Dehydrogenase(LDH) level's C-reactive protein(CRP) level's Lymphocyte count Platelet count

Notes
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Oct. 26, 2020, 8:37 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]