The effect of prophylaxis treatment with hydroxychloroquine on the incidence of severe forms of covid-19 virus
Design
Randomized controlled trial study; double-blind; parallel groups; on 1000 people; randomization using balanced blocks
Settings and conduct
Using balanced blocked randomization people are randomly assigned to one of the two control and intervention groups. The computerization process is done by an epidemiologist and a statistician. For the drug under study, placebo is made by a pharmaceutical company, and participants in the study are blind to receive actual medication. People who measure variables during research are also blind about how people belong to groups. (Two-way blinding)
Both intervention and control groups are followed for 10 weeks.
Participants/Inclusion and exclusion criteria
Men and women 65-18 years
wish to participate in the study
have no suspicious symptoms of covid-19 disease
Do not have positive test
Intervention groups
Intervention Group is500 people and Control Group is 500 people and they are under intervention and follow-up for 10 weeks.
Main outcome variables
- COVID-19 Mild type (fever - cough - shortness of breath and positive PCR
test)
- severe (severe dyspnea - chest pain or constant pressure - decreased level of consciousness - bruising of lips and face and positive PCR test) based on CDC definition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200421047153N1
Registration date:2020-12-19, 1399/09/29
Registration timing:retrospective
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Termeh Tarjoman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5534 6262
Email address
t.tarjoman@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-04, 1399/04/14
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Community Trial to examine the effect of hydroxychloroquine prophylaxis in preventing the sever forms of Covid-19 in asymptomatic people
Public title
Hydroxychloroquine prophylaxis in preventing the severe forms of Covid-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on
balance block randomization and by 4:1 blocks.
The randomization table was designed by the epidemiologist for a sample size of 1000 people according to the two study arms A and B (intervention and placebo). The balanced blocks were selectively four
so, A and B were repeated in these blocks. The codes listed in the table from 1
to 1000 are unique to each participant. At the time
of performance by referring to this list,a package of 10 pills (medicine or placebo) coded by a pharmaceutical expert is given to the person .
The software used is SPSS18.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals are divided in groups A or B according to the prepared sequence . The codes listed in the table are unique to each participant . After completing, the sequence will be given to the manufacturer of the drug and placebo . The company puts drugs and placebo into envelopes according to each person's code and provides the researcher with a label of person's code written on them.Therefore, participant and who will assess patients in follow-up visits will be unaware of each number belongs
to which groups(A or B).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad University of Medical Sciences l Scien ces
Street address
No16,west Goleyakh Ave.Gholhak Ave,Shariati
City
Tehran
Province
Tehran
Postal code
1946614733
Approval date
2020-04-09, 1399/01/21
Ethics committee reference number
IR.IAU.PS.REC.1399.003
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
incidence of mild type covid-19 (fever - cough - dyspnea- positive PCRtest)-CDC
Timepoint
weekly for 10 weeks
Method of measurement
phone interview -medical record review
2
Description
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
Timepoint
weekly for 10 weeks
Method of measurement
phone interview -medical record review
Secondary outcomes
1
Description
hospitalization need
Timepoint
Weekly to 10 weeks
Method of measurement
phone interview -medical record review
2
Description
mechanical ventilation need
Timepoint
Weekly to 10 weeks
Method of measurement
phone interview -medical record review
3
Description
Deaths
Timepoint
Weekly to 10 weeks
Method of measurement
phone interview -medical record review
Intervention groups
1
Description
Intervention group (500 individuals): 800 mg hydroxychlorine tablet i two separate doses daily for one week and then 200 mg tablet daily for 6 weeks
Category
Prevention
2
Description
Control group: 500 people placebo group 800 mg placebo tablet in two separate doses daily for one week and then 200 mg tablet daily for 6 weeks