[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100393375":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Bangladesh Medical Research Council (BMRC)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Favipiravir + Standard Treatment","EXPERIMENTAL","Favipiravir 200 mg (Favipira) tablet will be given orally. Day 1: Tablet Favipiravir 1600 mg twice daily Days 2-Days 10: Tablet Favipiravir 600 mg twice daily.",[13],"Drug: Favipiravir",{"label":15,"type":16,"description":17,"interventionNames":18},"Only Standard Treatment","PLACEBO_COMPARATOR","Standard treatment included oxygen inhalation, oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \\& the medication any patient is on due to any concomitant diseases.",[19],"Drug: Only Standard Treatment",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Favipiravir",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Ahmedul Kabir, MBBS, FCPS, FACP, FRCP","CONTACT","+88 01720910541","ahmedul_986@yahoo.com",[35],{"facility":36,"status":37,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Mahanagar General Hospital, Dhaka (Site-1), Mugda Medical College Hospital, Dhaka (Site-2), Kurmitola General Hospital, Dhaka (Site-3), Dhaka Medical College Hospital, Dhaka (Site-4)","RECRUITING","Dhaka","Bangladesh","BD",{"type":42,"coordinates":43},"Point",[44,45],90.40744,23.7104,{"lat":45,"lon":44},[48,50],{"name":49,"role":31,"phone":32,"phoneExt":25,"email":33},"Ahmedul Kabir, MBBS, FCPS FACP, FRCP",{"name":51,"role":31,"phone":52,"phoneExt":25,"email":53},"Md. Billal Alam, MBBS, FCPS MD, MACP, FACP","+88 01716210121","profbillal66@gmail.com",{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100393375","phase-2-study-on-safety-and-efficacy-of-favipiravir-favipira-for-covid-19-patient-in-selected-hospitals-of-bangladesh-100393375",false,"NCT04402203","Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh","Inclusion Criteria:\n\n1. Age: Male or female patients 18 -65 years old\n2. Respiratory samples tested positive for the novel coronavirus.\n3. Initial symptoms will within 7 days\n4. Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to enrollment)\n\nExclusion Criteria:\n\n1. Severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (OI) \\\u003C 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and\u002For combined failure of other organs that required ICU monitoring and treatment).\n2. Chronic liver and kidney disease and reaching end stage. (Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over 5 times of normal upper range will excluded).\n\n   (Normal upper limit of Serum AST = 40 units \u002FL, ALT = 56 units \u002FL)\n3. Serum uric acid \\>7.0 mg\u002FdL in Male and Serum uric acid \\>6.0 mg\u002FdL in Female will excluded\n4. ICU patient\n5. Previous history of allergic reactions to Favipiravir.\n6. Pregnant or lactating women\n7. Women of a childbearing age with a positive pregnancy test.\n8. Miscarriage, or within 2 weeks after delivery\n9. Hypertensive patients, who are taking Calcium Channel Blockers","ALL","18 Years","65 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE2","PHASE3","A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan, China, at the end of 2019. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnea, and pneumonia. As of 25 February 2020, at least 77 785 cases and 2666 deaths had been identified across China and in other countries; in particular, 977 and 861 cases were identified in South Korea and Japan, respectively. The outbreak has already caused global alarm. On 30 January 2020, the World Health Organization (WHO) declared that the outbreak of SARS-CoV-2 constituted a Public Health Emergency of International Concern (PHEIC), and issued advice in the form of temporary recommendations under the International Health Regulations (IHR).It has been revealed that SARS-CoV-2 has a genome sequence that is 75%-80% identical to that of SARS-CoV, and has more similarities to several bat coronaviruses. SARS-CoV-2 is the seventh reported human-infecting member of the family Coronaviridae, which also includes SARS-CoV and the Middle East respiratory syndrome (MERS)-CoV. It has been identified as the causative agent of COVID-19. Both the clinical and the epidemiological features of COVID-19 patients demonstrate that SARS-CoV-2 infection can lead to intensive care unit (ICU) admission and high mortality. About 16%-21% of people with the virus in China have become severely ill, with a 2%-3% mortality rate. However, there is no specific treatment against the new virus.\n\nTherefore, it is urgently necessary to identify effective antiviral agents to combat the disease and explore the clinical effect of antiviral drugs. One efficient approach to discover effective drugs is to test whether the existing antiviral drugs are effective in treating other related viral infections. Several drugs, such as ribavirin, interferon (IFN), Favipiravir (FPV), and Lopinavir (LPV)\u002Fritonavir (RTV), have been used in patients with SARS or MERS, although the efficacy of some drugs remains controversial. It has recently been demonstrated that, as a prodrug, Favipiravir (half maximal effective concentration (EC50) = 61.88 μmol·L-1, half-maximal cytotoxic concentration (CC50) \\> 400 μmol·L-1, selectivity index (SI) \\> 6.46) effectively inhibits the SARS-CoV-2 infection in Vero E6 cells (ATCC-1586). Furthermore, other reports show that FPV is effective in protecting mice against Ebola virus challenge, although its EC50 value in Vero E6 cells was as high as 67 μmol·L-1. Therefore, clinical studies are urgently needed to evaluate the efficacy and safety of this antiviral nucleoside for COVID-19 treatment. After enrollment of the patients (day 1) depending on inclusion and exclusion criteria and laboratory findings confirming the presence of the COVID-19 virus, 25 patients will receive Favipiravir plus standard treatment and the second group of 25 patients will receive standard treatment only. The comparison of the findings of the follow up studies on days 4, 7, and 10 in terms of clinical manifestations, chest X-ray and laboratory findings, such as Real Time Polymerase Chain Reaction (RT-PCR) results for viral presence will determine whether Favipiravir has safety and efficacy against COVID-19 infections.\n\nAll ethical issues related to this trial including right of the participants to withdraw from the study should be maintained according to of guidelines of International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).",[74,75],"COVID-19","Favipiravir (Favipira)","UNKNOWN","2020-05-22",{"date":79,"type":80},"2020-05-26","ACTUAL",{"date":82,"type":67},"2020-05",{"date":84,"type":67},"2020-07",{"name":5,"class":6},1]