Clinical Trials Registration ClinicalTrials.gov Identifier: NCT04518410.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10469341 | PMC |
| http://dx.doi.org/10.1093/infdis/jiad246 | DOI Listing |
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Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial.
Pathog Immun
May 2024
Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina.
Article Synopsis
- Outpatient treatment of COVID-19 using subcutaneous monoclonal antibodies (mAbs) could simplify logistics compared to intravenous delivery.
- In a clinical trial with 211 participants, the BMS mAbs did not show significant benefits in symptom improvement or viral load reduction compared to placebo, despite being safe with fewer severe adverse events reported.
- The results suggest that subcutaneous administration of BMS mAbs may not be effective for low-risk COVID-19 patients, potentially due to how the body absorbs mAbs through this method.
Safety and efficacy of inhaled interferon-β1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial.
EClinicalMedicine
November 2023
Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Background: With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need.
Methods: Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.govNCT04518410).
Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial.
J Infect Dis
August 2023
Department of Biostatistics and Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Article Synopsis
- Adaptive platform trials were used during the COVID-19 pandemic to quickly test new treatments, such as the ACTIV-2 trial that looked at seven different investigational therapies.
- The trial used a pooled placebo control group, which included participants receiving either a placebo for the specific agent being tested or for other agents being evaluated at the same time.
- This approach reduced the overall sample size by 6% compared to separate placebo groups and achieved a larger 26% reduction during overlapping evaluations, highlighting the complexities of using pooled versus separate controls in clinical trial designs.
ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients.
J Infect Dis
August 2023
Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Clinical Trials Registration ClinicalTrials.gov Identifier: NCT04518410.
View Article and Find Full Text PDFOne Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial.
Clin Infect Dis
October 2023
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Background: Camostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of camostat in ACTIV-2/A5401, a phase 2/3 platform trial of therapeutics for COVID-19 in nonhospitalized adults.
Methods: We conducted a phase 2 study in adults with mild-to-moderate COVID-19 randomized to oral camostat for 7 days or a pooled placebo arm.
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