| Trial registration number
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IRCT20200424047184N1 |
Full text link
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/47775
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First author
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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DR. Majid Naghipour
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Contact
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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naghipour@iautmu.ac.ir
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Registration date
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-01-16
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Recruitment status
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Prevention
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Inclusion criteria
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Healthcare workers and students of Islamic Azad University Tehran Medical Branch(IAUTMU) affiliated hospitals.
Age 18-70 years
No symptoms of COVID19 at the time of registration
No history of COVID-19 diagnosis within the past 3 months from joining the study
Desire to participate in the study and filling out the consent form
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Exclusion criteria
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Any of COVID-19 symptoms at registration: fever, chills, cough, dyspnea,runny nose, loss of smell, loss of taste, headache, sore throat, chest pain, abdominal pain, nausea, vomiting, diarrhea, malaise and musculoskeletal pain
History of COVID-19 within the past 3 months
Contraindications for hydroxychloroquine including allergy to hydroxychloroquine , G6PD, Long QT Syndrome, porphyria, retinopathy
Pregnancy
Sever kidney or liver disease
HIV, AIDS
Systemic lupus erythematosus, rheumatoid arthritis
active cancer
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Number of arms
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Islamic Azad University
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Inclusion age min
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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70
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Countries
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Health workers
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Severity scale
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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N/A
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Total sample size
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
400
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primary outcome
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Sever forms of COVID-19( sever dyspnea, chest pain, decreased level of consciousness based on CDC definition) needing admission to hospital
Sever forms of COVID-19 Diseases needing admission to ICU due to respiratory failure
Mortality
Mild types of COVID-19 with at least one of the symptoms of fever, cough, dyspnea, myalgia, loss of smell or taste, flu like symptoms with either polymerase-chain-reaction (PCR) confirmed COVID-19 or Positive CT scan suggestive of COVID-19.
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Notes
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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Phase
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2/Phase 3
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Arms
Last imported at : Jan. 17, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"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"}]
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