There are 3 clinical trials

Clinical Trials

1 The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.

NCT04326790 Corona Virus Disease 19 (Covid 19) Drug: Colchicine Drug: Standard treatment

MeSH:Virus Diseases

2 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

3 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial

Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.

NCT04359095 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Pill Drug: Azithromycin Other: Standard treatment

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