"Convalescent plasma with high antibody titers applied in the first days of illness transforms COVID-19 into a bad cold in older people."
"Convalescent plasma with high antibody titers applied in the first days of illness transforms COVID-19 into a bad cold in older people."
A randomized, double-blind, placebo-controlled study conducted by the INFANT Foundation evaluated the efficacy of early administration of convalescent plasma with high antibody titers in older adults with mild disease and observed that its application decreased by 60% the likelihood of these patients needing oxygen during need for oxygen during the illness.
The study, conducted by a team of scientists led by Dr. Fernando Polack (Director of the INFANT Foundation), demonstrated that convalescent plasma administered to infected persons over 65 years of age with comorbidities and to all persons over 75 years of age is effective in preventing COVID-19 from developing into a severe respiratory disease, provided it is administered within 72 hours of the onset of symptoms. within 72 hours of the onset of symptoms. In this way, and in line with the use of plasma derivatives - such as hyperimmune gamma globulin - and antiviral drugs in other diseases - antibody-rich plasma acts at the onset of the disease preventing it from progressing, unlike trials conducted in severe patients where stopping the progression of COVID-19 becomes more difficult and no conclusive benefits have been found in its use. "Plasma is just a vehicle that carries antibodies. Twenty-eight percent of people have, according to our study, the amount of antibodies needed to donate plasma for this treatment. By restricting donors to those with higher antibody concentrations, it is possible to improve the yield of plasma even further. Although this excludes a group of convalescent patients from donation, between 4 and 8 recovered patients have the necessary antibodies to be donors. Patients who have had pneumonia or needed to be hospitalized tend to produce the most antibodies," Polack explained. The researchers identified the desirable amounts of protective antibodies in the plasma bags using the COVIDAR antibody assay developed by the Leloir Institute in Buenos Aires. This information is an extremely important tool for the design of public policies, as it will allow the design of donation campaigns that directly target the right donors, optimizing time, effort and resources. "This study describes the world's first strategy to halt the progression of SARS-COV2 with a cost-effective, universal, off-patent, proven safe intervention that can be administered on an outpatient basis in units of care without the need for hospitalization," said Polack. The trial, which was conducted between last June and October, involved 160 adults over the age of 65 with at least one comorbidity (hypertension, diabetes, obesity, renal failure and/or chronic obstructive pulmonary disease), and all those over the age of 75. The program coordinated the efforts of the public and private sectors, bringing together hospitals in the Province of Buenos Aires and sanatoriums in the Federal Capital, with the support of the respective Ministry and Secretariat of Health, the PAMI, the Military Hospital, various actors in the health area and hundreds of volunteers.
An independent Data and Safety Monitoring Board (DSMB) oversaw the study by monitoring its quality and the well-being of patients. The study was funded by a grant from the Bill & Melinda Gates Foundation and the INFANT Foundation Pandemic Fund, which brings together numerous national companies and private contributors. La investigación se llevó a cabo con la colaboración del Instituto de Efectividad Clínica y Sanitaria (IECS) y la Fundación Hematológica Sarmiento en el Hospital Dr. Carlos Bocalandro, el Hospital San Juan de Dios, el Hospital Simplemente Evita, el Hospital Central de San Isidro Dr. Melchor Ángel Posse, Clínica Olivos and a network of geriatric care units linked to PAMI in the Province of Buenos Aires, and at the Hospital Militar Central, Centro Gallego, Sanatorio de los Arcos, Hospital Universitario CEMIC, Sanatorio Sagrado Corazón, Sanatorio Anchorena and Sanatorio Finochietto in the Autonomous City of Buenos Aires.
The design of this study was randomized, double-blind, and placebo-controlled. This means that half of the patients randomly received high-antibody titer plasma and the remaining half placebo (physiological solution), without physicians or participants knowing which substance was administered to each individual. This method is used to ensure fairness in the evaluation of the results. About the study Once all enrolled patients received plasma or placebo, the evolution of the disease in both groups was compared. Of the patients actually treated with plasma, only 9 required oxygen versus 23 who received placebo treatment. It is estimated that one out of every 6 people treated with plasma who would have had severe disease if they had not received it, did not develop it.
"This is the only study in the world against SARS-COV2 that was done with this rigorous methodology of early comparison of one group against another and, therefore, provides evidence that the disease did not progress due to the administration of the plasma and not for other reasons", explained Dr. Romina Libster, one of the main authors of the study, a pediatric physician specialized in vaccines and researcher at the INFANT Foundation. In order to make this study possible, the work required the detection of plasma donors, the identification of patients in the geriatric centers of the Province and Capital of elderly people with early mild symptoms, their rapid testing at home by swabbing for SARS CoV2 in the laboratory of the Hospital Militar Central, and the transfer of infected people who wished to participate in the study institutions by a mobile group provided free of charge by Swiss Medical, which traveled for months throughout the region. There, a team from the Sarmiento Hematology Foundation coordinated the administration of plasma or placebo, making sure that no one knew who received which product. This was followed by daily monitoring of the participants for up to 25 days and analysis of all the data by a group of research and statistical experts from INFANT and the IECS. In the first weeks of May, against the clock and in the midst of a pandemic with enormous uncertainty, the team of researchers at INFANT researchers trained more than 200 physicians from participating health centers in the protocol. from participating health centers. The goal was to reduce the chances of error in all procedures. At the same time, a large group of volunteers was actively searching for donors. Every day they called a hundred people recovered from COVID-19 to invite them to participate in the program and to make them aware of the importance that this contribution could have for new patients. More than 100 volunteers more than 100 volunteers who helped us day and night in the identification of possible patients to enroll in the study, coming from their homes and nursing homes in the Buenos Aires suburbs, referred through the collaboration of PAMI, or arriving for consultations at clinics in the Federal Capital. "During all the stages, the project, which involved around 400 people, required meticulousness to assemble the different links and cover both scientific and logistic needs", said Gonzalo Pérez Marc, pediatrician and assistant director of the Maternal and Child Department of the Hospital Militar Central and also one of the main authors of the work. This study, carried out with Argentine scientists, is the first evidence in the world of a universal, accessible and safe treatment that may save lives that can save lives until vaccines become available.
