[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419780":3},{"organization":4,"armGroups":7,"interventions":103,"overallOfficials":173,"centralContacts":177,"locations":183,"responsibleParty":271,"collaborators":273,"id":281,"slug":282,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":283,"sex":289,"minAge":290,"maxAge":18,"enrollmentInfo":291,"targetDuration":18,"studyType":294,"phases":295,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":206,"whyStopped":18,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},{"fullName":5,"class":6},"University of Liverpool","OTHER",[8,14,19,25,30,35,41,46,50,53,58,60,64,70,72,76,80,85,90,95,99],{"label":9,"type":10,"description":11,"interventionNames":12},"CST-2 EIDD-2801 Phase Ib","EXPERIMENTAL","EIDD-2801 (also known as MK-4482, molnupiravir). Phase Ib: EIDD-2801 will be administered orally, twice daily (BID) for 10 doses (5 or 6 days). The starting dose will be established based on safety and pharmacokinetics from the EIDD-2801-1001-US\u002FUK study, and dose escalations may occur as described in this CST.",[13],"Drug: CST-2: EIDD-2801",{"label":15,"type":16,"description":17,"interventionNames":18},"CST-2 Control","NO_INTERVENTION","Phase 1b only (standard of care)",null,{"label":20,"type":21,"description":22,"interventionNames":23},"CST-2 Placebo","PLACEBO_COMPARATOR","Phase II placebo blinded controlled",[24],"Drug: CST-2: Placebo",{"label":26,"type":10,"description":27,"interventionNames":28},"CST-3A Nitazoxanide","Phase Ia Nitazoxanide will be administered orally, initially twice daily (BID) for 14 doses (7 days). The starting dose will be 1500mg BID based on existing dose information, but dose adaptations may occur",[29],"Drug: Nitazoxanide",{"label":31,"type":10,"description":32,"interventionNames":33},"CST-5 VIR-7832 Phase I","Phase I: Single doses of VIR-7832 will be administered by intravenous (IV) infusion. The starting dose will be 50 mg, and dose escalations of 150 and 500 mg are anticipated.",[34],"Drug: VIR-7832",{"label":36,"type":37,"description":38,"interventionNames":39},"CST-5 VIR-7831 Phase II","ACTIVE_COMPARATOR","Phase II: 500 mg dose of VIR-7831 will be given by IV infusion.",[40],"Drug: VIR-7831",{"label":42,"type":21,"description":43,"interventionNames":44},"CST-5 Placebo Phase I","Phase I: placebo blinded controlled",[45],"Drug: CST-5: Placebo",{"label":47,"type":10,"description":48,"interventionNames":49},"CST3B Nitazoxanide","Phase II experimental arm.",[29],{"label":51,"type":16,"description":52,"interventionNames":18},"CST3B Control","Standard of care",{"label":54,"type":10,"description":55,"interventionNames":56},"CST6 IV Favipiravir","IV Favipiravir twice daily for 7 days. Starting dose 600 mg twice daily. Dose escalation to 1200 mg twice daily, 1800 twice daily, 2400 twice daily.",[57],"Drug: Favipiravir",{"label":59,"type":16,"description":52,"interventionNames":18},"CST6 Control",{"label":61,"type":10,"description":62,"interventionNames":63},"CST-2 EIDD-2801 Phase II","EIDD-2801 (also known as MK-4482, molnupiravir).\n\nPhase II: As per Phase Ib, with the dose determined by the recommended phase II dose.",[13],{"label":65,"type":10,"description":66,"interventionNames":67},"CST-8 Phase I Molnupiravir + Paxlovid®","Molnupiravir 800mg Twice a day (BD) in combination with Paxlovid® (300mg nirmatrelvir + ritonavir 100mg) twice a day (BD) for 5 days as starting dose, with a de-escalation protocol reducing in increments of molnupiravir to 600mg BD, then 400mg BD if required. The dose of Paxlovid® will be fixed for all cohorts.",[68,69],"Drug: Molnupiravir","Drug: Paxlovid",{"label":71,"type":16,"description":52,"interventionNames":18},"CST-8 Phase I Molnupiravir + Paxlovid® Control",{"label":73,"type":37,"description":74,"interventionNames":75},"CST-5 VIR-7832","Phase II: 500 mg dose of VIR-7832 will be given by IV infusion.",[34],{"label":77,"type":21,"description":78,"interventionNames":79},"CST-5 Placebo Phase II","Phase II: placebo blinded controlled",[45],{"label":81,"type":10,"description":82,"interventionNames":83},"CST-9a Monotherapy","Phase II: ALG-097558 600 mg twice a day orally for 5 days",[84],"Drug: ALG-097558",{"label":86,"type":10,"description":87,"interventionNames":88},"CST-9a Combination","Phase II: ALG-097558 600 mg twice a day orally for 5 days in combination with IV remdesivir for 3 days (200 mg day 1, 100 mg day 2 and 3)",[84,89],"Drug: ALG-097558 and Remdesivir",{"label":91,"type":37,"description":92,"interventionNames":93},"CST-9a Control","Phase II : standard of care",[94],"Drug: NHS standard of care as per COVID-19 treatment guidelines",{"label":96,"type":10,"description":97,"interventionNames":98},"CST-9b: ALG-097558","twice daily dose for 5 days",[84],{"label":100,"type":21,"description":18,"interventionNames":101},"CST-9b: placebo for ALG097558",[102],"Drug: Placebo",[104,112,118,122,126,132,137,141,146,152,156,162,167,170],{"type":105,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"DRUG","CST-2: EIDD-2801","CST-2 Phase Ib: EIDD-2801 will be administered orally, twice daily (BID) for 10 doses (5 or 6 days). The starting dose will be established based on safety and pharmacokinetics from the EIDD-2801-1001-US\u002FUK study, and dose escalations may occur as described in this CST.\n\nPhase II: As per Phase Ib, with the dose determined by the recommended phase II dose.",[61,9],[110,111],"MK-4482","Molnupiravir",{"type":105,"name":113,"description":114,"armGroupLabels":115,"otherNames":116},"CST-2: Placebo","CST-2 Phase II: Placebo will be administered orally, twice daily (BID) for 10 doses (5 or 6 days).",[20],[117],"Placebo",{"type":105,"name":119,"description":120,"armGroupLabels":121,"otherNames":18},"Nitazoxanide","CST3A \\& CST3B Phase I: Nitazoxanide will be administered orally, initially twice daily (BID) for 14 doses (7 days). The starting dose will be 1500mg BID based on existing dose information, but dose adaptations may occur.\n\nPhase II: As per Phase Ib, with the dose determined by the recommended phase II dose.",[26,47],{"type":105,"name":123,"description":124,"armGroupLabels":125,"otherNames":18},"VIR-7832","CST-5: Phase I, Single doses of VIR-7832 will be administered by intravenous (IV) infusion over 1 hour. The starting dose will be 50 mg, and dose escalations of 150 and 500 mg are anticipated, with escalation guided by emerging safety data and decision by the SRC.\n\nPhase II: As per Phase I, with the dose determined by the recommended phase II dose.",[73,31],{"type":105,"name":127,"description":128,"armGroupLabels":129,"otherNames":130},"VIR-7831","CST-5 Phase II: A 500 mg dose of VIR-7831 will also be given by IV infusion over 1 hour.",[36],[131],"Sotrovimab",{"type":105,"name":133,"description":134,"armGroupLabels":135,"otherNames":136},"CST-5: Placebo","CST-5 Phase 1, Phase II: Placebo given by intravenous infusion over 1 hour",[42,77],[117],{"type":105,"name":138,"description":139,"armGroupLabels":140,"otherNames":18},"Favipiravir","CST-6: Multiple doses of IV Favipiravir will be administered by intravenous (IV) infusion over 1 hour. Dosing regimen will be every 12 hours for 7 days duration. The starting dose will be 600mg (BID), and dose escalations to 1200mg (BID), 1800mg (BID) and 2400mg (BID) are anticipated as well as a de-escalation dose of 300mg (BID) if necessary, with de-escalation and escalation guided by emerging safety data and decision by the Safety Review Committee (SRC).",[54],{"type":105,"name":111,"description":142,"armGroupLabels":143,"otherNames":144},"Molnupiravir 800mg Twice a day (BD) for 5 days as starting dose, with a de-escalation protocol reducing in increments of molnupiravir to 600mg BD, then 400mg BD if required.",[65],[145],"Lagevrio",{"type":105,"name":147,"description":148,"armGroupLabels":149,"otherNames":150},"Paxlovid","Paxlovid® (300mg nirmatrelvir + ritonavir 100mg) twice a day (BD) for 5 days. The dose of Paxlovid® will be fixed for all cohorts.",[65],[151],"nirmatrelvir and ritonavir",{"type":105,"name":153,"description":154,"armGroupLabels":155,"otherNames":18},"ALG-097558","ALG-097558 600 mg Twice a day (BD) for 5 days",[86,81],{"type":105,"name":157,"description":158,"armGroupLabels":159,"otherNames":160},"ALG-097558 and Remdesivir","ALG-097558 600 mg Twice a day (BD) for 5 days Remdesivir will be administered once daily by intravenous infusion over 30 to 120 minutes. 200 mg will be given on day 1 and 100 mg on day 2 and day 3.",[86],[161],"ALG-097558 and veklury",{"type":105,"name":163,"description":163,"armGroupLabels":164,"otherNames":165},"NHS standard of care as per COVID-19 treatment guidelines",[91],[166],"any of the following: nirmatrelvir plus ritonavir (Paxlovid) sotrovimab (Xevudy) molnupiravir (Lagevrio)",{"type":105,"name":153,"description":168,"armGroupLabels":169,"otherNames":18},"twice daily (Q12H) oral dose of ALG-097558",[96],{"type":105,"name":117,"description":171,"armGroupLabels":172,"otherNames":18},"twice daily (Q12H) oral dose",[100],[174],{"name":175,"affiliation":5,"role":176},"Saye Khoo","PRINCIPAL_INVESTIGATOR",[178],{"name":179,"role":180,"phone":181,"phoneExt":18,"email":182},"Helen E Reynolds","CONTACT","+44 (0)1517945553","livagile@liv.ac.uk",[184,196,204,228,237,245,256],{"facility":185,"status":186,"city":187,"state":18,"zip":18,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":195,"contacts":18},"Desmond Tutu Health Foundation","COMPLETED","Cape Town","South Africa","ZA",{"type":191,"coordinates":192},"Point",[193,194],18.42322,-33.92584,{"lat":194,"lon":193},{"facility":197,"status":186,"city":198,"state":18,"zip":18,"country":188,"countryCode":189,"cosmosGeoPoint":199,"geoPoint":203,"contacts":18},"Ezintsha","Johannesburg",{"type":191,"coordinates":200},[201,202],28.04363,-26.20227,{"lat":202,"lon":201},{"facility":205,"status":206,"city":207,"state":18,"zip":208,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Liverpool University Hospitals NHS Foundation Trust","RECRUITING","Liverpool","L7 8XP","United Kingdom","UK",{"type":191,"coordinates":212},[213,214],-2.97794,53.41058,{"lat":214,"lon":213},[217,220,222,224,226],{"name":18,"role":180,"phone":218,"phoneExt":18,"email":219},"+44 (0)151 706 4863","crf.contact@liverpoolft.nhs.uk",{"name":18,"role":180,"phone":221,"phoneExt":18,"email":18},"+44(0)7342065915",{"name":223,"role":176,"phone":18,"phoneExt":18,"email":18},"Richard FitzGerald",{"name":225,"role":176,"phone":18,"phoneExt":18,"email":18},"Lauren Walker",{"name":227,"role":176,"phone":18,"phoneExt":18,"email":18},"Thomas Fletcher",{"facility":229,"status":230,"city":231,"state":18,"zip":18,"country":209,"countryCode":210,"cosmosGeoPoint":232,"geoPoint":236,"contacts":18},"Kings College Hospital NHS Foundation Trust","ACTIVE_NOT_RECRUITING","London",{"type":191,"coordinates":233},[234,235],-0.12574,51.50853,{"lat":235,"lon":234},{"facility":238,"status":206,"city":231,"state":18,"zip":18,"country":209,"countryCode":210,"cosmosGeoPoint":239,"geoPoint":241,"contacts":242},"Royal Free Hospital",{"type":191,"coordinates":240},[234,235],{"lat":235,"lon":234},[243],{"name":244,"role":176,"phone":18,"phoneExt":18,"email":18},"Sanjay Bhagani",{"facility":246,"status":206,"city":247,"state":18,"zip":18,"country":209,"countryCode":210,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Manchester University NHS Foundation Trust","Manchester",{"type":191,"coordinates":249},[250,251],-2.23743,53.48095,{"lat":251,"lon":250},[254],{"name":255,"role":176,"phone":18,"phoneExt":18,"email":18},"Shazaad Ahmad",{"facility":257,"status":206,"city":258,"state":18,"zip":259,"country":209,"countryCode":210,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"University Hospital Southampton NHS Foundation Trust","Southampton","SO16 6YD",{"type":191,"coordinates":261},[262,263],-1.40428,50.90395,{"lat":263,"lon":262},[266,269],{"name":18,"role":180,"phone":267,"phoneExt":18,"email":268},"+44 (0)7469565895","UHS.SouthamptonCRF@nhs.net",{"name":270,"role":176,"phone":18,"phoneExt":18,"email":18},"Chris Edwards",{"type":272,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[274,276,279],{"name":275,"class":6},"Liverpool School of Tropical Medicine",{"name":277,"class":278},"Royal Liverpool University Hospital","OTHER_GOV",{"name":280,"class":6},"University of Cambridge","100419780","phase-1-agile-early-phase-platform-trial-for-covid-19-100419780",false,"NCT04746183","AGILE (Early Phase Platform Trial for COVID-19)","AGILE: Seamless Phase I\u002FIIa Platform for the Rapid Evaluation of Candidates for COVID-19 Treatment","AGILE","Master Protocol Inclusion Criteria:\n\n1. Adults (≥18 years) with laboratory-confirmed\\* SARS-CoV-2 infection (PCR)\n2. Ability to provide informed consent signed by study patient or legally acceptable representative\n3. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in the protocol) from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment\n\n   * If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible.\n\nStandard additional criteria that may be applied per CST protocol:\n\nGroup A (severe disease) 4a. Patients with clinical status of Grades 4 (hospitalised, oxygen by mask or nasal prongs), 5 (hospitalised, on non-invasive ventilation, or high flow oxygen), 6 (hospitalised, intubation and mechanical ventilation) or 7 (ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)), as defined by the WHO clinical severity score, 9-point ordinal scale.\n\nGroup B (mild-moderate disease) 4b. Ambulant or hospitalised patients with the following characteristics peripheral capillary oxygen saturation (SpO2) \\>94% RA N.B. The CST protocol inclusion criteria will take precedence over the master protocol inclusion criteria.\n\nCST-2 Inclusion Criteria:\n\nFor the purpose of the EIDD-2801 candidate-specific trial the following inclusion criteria have been amended from the Master protocol to:\n\n1\\. Male or female ≥ 60 years old or ≥50 years old with at least one well controlled comorbidity: cardiovascular disease, chronic lung disease (e.g. COPD, or pulmonary hypertension), immune deficiency (taking the equivalent of 20 mg prednisone daily, chemotherapy, or immune modulating biologic therapies), diabetes (treated with insulin or oral medications), BMI≥30, or hypertension requiring medication with laboratory confirmed SARS-CoV-2 infection (PCR) .\n\n3\\. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use two effective methods of contraception, one of which should be highly effective (as outlined in the protocol). For women, from the first administration of trial treatment, throughout trial and up to 50 days after the last follow up visit (50 days after day 29) and for men with female partners of child bearing potential, from the first administration until 100 days after last follow up visit (100 days after day 29).\n\n4\\. Group B (mild-moderate disease): Ambulant with the following characteristics peripheral capillary oxygen saturation (SpO2) \\>94% RA (NB this differs to the Master Protocol which also includes hospitalised patients in this group).\n\nAdditional criteria specific to this candidate are:\n\n5\\. Has signs or symptoms of COVID-19 that began within 5 days of the planned first dose of study drug.\n\n6\\. Is in generally good health (except for current respiratory infection) and is free of uncontrolled chronic conditions.\n\n7\\. Is willing and able to comply with all study procedures and attending clinic visits through the 4th week.\n\n8\\. Has someone, aged ≥ 16 living in the same household during the dosing period.\n\nCST-6 Additional inclusion criteria:\n\n1. Group A (severe disease). Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, on non-invasive ventilation, or high flow oxygen as defined by the WHO Clinical Progression Scale (WHO, 2020)).\n2. Less than or equal to 14 days from onset of COVID-19 symptoms\n\nCST-8 Inclusion Criteria:\n\n1. For the purpose of CST-8, criteria 1 has been amended from the Master Protocol to:\n\n   Adults (≥18 years) outpatients positive lateral flow test at screening or baseline Day 1, who are within 5 days of symptom onset prior to the planned first dose of study drug.\n2. Criteria 3 has been amended from the Master Protocol to:\n\nWomen of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in section 5.5 of the Master Protocol) for the duration of the treatment and for six weeks following the last dose.\n\nAdditional criteria specific to CST-8 are:\n\n* Initial onset of COVID-19 signs\u002Fsymptoms within 5 days prior to the day of randomisation and at least 1 of the current specified COVID-19 signs\u002Fsymptoms (listed on the NHS website) present on the day of randomisation\n* Is willing and able to comply with all study procedures and attending clinic visits\n\nCST-9a Inclusion Criteria:\n\nFor the purpose of CST-9a, criteria 1 has been amended from the Master Protocol to:\n\n1. Adults (\\>\u002F= 18 years of age) with a positive SARS-CoV-2 lateral flow test on screening or Day 1, who are at high risk (as defined in UK DHSC criteria) of progressing to severe COVID-19 disease, within 3 days of symptom onset, with at least one symptom of COVID-19 infection present on the day of randomization and are with mild- moderate disease severity at enrolment.\n\n   Criterion 2 has been amended from the Master Protocol to:\n2. Ability to provide informed consent signed by trial participant or legally acceptable representative and are willing and able to comply with all trial procedures and attending clinic visits\n\n   Criterion 3 has been amended from the Master Protocol to:\n3. Women of childbearing potential (WOCBP) and male participants who are sexually active with WOCBP must agree to use two effective methods of contraception, one of which must be highly effective for the duration of the treatment and for 90 Days following the last dose\n\nMaster Protocol Exclusion Criteria:\n\n1. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5 times the upper limit of normal (ULN)\n2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2)\n3. Pregnant or breast feeding\n4. Anticipated transfer to another hospital which is not a study site within 72 hours\n5. Allergy to any study medication\n6. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment\n7. Patients participating in another CTIMP trial\n\nN.B. The CST protocol exclusion criteria will take precedence over the master protocol exclusion criteria.\n\nCST-9a Exclusion Criteria:\n\nExclusion criteria has been amended from master protocol as:\n\n1. Prior SARS-CoV-2 infection \\\u003C90 days before enrolment and\u002For received any COVID-19 vaccine dose \\\u003C90 days before enrolment\n2. Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN) or Active Liver disease\n3. History or current evidence of cirrhosis\n4. Receiving dialysis or have known moderate to severe renal impairment (defined as CKD stage 4 or 5) or current acute kidney injury on most recent eGFR in the past 6 months\n5. Pregnant or breast feeding\n6. Anticipated transfer to another hospital which is not a trial site within 72 hours\n7. Known allergy to any trial medication\n8. Swallowing difficulties\n9. Currently receiving ALG-097558, Paxlovid, molnupiravir or remdesivir or any SoC therapy for COVID-19 at the time of screening\n10. Received sotrovimab at any point during the current SARS-CoV-2 infection\n11. Oxygen saturations \\\u003C94% on room air\n12. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.\n13. Participants who have taken or require treatment with a comedication that is a strong CYP450 3A4 inhibitor (atazanavir, clarithromycin, itraconazole, posaconazole, voriconazole, nefazodone, nelfinavir, grapefruit juice, HIV protease inhibitors), strong CYP450 3A4 inducers (rifampin, phenytoin, carbamazepine, St. John's Wort) or sensitive substrates of CYP450 2C8 and 2B6 (repaglinide, rosiglitazone, paclitaxel, bupropion) within at least 2 weeks or 5 half-lives (whichever is longer) before the planned first dose of study drug.\n14. Participating in another CTIMP trial\n\nCST-9b Exclusion criteria:\n\n1. Prior SARS-CoV-2 infection diagnosed \\\u003C90 days before enrolment and\u002For received any COVID-19 vaccine dose \\\u003C90 days before enrolment\n2. Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN) or Active Liver disease\n3. History or current evidence of cirrhosis\n4. Receiving dialysis or have known severe renal impairment defined as CKD stage 5 (an eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m2 at screening, or current acute kidney injury in most recent eGFR in past 6 months.\n5. Pregnant or breast feeding\n6. Anticipated transfer to another hospital which is not a trial site within 72 hours\n7. Known allergy to any trial medication\n8. Swallowing difficulties\n9. Currently receiving ALG-097558, Paxlovid, molnupiravir or remdesivir or any standard of care antiviral therapy for COVID-19 at the time of screening\n10. Received sotrovimab at any point during the current SARS-CoV-2 infection prior to enrolment\n11. Oxygen saturations \\\u003C94% on room air. NOTE: Participants on stable oxygen therapy, including use of NIPPV (non-invasive positive pressure ventilation), for a pre-existing medical condition (e.g., COPD) may be included with oxygen saturation of \\\u003C94% on room air, provided there is no new increased oxygen requirement.\n12. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.\n13. Participants who have taken or require treatment with a comedication that is a strong CYP450 3A4 inhibitor (atazanavir, clarithromycin, itraconazole, posaconazole, voriconazole, nefazodone, nelfinavir, grapefruit juice, HIV protease inhibitors), strong CYP450 3A4 inducers (rifampin, phenytoin, carbamazepine, St. John's Wort) or sensitive substrates of CYP450 2C8 and 2B6 (repaglinide, rosiglitazone, paclitaxel, bupropion) within at least 2 weeks or 5 half-lives (whichever is longer) before the planned first dose of study drug.\n14. Participating in another CTIMP trial within 5 half-lives of the last administered dose of an investigational medicinal product.\n15. Participants eligible for other antiviral treatment according to DHSC criteria, or those otherwise eligible for CST9a.","ALL","18 Years",{"count":292,"type":293},600,"ESTIMATED","INTERVENTIONAL",[296,297],"PHASE1","PHASE2","The AGILE platform master protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols of this master protocol as appendices. Having one master protocol ensures different candidates are evaluated in the same consistent manor and opening up new trials for new candidates is more efficient. Inclusion of new candidates will be based on pre-clinical data, evidence in the clinical setting and GMP capabilities.",[300],"Covid19",[302,303,304,305,306],"SARS coronavirus 2","SARS-CoV-2","Phase I","Phase II","Platform trial","2026-05-27",{"date":309,"type":310},"2026-06-01","ACTUAL",{"date":312,"type":310},"2020-07-03",{"date":314,"type":293},"2027-03-31",{"name":5,"class":6},7]