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An International Observational Study of Outpatients With SARS-CoV-2 Infection (ICOS)
Rochester, Minn.
The general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations, special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-Cov-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment. Secondary outcomes include participant-reported health status and change in severity of dyspnoea.
Closed for Enrollment
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A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTIV-5 / BET)
Jacksonville, Fla.,
Rochester, Minn.
The primary objective of this study is to evaluate the clinical effectiveness of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
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A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia (HGEN003-06)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.
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A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating the Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients with Serious Influenza A Infection
Rochester, Minn.
The purpose of this study is to determine the optimal dose of FLU-IGIV based upon evaluation of safety and pharmacokinetics in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection.
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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis (DISRUPT)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of Exebacase, in addition to standard of care antibiotics (SoCA), compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE).
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A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults (20-004930)
Rochester, Minn.
The purpose of this study is to test (in 2 stages) the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in HIV-1 infected participants undergoing antiretroviral therapy (ART) interruption.
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An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-Transplant Patients Treatment for C. Difficile Infections (CDIFF)
Rochester, Minn.
The purpose of this study is to estimate the success, recurrence, and complications over the 90 day follow up period for the treatment of C. difficile infection in adult solid organ or stem cell transplant patients.
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Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Rochester, Minn.
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
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Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)
Rochester, Minn.
The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.
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INSIGHT Genomics Study
INSIGHT Protocol No.004 version 2.0, dated 27 August 2013
Rochester, Minn.
The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other geneticvariants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
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VC-02-01, A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients with Advanced Coronavirus Disease 2019 (COVID-19) (VC-02-01)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This study will evaluate the efficacy of merimepodib (MMPD) administered orally every eight hours (q8h) for 10 days in adult patients with advanced COVID-19.
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