ACTIV-3 Phase Aims to Detect Safety of Investigational Drug for COVID-19

Medical experts around the globe are using different technologies to create an effective and safe vaccine to counter the deadly and highly infectious coronavirus disease, COVID-19. The efforts of the researchers are still in the process as no drug has yet been introduced that can beat the novel virus.

The experimental drug for COVID-19 known as ‘mRNA-1273’ has recently entered its phase III clinical trial at 89 different U.S. clinical research sites. Now, the medical health experts aim to administer monoclonal antibody treatments on the hospitalized patients of COVID-19 to check the safety and efficacy of the new investigational drug, says a recent report published by the National Institutes of Health (NIH).

It has been known that the new drug has shown effectiveness and positive outcomes in its phase I and phase II clinical trials. Previous results determined that mRNA-1273 has made antibodies with high levels of virus-neutralizing activity. For further inquiry, the drug has been entered into a randomized and controlled phase III clinical trial which is known as ACTIV-3 or as a “master protocol”.

The current study aims to test the safety and efficacy of the new drug. Therefore, the researchers have aimed to apply monoclonal antibody treatments on those hospitalized patients who are struggling with COVID-19. Monoclonal antibody therapy includes those antibodies that specifically target a certain antigen, such as one found on cancer or coronavirus cells. Furthermore,  they can then make many copies of that antibody in the laboratory.

The team from the present protocol will use an adaptive two-stage Phase 3 protocol design. The study will include two stages of the clinical trial. There will be a flexibility of adding new therapeutic techniques into the stage I or stage II trials.

To check the efficacy of the experimental drug, the researchers will extract the sample that will consist of 300 hospitalized COVID-19 patients with fewer than 13 days of mild or moderate symptoms.

But first, the investigators will study investigational monoclonal antibody LY-CoV555 that was discovered by Abcellera Biologics (Vancouver, British Columbia) in collaboration with NIAID’s Vaccine Research Center. The LY-CoV555 has been found earlier in the blood samples of those patients that have been recovered from the coronavirus. The safety and efficacy of the LY-CoV555 antibody are also being investigated in the ACTIV-2 on the non-hospitalized patient with mild or moderate symptoms of the coronavirus.

However, the team plans to administer the monoclonal treatment and then examine the outcomes for the master protocol.

Source: AstraZeneca

After the selection of the sample based on the study criteria, the team will administer the infusion of LY-CoV555 either intravenously or a saline placebo infusion with a combination of an antiviral drug known as ‘Remdisivir’ for the safety purpose. The medical health professional will examine the study participants after every 5 days for consecutive 90 days from the baseline period.

The Director of NIAID Anthony S. Fauci, M.D. said: “Studying the impact of this investigational therapeutic on multiple patient populations at the same time is critical to determining whether it can help COVID-19 patients with differing levels of disease severity. These concurrent trials have the potential to yield significant and comprehensive clinical data”.

In response of getting the positive results from the stage, I trial the team of the present study will head towards the second stage where they will enroll 700 more severely infected patients with COVID-19 for the double-check to inquire whether the treatment is potentially strong in making antibodies against the deadly coronavirus that has wreaked havoc by making destruction and taking life on a devastating level around the globe.

It has been known from data extracted from the Worldometer that more than 18.7 million people have been sickened due to the deadly coronavirus whereas above 704,000 people have lost their battle against the life-threatening infectious COVID-19.

Source: Reuters Graphics

The current master protocol will be held with the help of two programs. First, the ‘Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program’ which is a public-private partnership to speed development of the most promising treatments and vaccine candidates.

The second support system is ‘Operation Warp Speed’ (OWS) which is the U.S. government’s multi-agency effort to develop, manufacture, and distribute medical countermeasures to fight COVID-19.

The lead network for the current study is the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), operated by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH.

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