The ACTIV-2 clinical study carried out by the Integrated Unit of Clinical Trials (IUPR-CTU) of the Medical Sciences Campus of the University of Puerto Rico (RCM-UPR), is one of the 25 initial units in the United States that carry out This studio. (Sebastiao Moreira)
Along with the frantic search to find a vaccine against COVID-19 , other treatment alternatives are also being developed that help prevent the lethality of the virus. And one of the most promising findings is monoclonal antibody therapy – synthetic copies created in the laboratory from a clone of a specific antibody found in the blood of a person who has recovered from COVID-19 – that could prevent development of a serious illness requiring hospitalization.
This is what is sought to prove with the ACTIV-2 clinical study that began this Monday the Integrated Unit of Clinical Trials (IUPR-CTU) of the Medical Sciences Campus of the University of Puerto Rico (RCM-UPR), one of the 25 units in the United States conducting this study .
“It includes phase II and phase III evaluations of multiple promising agents to treat COVID-19 in a single trial,” explains the study's principal investigator on the island, Dr. Jorge Santana, director of the AIDS Clinical Research Unit ( ACTU, for its acronym in English).
In fact, the infectologist also highlights that people who live in the San Juan area who have recently been diagnosed and are not hospitalized “have the opportunity to make a great contribution by participating in this study.”
According to the scientist, the monoclonal antibody used in this treatment was taken from one of the first COVID-19 patients in Seattle and genetically engineered to be specific against the receptor where the virus sticks.
“It is a selective monoclonal antibody that, in high concentrations, will stick to the virus to prevent it from anchoring in cells. It is much more specific and selective than convalescent plasma ”, says the researcher.
It refers to the fact that in the convalescent plasma currently used in hospitals in patients with COVID-19, the specific concentration of the antibody or immunoglobulin is not as high as in the compound used in this study.
“After seven days, which is the infectious phase, the patient can enter a pulmonary phase in which they can decompensate rapidly. This happens due to an acute inflammatory response in which countless components of the immune system are activated that deteriorate the health of the patient “, the researcher describes, highlighting that there is still no marker in the blood that” can help us predict that a patient with mild to moderate symptoms will develop complications after the first phase of the disease ”.
“I think the vaccine is going to take a long time to solve the problem of the epidemic. Meanwhile, we have to look for therapeutic tools to be able to treat people who are infected. It is what, eventually, can lead to, if a person comes out positive and feels bad, they can use it for about ten days and thus avoid complications or having to be hospitalized. That will be the future six months or a year until the vaccine arrives, “says the researcher.
According to Dr. Santana, it is a study that is the continuation of a smaller one in phase II that involved 452 participants in which it was found that the drug can reduce the need for hospitalization in patients with mild to moderate symptoms in comparison with control patients.
According to the drug's manufacturer, pharmacist Eli Lilly, in that study there was a 72% reduction in the risk of hospitalization among patients who received the monoclonal antibody compared to those who received a placebo.
“The study proved that it lessened complications and prevented 72 out of 100 people from having to be hospitalized. I think that this is a significant and determining fact in terms of the fact that we have a compound that seems to be effective, in addition to the side effects that were demonstrated when you compare it with the one that received a placebo, which is basically a saline infusion, were exactly the same: a feeling of warmth in the arm and dizziness ”, explains Dr. Santana, while highlighting that the efficacy and safety of the study were already proven in the phase I and phase II studies.
“The research will allow us to assess the correlation between changes in viral shedding and clinical outcomes, which will allow us to better understand whether drugs are effective in reducing or stopping the transmission of SARS-CoV-2 (the virus that causes COVID-19 ) to others ”, adds the scientist, after mentioning that the ACTIV-2 study is endorsed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
According to Dr. Jorge Santana, the study protocol is selective and limited. Here are some of the requirements:
– Positive molecular test that is not more than seven days old; have mild to moderate symptoms: fever, aches, malaise, loss of smell or taste.
– Through telemedicine an initial interview is made to the patient to see if he qualifies. After that, you must go for an initial visit to the Medical Center where you will be infused with the medicine (it takes about three hours).
– It is evaluated during the next 12 to 14 days through virtual visits by telemedicine, face-to-face visits to the home and blood samples are collected. This monitoring lasts 28 days.
– The person must have a tablet or a smartphone with which they can have a conversation and evaluation on WhatsApp.
– Those interested in participating should send an email to [email protected]