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Clinical Trials

1 Isotretinoin in Treatment of COVID-19 (Randomized)

Submitted by Mahmoud Elkazzaz Assessment the Activity Value of 13- cis-Retinoic Acid(Isotretinoin) in the Treatment of COVID-19 Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Ahmed M. Kabel(4), Abedelaziz Elsayed(5) ,Yousry Abo-amer(6) ,Hesham Attia(7) 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University,GOEIC,Egypt. 2. Department of Internal Medicine,Faculty of Medicine, Kafrelsheikh University, Egypt 3. Department of Cardiothoracic Surgery,Faculty of Medicine, Kafrelsheikh University, Egypt 4. Department of Clinical Pharmacy, Faculty of Medicine , Tanta University,Egypt. 5. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy,Tanta University,Egypt. 6. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital,Egypt 7. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. - Study Chair ((( Dr.Tamer Hydara))), Lecturer of Internal Medicine,Department of Internal Medicine,Faculty of Medicine, Kafrelsheikh University, Egypt - Contact: Dr.Tamer Hydara-Tel: 00201142233340 Email: tamerhydara@yahoo.com - Principal Investigator M.Sc. Mahmoud Elkazzaz, M.Sc in Biochemistry, Faculty of Science, Damietta University,GOEIC,Egypt. - Contact:Tel: 00201090302015 Email: mahmoudramadan2051@yahoo.com - The study is a randomized interventional comparative Phase III trial. 1000 adult male and female patients with positive COVID-19 diagnosis and fulfilling the below outlined inclusion criteria will be enrolled into the study. Trial population will consist of both genders. Abstract The COVID-19 pandemic caused by SARS-COV-2 has infected over 2,000,000 people causing over 150,000 deaths.Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 and for which there are currently no approved treatments. Here, the principal investigator reported according to previous studies and research findings that Isotretinoin could strongly affect both inflammation and viral entry in severe acute respiratory syndrome (SARS-CoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection via modulating and reducing cytokine storm factors (IL- 6,IL-1,IL-10 and tumor necrosis factors alpha ) which are over expressed in COVID 2019 infection and contribute to disease progression, poor outcomes and poor survival in patients infected with severe acute respiratory syndrome(SARS-CoV-2) and also, via blocking viral entry by inhibiting androgenic factors which induce Serine protease 2 expression rather than inhibition of ACE2 ,AT1 protein and Ang II-mediated intracellular calcium release pathway which is responsible for SARS-CoV-2 cell fusion and entry as opposed to ACE inhibitors (ACEIs) or angiotensin II type-I receptor blockers (ARBs) that upregulate ACE-2 receptors which might increase the risk of infection and subsequent complications Moreover, another study demonstrated that isotretinoin is a potential papain like protease (PLpro) inhibitor which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment .Retinoic acid which induce FOXP3 and CD8+,CD4+,CD25+,FOXP3+ Tregs which their absence during acute infection alters the ability of the host to limit tissue damage and also,T cells which were dramatically reduced in COVID-19 patients to exert its antiviral and anti-inflammatory effect protecting lung cells and neural cells from the inflammatory and the destructive effect of IL-6. In addition to, inducing retinoic acid inducible gene-1 (RIG-1) and endosomal toll-like receptor 3 (TLR3) as pathogen-associated molecular patterns. In adition to its anti-platelet and fibrinolytic activities protecting patients infected with covid 2019 infection from widespread blood clots.Finally, the principal investigator expects that 13cRA can inhibit COVID-19 via downregulating ACE2 , Suggesting its therapeutic potential in preventing the entry of COVID 2019 to the host cell. Keywords: COVID 2019 , Retinoic acid, Endosomal toll-like receptor 3,T Cells, IFN type1, AT1, ACE2,TMPRSS2,RIG-1.

NCT04353180 COVID19 Drug: Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Drug: Standard treatment

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