From September 6 to 18, equine antibodies were administered to 27 participants, thirteen received formulation A and fourteen were treated with formulation B. Ten were women and 17 men, in an age range of 31 to 77 years.
The intervention was applied in four research sites: San Juan de Dios hospitals, 10 participants, Mexico hospital, six, Calderón Guardia hospital, five, and n the Specialized Attention Center for COVID-19 Patients (CEACO) with six.
At the time of incorporation to the study, 17 participants showed moderate manifestations of the pathology and in 10 cases there were severe cases. After the administration of the product, drowsiness is the most common manifestation in the majority, which could be related to pre-medication according to the researchers.
By this October 1, 16 (59.2%) participants had graduated and remain in the follow-up period at home. The average age of these participants is 55.9 years and 75% (12) presented a moderate manifestation of the pathology at study entry.
The average total hospital stay of these patients who were discharged home was 10.1 days and the hospital stay after the administration of the research product was 7.2 days. There was only one readmission for an event not related to the investigational product.
Of the total discharges, formulation A was administered in eight cases and preparation B in the other half.
Participants who were discharged with a severe manifestation of covid-19 had an average hospital stay of 3 days longer and an average age of 10 years younger than patients recovered with moderate criteria.
Sanabria and Bujan indicated that, of the total of 27 participants, thirteen serious adverse events were reported, which “in 84% are not related to the research product.”
Regarding serious adverse events, 88% are related to the evolution of the pathology and its complications, which include: the need to use assisted mechanical ventilation due to worsening of the Respiratory Distress Syndrome produced by covid-19, superinfections bacterial and septic shock.
In the context of clinical studies, an adverse event is defined as any unfavorable medical occurrence in a person who is administered an investigational product and that does not necessarily have a causal relationship with this treatment, explained Buján.
These events are classified as related, unrelated, possibly related, and causality unknown, he added.
Both researchers mentioned that these events include medically important reports of progression of the disease and may or may not be expected.
In this biomedical research, reported possibly related adverse events are expected and correspond mainly to allergic reactions, the doctors said.
“Unfortunately, Sanabria indicated,“ six study participants died due to disease progression or complications. These participants had an average age very close to 70 years and the presence of multiple comorbidities that compromised their state of health ”.