[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Code Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100568068","phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-codivir-in-addition-to-standard-antiretroviral-treatment-for-hiv-infection-in-antiretroviral-nave-participants-100568068",false,"NCT06676410","Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants","Codivir®","Inclusion Criteria:\n\n1. Male or female sex;\n2. Age ≥ 18 years;\n3. HIV infection confirmed by serology (Ab for HIV1\u002FHIV2) and HIV1\u002FHIV2 RNA test;\n4. Naive for antiretroviral treatment;\n5. Viral load \\> 1,000 and \\< 50,000 copies\u002FmL;\n6. CD4 T lymphocyte (CD4) cell count \\>350 cells\u002Fmm3;\n7. Body weight at V -1 \\> 50 Kg;\n8. Signature of the ICF.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation or plan to become pregnant;\n2. BMI \\< 18.5 kg\u002Fm2 at screening;\n3. Coinfection with HBV (HBSAg +) or HCV;\n4. Any Grade 3 or 4 clinically significant abnormality according to the Division of AIDS (DAIDS)\\* rating scale;\n5. Any significant acute illness within 1 week before V0.\n6. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening;\n7. Active malignancy or ongoing malignancy;\n8. Changes in safety tests: neutrophil count \\< 1000 u\u002FL; Hb \\< 9.0 gm\u002Fdl; platelet \\< 75,000 u\u002FL; creatinine \\> 1.5 mg\u002Fdl, direct bilirubin \\> 85 μmol\u002Fl, AST or ALT \\> 2.5 X ULN;\n9. Potential allergy or hypersensitivity to components of the Codivir® formulation.\n10. Participation in another clinical trial within 12 months of screening.\n11. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study will begin with a two-week lead-in period (W-2 and W-1), when participants randomized to Codivir® will receive Codivir® 2 mL, 1 subcutaneous injection every day. Participants randomized to Standard Antiretroviral Treatment will wait for the next step.\n\nAt V0 (W0, D0) all participants will start the antiretroviral treatment described above.\n\nFrom V0 (W0, D0) to V6 (W12, D84) participants randomized to Codivir® will receive Codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day).\n\nAt V6 (W12, D84) treatment with Codivir® will end. At V7 (W24, D168) participation in the study will end. Viral load will be monitored during the study. In case of failure, participation in the study will be discontinued and the participant will be referred to receive the best treatment available for their case.",[26,27],"HIV","HIV Infection",[26,29],"AIDS","RECRUITING","2024-11-04",{"date":33,"type":34},"2024-11-06","ACTUAL",{"date":36,"type":34},"2023-07-20",{"date":38,"type":20},"2024-12",{"name":40,"class":41},"Code Pharma","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100456037","phase-2-phase-iia-randomized-placebo-controlled-clinical-study-of-codivir-in-hospitalized-patients-with-moderate-covid-19-100456037","NCT05218356","Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Male or female\n* SARS-CoV-2 infection indicated by confirmed RT-PCR test\n* Moderate hospitalized COVID-19 (at least two out of three criterias below):\n\n  * Evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (X-rays)\n  * Oxygen saturation (SpO2) in room air \\\u003C 93%\n  * \\\u003C30 breaths per minute\n* No signs of hemodynamic decompensation\n* Absence of pregnancy in women of childbearing age\n* Ability to understand and comply with the requirements of the protocol\n* Consent to participate\n* Consent to use at least one highly effective contraception methods (condoms, IUD, oral contraceptives) since the ICF signature and at least 30 days after the study.\n\nExclusion Criteria:\n\n* Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are allowed to be enrolled to the study).\n* Positive RT-PCR test more than 72 hours prior to enrolment.\n* Onset of symptoms more than 7 days prior to enrolment.\n* Participant using drugs that are under clinical investigation in last 30 days.\n* Body mass index less than 19.9 or greater than 35.\n* Comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and \u002F or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study.\n* Concomitant HIV, HBV or HCV infection.\n* Pregnancy or lactation.\n* Vaccination for any other infection in the 4 weeks prior to enrolment.\n* Any condition that increases the risk of participating in the study, in the opinion of the investigator.","75 Years",{"count":51,"type":20},130,[23],"This is a double-blind, multicentre, multinational study to evaluate the safety and collect preliminary efficacy data of Codivir drug product in 130 hospitalized adults with moderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smell or taste) onset must be within 7 days prior enrolment. Treatment will begin in the hospital, participants will be discharged according to medical decision and continue the treatment until to Day 7 at home and followed up to day 28.",[55],"COVID-19","2024-10-01",{"date":58,"type":34},"2024-10-02",{"date":60,"type":34},"2022-01-20",{"date":62,"type":20},"2025-07-20",{"name":40,"class":41},5,""]