Determining the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in patients with cancer.
Design
This is a two-arm, parallel-group, triple-blind, randomised controlled trial.
Settings and conduct
During two months of treatment, the two groups were treated with hydroxychloroquine every other day with a 200 mg tablet or placebo, during this time they will be monitored for COVID-19 symptoms. If signs or symptoms occur (fever, cough, shortness of breath), they will be examined with a high resolution computerize tomography (CT) scan of the lungs and a nucleic acid amplification test (NAT) for the SARS-CoV-2 virus. Both the patient and the treating physician are blind to medication / placebo. The data analyser is also blinded regarding the allocated groups. This study is performed in five academic hospitals affiliated to Mashhad University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients older than 15 years.
Patients with curable Acute Lymphoblastic Leukemia.
Patients with curable Acute Myeloblastic Leukemia.
Patients with curable high-grade non-Hodgkin Lymphoma.
Adult patients (over 15 years) with curable Breast cancer.
Adult patients (over 15 years) with curable Colon cancer.
Exclusion criteria:
Known sensitivity to Hydroxychloroquine.
Weight bellow 35 kilograms.
History of retinopathy.
History of any cardiac disease.
Acute respiratory tract infection in the last 2 month.
Having COVID-19 in the first two weeks of entering the trial.
Having Diabetes Mellitus.
Having immuno-suppressive disease other than cancer.
Having chronic pulmonary disease.
Taking immuno-suppressant drug other than chemotherapeutic agents for current cancer.
Intervention groups
Patients are randomly assigned to two groups, one being given hydroxychloroquine and the other is given placebo.
Main outcome variables
COVID-19 incidence rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200405046958N1
Registration date:2020-04-14, 1399/01/26
Registration timing:registered_while_recruiting
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Mohammad Moeini Nodeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2742
Email address
moeininm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-06-14, 1399/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment
Public title
Prevention of Novel Coronavirus Disease by Hydroxychloroquine in cancer patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with curable Acute Lymphoblastic Leukemia
Patients with curable Acute Myeloblastic Leukemia
Patients with curable high-grade non-Hodgkin Lymphoma
Patients with curable Breast cancer
Patients with curable Colon cancer
Age higher than 15 years
Exclusion criteria:
Known sensitivity to Hydroxychloroquine
Weight lower than 35 kilograms
History of retinopathy
History of any cardiac disease
Acute respiratory tract infection in the last 2 month
Having novel Coronavirus in the first two weeks of entering the trial
Diabetes Mellitus
Immuno-suppressive disease other than cancer
Chronic pulmonary disease
Taking immuno-suppressive drugs other than cancer chemotherapy
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using randomly permuted blocks. By using online website (www.randomization.com) the randomization sequence will be produced by quadruple blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient and the physician do not know whether the patient is in the intervention or the control group. The data analyser will also be blinded regarding the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
MUMS (Mashhad University of Medical Sciences) medical ethics committee
Street address
Central Building of MUMS, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.MUMS.REC.1399.078
Health conditions studied
1
Description of health condition studied
COVID-19 disease
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
2
Description of health condition studied
Acute myeloid leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
3
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
4
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
5
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
6
Description of health condition studied
Diffuse large B cell lymphoma
ICD-10 code
C83.3
ICD-10 code description
Diffuse large B-cell lymphoma
Primary outcomes
1
Description
COVID-19 incidence rate in cancer patients under treatment.
Timepoint
Patients are examined and investigated if they become symptomatic during the 2 months of study.
Method of measurement
First, a history and physical examination are performed for the symptoms of COVID-19, and if the test is positive, a computerized tomography scan of the lungs and a nucleic acid amplification test for the SARS-CoV-2 virus.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention arm: Patients in this group receive 200 mg of hydroxychloroquine tablets (manufactured by Amin Pharmaceutical Company, Isfahan) every other day for 2 months. At the same time, specific cancer treatments are given.
Category
Prevention
2
Description
Control arm: Patients receive the placebo, which is similar to Amin's hydroxychloroquine tablets, one every other day. Cancer treatment of these patients is done according to the standard during this period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mohammad Moeini Nodeh
Street address
Ghaem hospital, Ahmadabad Ave, Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175856499
Phone
+98 51 3801 2742
Email
moeininm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
tafaghodim@mums.ac.ir
Web page address
https://mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moeini Nodeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Internal medicine department, Ghaem hospital, Ahmadabad Ave, Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175856499
Phone
+98 51 3801 2742
Email
moeininm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moeini Nodeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Internal medicine department, Ghaem Hospital, Ahmadabad Ave, Shariati Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175856499
Phone
+98 51 3801 2742
Email
moeininm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Moeini Nodeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology Oncology
Street address
Internal Medicine Department, Ghaem Hospital, Ahmadabad Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175856499
Phone
+98 51 3801 2742
Fax
Email
moeininm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available