2024
A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19
Seethamraju H, Yang O, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha J, Ojha S, Hansen S, Arman A, Lalezari J. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clinical Therapeutics 2024 PMID: 39353749, DOI: 10.1016/j.clinthera.2024.08.019.Peer-Reviewed Original ResearchMild to moderate COVID-19National Early Warning Score 2SARS-CoV-2 infectionPost hoc analysisSARS-CoV-2Randomized placebo-controlled trialHoc analysisHuman IgG4 monoclonal antibodyModerate-to-severe diseaseViral replicationHIV-1 infectionPlacebo-controlled studyProduction of pro-inflammatory cytokinesExcessive production of pro-inflammatory cytokinesMild-to-moderateAdverse event ratesExploratory post hoc analysisTotal symptom scorePathophysiology of SARS-CoV-2 infectionPro-inflammatory cytokinesHeightened immune responsePathophysiology of COVID-19IgG4 monoclonal antibodyPlacebo groupDouble-blind
2023
Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO)
Tuan J, Sharma M, Kayani J, Davis M, McManus D, Topal J, Ogbuagu O. Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO). BMC Infectious Diseases 2023, 23: 258. PMID: 37101135, PMCID: PMC10130811, DOI: 10.1186/s12879-023-08198-9.Peer-Reviewed Original ResearchConceptsCOVID-19 patientsPregnant womenClinical outcomesEmergency departmentPositive SARS-CoV-2 testAdverse feto-maternal outcomesIntensive care unit admissionMild-moderate COVID-19Pregnant COVID-19 patientsPrimary composite clinical outcomeSARS-CoV-2 testComplete primary vaccinationComposite clinical outcomeCare unit admissionFeto-maternal outcomeMedical record reviewSARS-CoV-2 treatmentBetter clinical outcomesBody mass indexSickle cell diseaseCOVID-19SARS-CoV-2Neonatal complicationsPrimary vaccinationUnit admission
2022
Long-term quantitative assessment of anti-SARS-CoV-2 spike protein immunogenicity (QUASI) after COVID-19 vaccination in older people living with HIV (PWH)
Tuan JJ, Zapata H, Barakat L, Andrews L, Behnegar A, Kim YW, Kayani J, Mutic S, Ryall L, Turcotte B, Critch-Gilfillan T, Zhao M, Salahuddin S, Gupta S, Sutton R, Friedland G, Emu B, Ogbuagu O. Long-term quantitative assessment of anti-SARS-CoV-2 spike protein immunogenicity (QUASI) after COVID-19 vaccination in older people living with HIV (PWH). BMC Infectious Diseases 2022, 22: 744. PMID: 36131232, PMCID: PMC9491266, DOI: 10.1186/s12879-022-07737-0.Peer-Reviewed Original ResearchConceptsT cell responsesAnti-spike IgGVisit 3SARS-CoV-2Older PWHVisit 2Immune responseSingle-center longitudinal observational studyVirus-specific T cell responsesVaccine-induced humoral immunityLong-term protective immunityT cell immune responsesOlder peopleMedian age 61RBD IgG levelsPrimary study outcomeCOVID-19 vaccinationImmune response evaluationLongitudinal observational studyCOVID-19 vaccineWilcoxon signed-rank testBNT162b2 boosterBNT162b2 vaccinationCD8 responsesDetectable CD4Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study
Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. The Lancet Infectious Diseases 2022, 22: 636-648. PMID: 35090638, PMCID: PMC8789245, DOI: 10.1016/s1473-3099(21)00764-7.Peer-Reviewed Original ResearchConceptsHigh-dose groupLow-dose groupMedium-dose groupGeometric mean titresAdverse eventsRecombinant protein vaccineCOVID-19 vaccineSecond vaccinationSARS-CoV-2Day 36Antigen doseAdverse reactionsProtein vaccineMedical conditionsVaccine-related serious adverse eventsHigh-risk medical conditionsInteractive response technology systemAntibody geometric mean titresPre-existing medical conditionsCandidate vaccine formulationsCoV2 preS dTMPrevious phase 1Primary immunogenicity objectivePseudovirus neutralization assayUnsolicited adverse events