Phase 3 N=201 Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection
Adenovirus Infection
Primary: Number of Participants With All-Cause Mortality — 9; 27; 8 Participants
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N/A N=128 A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Conjunctivitis
Primary: Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. — 90; 96 percentage of cases
N/A N=28 Reducing Adenoviral Patient Infected Days
Conjunctivitis · Adenoviral Conjunctivitis
Primary: Percent Change From Peak Viral Load — 1.9; 13.2 Percent of peak Viral Load — p=0.02
Phase 2 N=52 Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease
Adenovirus Disease
Primary: Number of Participants With Clinically Significant AdV Infection — 3; 6; 6 Participants
Phase 1 N=12 Safety Study of Adenovirus/PNP Coupled With Fludarabine Phosphate to Treat Solid Tumors
Head and Neck Cancer
Primary: Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment — 12; 8; 8; 5 participants
Phase 2 N=30 Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
Norovirus Infections
Primary: Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay — 1.3; 0.5; 0.3; 127.6 Spot Forming Units per 10^6 PBMC
Phase 3 N=4,040 A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Respiratory Tract Diseases
Primary: Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort — 1; 48 participants
Phase 2 N=3 Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer
Pancreatic Adenocarcinoma · Ovarian Cancer · Biliary Carcinoma
Primary: Safety: Toxicity Symptoms Graded According to CTCAE v4.03. — 61; 139; 411; 7 Number of Events
Phase 3 N=1,756 Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Enterovirus · Rhinovirus
Primary: Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint) — 122.5; 137.1 hours — p=0.4009
N/A N=33 The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Upper Respiratory Infection · Common Cold
Primary: Local Leukotriene Levels — 440; 368; 440; 619 pg/ml
Phase 1 N=41 COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
Covid19
Primary: Number of Participants With Medically Attended Adverse Events (MAAE) — 0; 0; 0; 1 Participants
Phase 1 N=4 Challenge Infection of Healthy Adult Volunteers With RSV A2
Upper Respiratory Tract Infections
Primary: Participants With Detectable RSV Shedding in Nasopharyngeal Wash — 2; 4 Participants
Phase 2 N=38 A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
Respiratory Syncytial Virus
Primary: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination — 2; 6; 11; 17 Participants
Phase 2 N=179 A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
Influenza
Primary: Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus — 17; 19; 15…
N/A N=190 Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Common Cold
Primary: Interleukin-8 (IL-8) — 133; 122 pg/ml
N/A N=26 Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic
Asthma
Primary: Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection — 8.72; 2.77 units on a scale — p=0.049
Phase 2 N=63 An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults
Healthy
Primary: Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) — 0; 236…
Phase 4 N=339 Fall Epidemic Viral Pediatric Study
Asthma
Primary: Total Number of Asthma Exacerbations Reported During the Treatment Period — 24; 25 Number of asthma exacerbations — p=0.928
Phase 2 N=38 Clinical Response to Rhinovirus Challenge
Asthma · Allergic Rhinitis
Primary: Change in Symptom Scores Induced by the Rhinovirus Using Jackson Criteria Including Nasal Congestion, Drainage, Cough, Wheezing — 5.0; 4.2; 2.8 score on a scale
Phase 2 N=4 ARMS - Rapidly Generated Multivirus-Specific CTLs for Prophylaxis & Treatment of EBV, CMV, Adenovirus, HHV6 & BK Virus
Viral Infection
Primary: Number of Participants With a DLT — 0; 0; 0; 3 Participants
N/A N=58 The Development of a Human Model of Respiratory Syncytial Virus Infection
Respiratory Syncytial Virus Infections · Respiratory Viral Infections
Primary: Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid — 23 Participants
Phase 1 N=40 Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
Ebola Virus
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration — 3; 3; 6; 16 Participants
Phase 1 N=40 cAd3-Marburg Vaccine in Healthy Adults
Marburg Virus Disease
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration — 9; 4; 13; 10 Participants
Phase 2 N=10 MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID
Severe Combined Immunodeficiency
Primary: Number of Participants With Adverse Events — 10; 9; 0; 10 participants
N/A N=48 Cohort Isolation and Cross-infection in Bronchiolitis
Bronchiolitis
Primary: Duration of Hospital Stay — 3.9; 2.1 days
Phase 3 N=25,236 A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Respiratory Syncytial Viruses · Lower Respiratory Tract Disease
Primary: Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower…
Phase 1 N=32 Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age
Respiratory Syncytial Virus Infections
Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade — 17; 9; 3; 1 Participants
Phase 1 N=95 Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Influenza
Primary: Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization. — 3; 3; 5; 0 Participants
Phase 2 N=180 A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health
Healthy
Primary: Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains — 215; 168…
Phase 2 N=21 RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Upper Respiratory Tract Infection · Lower Respiratory Tract Infection
Primary: Circulating RI-001 Titer — 9.24; 4.85; 1.42 Fold Change