Status:
UNKNOWN
Combination Therapy With Isotretinoin and Tamoxifen Expected to Provide Complete Protection Against Severe Acute Respiratory Syndrome Coronavirus
Lead Sponsor:
Kafrelsheikh University
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Combination Therapy with Isotretinoin and Tamoxifen expected to provide Complete Protection against Severe Acute Respiratory Syndrome Coronavirus Abstract: The COVID-19 pandemic caused by SARS-COV-2...
Detailed Description
The study is a randomized interventional comparative Phase II trial. The duration of the trial for each subject is expected to be 3 months.160 adult male and female patients with positive COVID-19 dia...
Eligibility Criteria
Inclusion
- Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes \< 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 \< 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP\>=5cmH2O))
Exclusion
- Age \< 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
- Pregnancy
- Lactation
- Depressive disorder
- Body mass index less than 18 points or higher than 25 points
- Contraindications for hormonal contraception or intrauterine device.
- Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation
- Patients receiving anti-hcv treatment
- Permanent blindness in one eye
- History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery
- The competent physician considered it inappropriate to participate in the study
- bleeding dyscrasia
- 16-1-anti-coagulation use active cervicitis
- allergy to tamoxifen
- history of venous thromboembolism
- personal history of breast or uterine malignancy
- use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04389580
Start Date
September 1 2021
End Date
December 1 2021
Last Update
July 16 2021
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