“We investigate alternatives for immunocompromised patients with Covid-19”

How does COVID-19 affect immunosuppressed patients? What consequences would it have on their underlying pathology?

These patients comprise a heterogeneous group of conditions (from autoimmunity, organ transplantation, neoplasm, hematologic malignancies, immunodeficiency). This is a population with a relatively high risk of infection with SARS-CoV-2. Therefore, they will be a vulnerable group of people infected with this coronavirus and are likely to continue to suffer the consequences of infection during the current stage of the epidemic. We mainly discuss two consequences, first, that SARS-CoV-2 may cause a subgroup of patients to develop severe pneumonia (Covid-19) at different times during the course of their underlying disease, despite a correct vaccination program . The morbidity and mortality rate of this new coronary pneumonia is very high. Second, it often involves changes in chronic immunosuppressive therapy or deferring scheduled chemotherapy or immunotherapy for patients with active cancer, which may also negatively affect the prognosis of their disease in the medium term. Therefore, despite the improved epidemiological situation, studies in immunocompromised COVID-19 patients are still needed.

Is there a cure for these Covid-19 patients?

We have several antivirals that depend on two variables: the oxygen therapy support the patient needs when they contact the health system, and the time (in days) over which symptoms evolve. These antivirals are recommended during the first days of symptoms and when the patient requires oxygen therapy support. We also have monoclonal antibodies, although they are used less and less due to the emergence of variants with different in vitro resistance. We are also studying other antiviral drugs, in particular a drug from Spain that is in Phase II Nereida clinical trials.

Can you briefly explain what this investigational antiviral is made of and how it is used in this setting?

It is a drug isolated from the Mediterranean tunicate Aplidium albicans. So far, approved and available antiviral drugs have been developed to inhibit/block the action of various viral enzymes and proteins required for efficient replication of SARS-CoV-2. Compared with other approved antiviral drugs, its biggest difference lies precisely in its mechanism of action, which has shown effective antiviral activity against viruses in vitro and in animal models.

Why did you decide to study its use in immunosuppressed COVID-19 patients?

Following the completion of Phase I-II clinical trials of the therapy, the pandemic continues to present epidemiological waves. In the context of limited availability of antiviral therapy, health authorities in our country have approved this antiviral drug for compassionate use. Compassionate use of medicines is specifically regulated through controls by originators and health authorities.

just posted a International Journal of Infectious Diseases study about. Can you tell us its main conclusions?

The main conclusion of this retrospective study is that the use of the investigational antiviral drug in cancer patients has similar Security Data. Solid and hematological malignancies, including active cancer and survivors and patients in remission, and moderate to severe COVID-19 patients (including the percentage of cases that evolved more than 14 days from the onset of symptoms of viral infection; even in more than 14 days) 30 days, with persistent viral pneumonia symptoms). Furthermore, it should be noted that this series of cases, partly communicated at scientific meetings, has been the basis for the design and launch of the Nereida trial.

“Our next step is to enroll patients in the Nereida trial as quickly as possible”

What is the job number?

Compassionate use was performed in accordance with current national regulations, with a retrospective design including clinical data from 35 patients with active or surviving cancer at three hospitals in Madrid (Hospital Chiron de Madrid, Hospital Sancinaro and Hospital HLA Moncloa) . Therefore, this is a study in which only Spanish hospitals participated. The study period of the report covers from the beginning of 2021 to the end of 2022. We are working with other hospitals in the country to update case and clinical data for patients treated after these dates.

What are the next steps?

There is no doubt that patients (despite the epidemiological conditions are not ideal) should be recruited into the Nereid trial as soon as possible. This is related to the following reasons. The first, and I think the most important one, is that this is a trial designed for immunosuppressed Covid-19 patients (there are only two other ongoing in the world). Second, this is a multicentre trial in several European countries that will compare the 30-day all-cause mortality of different antiviral therapies. As a result, we have access to richer, more precise, and more reliable scientific information on the efficacy of SARS-CoV-2 in immunosuppressed populations.