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Study aim
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The effect of injectable estradiol and testosterone in the recovery of acute respiratory, cardiac and renal failure in COVID-19 patients
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Severity of symptoms