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Trial - IRCT20200513047426N1


Column Value
Trial registration number IRCT20200513047426N1
Full text link
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)

Vice chancellery for research and technology

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

Drrezaee.ramin@yahoo.com

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

2020-06-27

Recruitment status
Last imported at : Oct. 26, 2020, 8:37 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)

Prevention

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

Close contact with a person with COVID-19 who has been diagnosed positive with a definitive test. Close contact: contact, hand shake and talking at least once in the last 2 days for less than 2 meters with COVID-19 patient who have been diagnosed positive with a definitive test. Family, friends, relatives who have been in the same place for a period of 4 hours or more in the last 2 days with a COVID-19 patient who have been diagnosed with a definitive test . Medical staff, including physicians, nurses, midwives, and service personnel which have been in contact with COVID-19 patient who has been diagnosed with a definitive test in the past three days.

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

Lack of satisfaction from entered persons The presence of diseases or conditions in which the use of hydroxychloroquine is as a contraindication, such as patients with heart failure who take QT prolonging drugs are as contraindications. Existence of distorting factors during the implementation of clinical trial.+ During the study, people should be in home quarantine . + Do not Excessive use of vitamins and medications.+ has Meals like family’s.+has Regular sleep cycle Complications of hydroxychloroquine based on the Iranian rheumatology association include the following:1- Nausea, decreased appetite and diarrhea 2- Skin allergies 3- Skin discoloration 4- Ocular sensitivity 5- Headache 6- Rush

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)

Boushehr 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)

Close contacts to covid patients

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

N/A

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

500

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

Percentage of people who have not been diagnosed with Covid19 after co-administration of hydroxychloroquine.

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": 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"}]