Color scanning electron micrograph of SARS-COV-2 virus particles (yellow) infected apoptotic cell (red), isolated from patient sample. Image from the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID
The National Institutes of Health’s Institute of Allergy and Infectious Diseases (NIAID) launched a study on October 13, 2020, to determine if there were certain valid therapies or diagnostic drugs promised at the late-stage clinical development show. COVID-19 And enhancement of competence in large clinical trials. The Active-5 is a large-impact trial that will cover 40 U.S. The sites will register adult volunteers admitted to the hospital with COVID-19, in collaboration with NIH’s public-private partnership Accelerating Covid-19 Therapeutic Innovation and Vaccination (ACTIV) program. .
“The purpose of the Active-5 / BET study is to streamline the way to find urgently needed COVID-19 treatments by either re-determining licensed or end-stage-development drugs and testing them to identify the most promising agents for large clinical studies. The fastest way possible, ”said Francis S. Collins, MD, Ph.D., director of NIH.
Phase 2 adaptive, randomized, double-blind, placebo-controlled trials will compare different investigative treatments with a general control arm to determine which experimental treatments have relatively large effects. Approximately 100 hospitalized volunteers will be assigned to each of the study locations, along with more than three investigative tests simultaneously.
“The goal here is to identify as quickly as possible the experimental therapies that demonstrate the clinical promise of COVID-19 treatments and move them into large-scale testing,” said Anthony S., director of NIIAD. “This study design is both an effective way to find promising treatments and to overcome the lack of them,” said Fawcett, MD.
The monoclonal antibody, developed by Bohringer Ingelheim (Ridgefield, Connecticut) and ABVV (North Chicago, Illinois), will be compared to the placebo plus remedivator. The ACTIV-5 / BET trial will also test the monoclonal antibody lenzylomb, developed by Humanigan (Burlingham, California) with placebos and rimadesivir. Rimdesivir has demonstrated clinical benefits for patients with severe COVID-19 who require supplemental oxygen oxygen and is considered the standard of care for hospitalized COVID-19 patients.
Monoclonal antibodies are laboratory-made versions of proteins produced by the immune system in response to an invading virus or other pathogen. Rezanzizumab was approved in the United States in 2019 for the treatment of severe plaque rhinitis. Lanzilumab is currently being tested separately in a Phase 3 COVID-19 study and in a 1B / 2 study as a treatment, respectively, with CAR-T treatment.
In the Active-5 / BET study, volunteers assigned to receive risonquizumab would be given a single intravenous dose on the same day of the study. Study participants assigned to receive lanzilumab will be given 600 mg intravenous infusion for a total of three doses every eight hours.
The main objective of the Active-5 / BET study is to evaluate the clinical efficacy of different screening treatments involving adult control hands admitted to the hospital on the eighth day based on the clinical condition of the volunteers. A secondary point of evaluation of the study is the evaluation of the clinical efficacy of various voluntary therapies based on how long it takes each volunteer to recover from COVID-19.
Study volunteers will be evaluated daily by clinical staff upon admission to the hospital. Once discharged, volunteers will make outpatient visits for 15, 22 and 29 days, possibly by phone if there are infection control concerns or other restrictions. All volunteers will go through a series SARS-CoV-2 Tests, including serum testing and Plasma Samples and oropharyngeal swabs were given on day one of the study before receiving treatment therapy and again on days three, five, eight and 11, when hospitalized. These tests will be repeated on the 15th and 29th whether the study volunteer is hospitalized or gives outpatient clinical follow-up.
The study staff will monitor volunteers for adverse events, and the Independent Data Security Monitoring Board will oversee the trial and conduct periodic reviews throughout its duration.
For more information about the ACTIV-5 / BET trial, please visit ClinicalTrials.gov using the NCT04583969 identifier.
