It has been eight months since the US was infiltrated with the deadly Coronavirus disease. There is still no available solid evidence that vaccines and convalescent plasma are effective in combating the virus.
Vaccines that are currently under development are not expected to be in distribution within the year. The need for an immediate and effective treatment form still remains. There are thousands of patients still admitted to hospitals, and with the rising number of cases, the CDCP predicts more than 205,000 deaths in the country by next month.
The clinical trials required for convalescent plasma and monoclonal antibodies to determine safety and efficacy are experiencing delays and lack of volunteers. Several trials have only just recently started because researches early into the pandemic put all attention into the development of pre-existing drugs like hydroxychloroquine, which did not work out.
The typical clinical trial to be conducted is randomized, placebo-controlled, which the “gold standard” for all pharmaceutical drug trials. It measures the levels of effectiveness of the investigated drug compared to a placebo. Throughout the study, the researchers and the volunteers will not have any knowledge of whether a volunteer took a placebo or the investigated drug until results are determined. People are hesitant to volunteer because they do not want to be treated as guinea pigs.
Immunity is the concept that lies behind convalescent plasma and monoclonal antibodies. A substance that mimics the virus is introduced into the body and the system fights it off. Convalescent plasma is the liquid part of the blood carrying infection-fighting cells donated from patients who recovered from the infection, while monoclonal antibodies are synthetically-made versions of those cells.
Thousands of patients who would have been qualified as participants for clinical trials were already treated with convalescent plasma under the expanded access program, are already ineligible to be trial subjects.
NIH funded Vanderbilt University Medical Center with $34 million to conduct a massive clinical trial on convalescent plasma to know if it is effective in treating hospitalized patients. 1,000 patients in 50 locations will be involved in the trial. This form of treatment is difficult to acquire because it has to undergo various testing to ensure its effect in fighting the virus cells, and it is finite due to its reliance on recovered patients and their decision to donate.
The move to approve convalescent plasma as emergency treatment is still under discussion by the US FDA. If granted, hospitals would have complete access to the product. A more thorough process is taken due to some mistakes made in the previous months, revoking the approval for hydroxychloroquine as an emergency drug because of numerous side effects that came along with it.
In terms of monoclonal antibodies, they can be synthesized in the lab. The best antibody cells can be determined from the donated plasma and recreated in volume amounts.
Eli Lilly and Regeneron are two makers working on monoclonal antibodies. The results of both are expected in the later part of the year. If approved, the first doses will be given to high-risk people like medical staff, workers in care facilities, and National Guard troops.
Research studies typically take a lot of time. As of this moment, the need to follow that pace and acknowledge the fact that more rapid measures need to be taken to be able to manage the outbreak. People need to understand the scientific process that needs to be taken and the researchers need to recognize the urgency of the situation.