Protocol summary

Study aim
The effect of injectable estradiol and testosterone in the recovery of acute respiratory, cardiac and renal failure in COVID-19 patients
Design
Clinical trial with control group, with parallel groups, single blinded, and simple randomized, performed on 80 patients. The random number table was used for randomization.
Settings and conduct
In this study, blood serum sample is obtained from 80 COVID-19 patients with respiratory, cardiac, and kidney failure which hospitalized. Testosterone, estrogen, progesterone, and TSH are measured. Afterward, patients are randomized in two groups 40 subjects of case and control (equally in sex). Patients are blinded from the case and control groups. Control group receive common treatment and in intervention group, sex hormones injected to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: COVID-19 patients with respiratory, heart or kidney failure exclusion criteria: History of breast cancer in females, History of prostate cancer in males, History of thromboembolism in both sexes, suspected breast examination in women, High PSA in primary laboratory tests
Intervention groups
Intervention group: Patients in addition to conventional therapies receive Depo– testosterone vial 200 ng/ml per week in male subjects and Medroxy Progesterone (Depo-Provera) 150mg/ml or progesterone intramuscular injection 60 mg/d per day in female subjects. In case of positive effect on controlling the patient's symptoms and low level of sex hormones in blood sample, it can be repeated every week. Control group: Patients receive common treatment for COVID-19 based on national protocol including Hydroxychloroquine 200 mg UID twice a day, Naproxen 200 mg UID twice a day, Azithromycin 250 per day.
Main outcome variables
Severity of symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150716023235N15
Registration date: 2020-05-29, 1399/03/09
Registration timing: registered_while_recruiting

Last update: 2020-05-29, 1399/03/09
Update count: 0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of sex hormones in the control of coronavirus inflammation
Public title
sex hormones in coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 patients with respiratory, heart or kidney failure
Exclusion criteria:
History of breast cancer in females History of prostate cancer in males History of thromboembolism in both sexes Suspected breast examination in women High PSA in primary laboratory tests
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly divided into two groups using a random number table. Individuals who receive the odd number enter the intervention group, and people with even numbers are placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, patients are not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreishi building Ethics Committee of Mashahd University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MUMS.REC.1399.192

Health conditions studied

1

Description of health condition studied
Severity of COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Severity of disease
Timepoint
before intervention and every week until one month
Method of measurement
observation

2

Description
IL-6
Timepoint
before intervention and every week until one month
Method of measurement
Elisa

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: COVID-19 Patients with respiratory, heart, or kidney failure over 50 years of age in addition to conventional therapies received Depo– testosterone vial 200 ng/ml per week in male subjects and Medroxy Progesterone (Depo-Provera) 150mg/ml or progesterone intramuscular injection 60 mg/d per day in female subjects. In case of positive effect on controlling the patient's symptoms and low level in the prepared sample, it can be repeated every week.
Category
Treatment - Drugs

2

Description
Control group: COVID-19 patients with respiratory, heart or kidney failure above 50 years old which received common treatment for COVID-19 based on national protocol including Hydroxychloroquine 200 mg UID twice a day, Naproxen 200 mg UID twice a day, Azithromycin 250 per day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Farahzad Jabbari-Azad
Street address
Ahmad Abad Ave., Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
+98 51 3801 2298
Email
Jabbarif@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
Ghoreishi,Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Phone
+98 51 3841 2081
Email
Ramresearch@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
Farahzad Jabbari-Azad
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
+98 51 3801 2298
Email
jabbarif@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari-Azad
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
009838012298
Email
jabbarif@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari-Azad
Position
Professor,
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghaem Hospital , Ahmadabad Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
+98 51 3801 2298
Email
تشذذشقهب@ئعئس.شز.هق

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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