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Trial - IRCT20200421047153N1


Column Value
Trial registration number IRCT20200421047153N1
Full text link
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Farshad Hashemian

Contact
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

t.tarjoman@iautmu.ac.ir

Registration date
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2020-12-19

Recruitment status
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Prevention

Inclusion criteria
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18-65 years old No symptoms of corona and no positive corona test The desire to participate in the study No symptoms of disease at the time of admission No positive test

Exclusion criteria
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

History of allergy to hydroxychloroquine Contraindications for drug use include previous history of retinopathy or G6PD, LONG QT SYNDROME, porphyry Positive HIV patients Patients with autoimmune diseases (lupus-rheumatoid arthritis) BMI >40 Diabetic CKD Using medications with contraindication to use hydroxychloroquine

Number of arms
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Islamic Azad University

Inclusion age min
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

65

Countries
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Healthy volunteers

Severity scale
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

N/A

Total sample size
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

1000

primary outcome
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

incidence of mild type covid-19 (fever - cough - dyspnea- positive PCRtest)-CDC incidence of severe type (dyspnea - chest pain or pressure - decreased level of consciousness - bruising of the lips and face and positive PCR test) based on CDC definition

Notes
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : Dec. 20, 2020, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]