Health centers in Galicia and Catalonia are distributed to the nearly 120 Covid-infected patients who participate in a clinical trial to test a drug against mild and moderate symptoms of the disease. It is the first Spanish oral drug for the treatment of coronavirus, a “pioneer” drug that is still in the study phase but was presented yesterday at the Santiago Health Research Institute (IDIS), located at the Compostela Clinical Hospital, and that has the approval of the Spanish Medicines Agency. Under the name ‘SIMGA4 Covid’, the co-director of the study, Mabel Loza, indicated that the trial is included among the dozen worldwide with these characteristics and that it has already “passed phase 1 in human safety,” the researcher introduced as a letter of presentation of a drug that is already being tested at the A Estrada health center.
The implications of the treatment of patients with a mild to moderate pathology, circumscribed to their family doctor, gave rise in this trial to an “innovative” activity in which Primary and Hospital Care professionals from both autonomous communities collaborate in a work of ” high impact in the field of health”, as indicated yesterday by the director of IDIS, María Luz Couce.
The drug under study was initially developed for the treatment of neuropathic pain, that is, pain that interprets sensory stimuli that are normal as painful, but its benefits in the face of a Covid infection seem evident. The patients who participate in this phase voluntarily agree to be exposed to the drug, which is associated with an improvement in Covid symptoms in cases that do not require hospitalization. To verify this, two groups of infected were created. The first is given a standard treatment for Covid plus a dose of the study drug for a period of 14 days. The second, a control, is only given the classic treatment against the infection, plus a placebo. Regarding the conditions of the trial, the researchers involved explained that the primary care physicians do not know which people are receiving the new treatment and which are receiving the placebo, so that there is no type of interference in the final results.
The objective, after these two weeks, is to detect if the viral load presented by the infected decreased “significantly”, which would lead to preventing clinical deterioration and possible complications of the infection. And it is that the functions of the new drug, clarify from the Idis, are based on the fact that it interferes with viral replication in the host cell, which slows down the multiplication not only of the coronavirus, but of other RNA viruses. On the side effects on the patient’s health, the head of pharmacy at the Clinical Hospital, Irene Zarra, commented that they are working to make the drug “safe and effective”, after indicating that it is based on a “safe molecule that is well tolerated” , with “mild” adverse effects such as “dizziness and headache”.
To find it, Loza pointed out that the Biofarma group in which he participates in Galicia had studied a thousand drugs that “could be used” before staying with this one, which “was the one with the best profile.” The goal, the participants in the presentation agreed, is to obtain an oral medication for the “treatment in the first days of infection” of Covid-19 with the aim of “avoiding viral replication” in cells. For this reason, in the case of demonstrating that this drug “decreases the viral load”, the researcher pointed out that “it would be necessary to continue in more patients” than the 120 -of them between 30 and 50 in Galicia- of the study “in order to validate it” . The importance of the project was highlighted by the Minister of Health, Julio García Comesaña. “This is an important day for Galician and national health”, he said to highlight the participation of researchers and clinicians from the Compostela area, in which “296 studies” are currently being carried out.
