The ISGlobal Like the two aforementioned hospitals, it works on some fifty projects related to the pandemic and, for now, states that none have stopped due to the lack of new Covid-19 patients. Regarding the ivermectin study, it keeps the recruitment of affected people open, “but hthere are so few new cases that it is difficult to recruit patients” The project seeks to confirm the efficacy of the drug to reduce the transmission of SARS-CoV-2 in a randomized trial in 24 patients with mild disease and less than 48 hours from the presentation of symptoms; that is, new patients.
At Bellvitge Hospital, also in Barcelona, they have a similar problem: “There are projects that depend on new patients and that have not stopped due to the difficulty in recruiting them, but they have slowed down and the deadlines have been lengthened a little. They will not be canceled in any case; will be done with the patients that can be recruited, which will surely qualify the results. In the case of projects related to sequels, they can be done as planned because they do not depend on new patients. ”
Authorized sources of GrifolsFor their part, they have ensured that, as regards their research projects on Covid-19, they are still ongoing in all the participating centers, but that “recruitment is low” Despite which, “none has stopped“They insist. Grifols recently announced that he had started viral convalescent plasma inactivation (with methylene blue) for transfusion, as part of a company-led 100-patient clinical trial for which recovered Covid-19 patients were already donating their plasma. The trial includes six hospitals: in Barcelona, Bellvitge and Valle de Hebrón; in Madrid, the San Carlos Clinic, La Paz and the Jiménez Díaz Foundation, and in Santiago de Compostela, the Santiago University Clinic. Grifols is also leading two more clinical trials in Spain with existing plasma-derived treatments: one trial with high doses of intravenous immunoglobulins in one hundred patients with 6-hop Covid-19, and another with alpha-1 antitrypsin, also in one hundred other patients with 4 hospitals.
La Paz ‘reorganizes’ studios
Alberto Borobia, specialist in Clinical Pharmacology and Coordinator of the Clinical Trials Unit of Hospital La Paz, in Madrid, reports that at the end of April they had 38 clinical trials registered at the center, seven of them from the pharmaceutical industry. “Unlike other centers we have filtered the proposals (they have come to have on the table 27 proposals for industry tests) so that they do not compete with each other, and we have sought a balance between academic and industry tests.” We have also classified them according to mild and severe patients, with more inflammation or more viral load, etc. “As the number of arriving patients has been reduced, we have reorganized the studies with a view to a possible second wave in autumn-winter“, He says. “The phenomenon is parallel to that of other seasonal infections such as influenza or respiratory syncytial virus: we try to catch the maximum peaks,” he adds. At their center, they had no recruitment problems since almost all the patients had volunteered to participate in the trials.
He estimates that they have received close to a million euros from Carlos III to finance trials and have for studies one of the main cohorts in Europe: 3,500 patients included (many already cured or deceased), with those who have studied drugs or are on it. Most of the trials are with drugs, although they have others with cell therapy, T lymphocytes, NK cells, plasma (Grifols) … Think that from June-July the trials will be devoted to testing vaccines, which logically is tested in healthy people.
Trials are being done with drugs already on the market and with new developments and, in his opinion, those of the industry have an advantage because, “although there are now few patients here, they can continue studying their drugs in other countries that now have many patients, such as the South Americans”.
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