Comparison of the effect of hydroxychloroquine with placebo on prevention of virus Covid-19 in Arash hospital treatment staffs
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
Arash hospital treatment staffs will be invited to participate in the study. After being assessed for inclusion and exclusion criteria and obtaining their consent, Participants Arash Hospital treatment staff will be invited to participate in the study. They will be enrolled in the study based on inclusion and exclusion criteria and after obtaining informed consent, they will be randomized into two groups, A and B.
One group of participants will be given 400 mg hydroxychloroquine twice weekly for 3 months and the other group will be given placebo. Then, in the event of clinical signs of suspected viral infection, Covid-19 tests will be carried out based on the national protocols.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Staffs who are in contact with patients, including nurse,physician, midwife and caregiver who have at least 3 shift a week in the hospital and consent to participate in the study.
Exclusion criteria: History of coronavirus infection or clinical symptoms such as fever, nausea, dispenea and myalgia in the past two months, history of underlying diseases, hypersensitivity to hydroxychloroquine, G6PD enzyme deficiency.
Participants will be randomly assigned to either A or B groups and will be assigned to one hydroxychloroquine group and one placebo group.
Main outcome variables
Covid-19 virus infection
Reason for update
IRCT registration information
IRCT registration number:IRCT20120826010664N6
Registration date:2020-04-05, 1399/01/17
Last update:2020-04-05, 1399/01/17
Name of organization / entity
Tehran University of Medical Sciences
Iran (Islamic Republic of)
+98 21 7788 3288
Expected recruitment start date
Expected recruitment end date
Actual recruitment start date
Actual recruitment end date
Trial completion date
Effect of hydroxychloroquine on prevention of covid-19 virus infection among treatment staff in Arash hospital-A double-blind clinical trial
Effect of hydroxychloroquine on prevention of covid-19 virus
Treatment staff who are in contact with patients
who have at least 3 shift a week in the hospital
consent to participate in the study.
History of covid-19 virus infection
clinical symptoms such as fever, nausea, dispenea and myalgia in the past two months
history of underlying diseases
hypersensitivity to hydroxychloroquine
G6PD enzyme deficiency
From 18 years old to 60 years old
Groups that have been masked
Target sample size:
Randomization (investigator's opinion)
The randomized block allocation method was developed using Stata version 15 software by an epidemiologist. The block size was six. Allocation to treatment groups was conducted by an independent researcher (The epidemiologist). To conceal the process of random assignment, it is written on paper labels (random 10-digit codes) with no sequences and no specific framework that identifies the relevant treatment number and only the methodologist will be aware of the code. The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according randomization list. When the physician declares a patient eligible, the methodologist will give him or her drug package. The person evaluating the outcomes is a third party who is unaware of the random allocation process and the type of treatment performed. The data will be analyzed by a statistician who is separate from the study process and unaware of all the processes performed.
Blinding (investigator's opinion)
The drug and placebo, which have similar size, color, taste, and odor, are provided in completely similar containers by random assignment to both groups, so no patients will be informed of the specific treatment. The researcher is also unaware of the implications of the random allocation process and the type of treatment performed. The data will be analyzed by a statistical expert who is separate from the study process and unaware of all the processes performed.
Other design features
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical, 400 mg daily and once a week for one to three months. (Based on the duration of corona virus epidemic).
Control group: placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy)is given.The dosage is two tablet daily , once a week for one to three months (based on duration of Corona virus epidemic in Tehran).