COVID-19. U07.1
Conditions
Interventions
Intervention 1: Intervention group: Hydroxychloroquine200mg tablet
800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days. Intervention 2: Control group: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All persons 18 years of age and older with a desire to participate in the study (resident of Tabriz), including medical staff or patient companions who have been in contact with an approved person with COVID19 over the past 4 days, and Corona test results using a nasopharyngeal swap sample (RT-PCR) and serum testing of Human SARS-Cov-2 IgG / IgM negative.
Exclusion criteria
Exclusion criteria: Positive Corona test result Allergy to Hydroxychloroquine Retinal disease History of epilepsy Known deficiency of glucose-6 phosphate dehydrogenase Chronic kidney disease known, stage 4 or 5 or under dialysis Chronic liver failure Weight <40 kg Known porphyria Current use of hydroxychloroquine History of cardiovascular disease or medication (such as amiodarone, digoxin, etc.) Recognized cancers Types of autoimmune diseases Diabetes Pregnancy or lactation Existence of fever and any respiratory illness and other infectious diseases when entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinical symptoms of COVID-19 disease (especially pulmonary involvement) among people who are asymptomatic when entering the study. Timepoint: At the beginning of the study and 7, 14 and 21 days after the start of the intervention. Method of measurement: The number of cases with clinical symptoms, especially cases of pulmonary involvement in a period of 21 days among the participants in the studied groups and as needed using CT scan results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive COVID19 test result. Timepoint: At the beginning of the study and 7, 14 and 21 days after the intervention. Method of measurement: As a number of new cases, among the studied groups , using nasopharyngeal swap sample by RT-PCR or serum antibody testing.;Hospitalization. Timepoint: Days 7, 14 and 21. Method of measurement: The results will be reported as the number of participants in each arm who need to be hospitalized with COVID19.;Discontinuation of medication or withdrawal from the study. Timepoint: Days 7, 14 and 21. Method of measurement: Using Checklist.;Death incidence. Timepoint: Days 7, 14 and 21. Method of measurement: with follow up the patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSakineh Hajebrahimi
Tabriz University of Medical Sciences
Outcome results
None listed