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Long evidence for COVID begins to pile up, suggesting biomarkers and ‘triangle’ effect – PharmaLive

Long lines of evidence for COVID are beginning to accumulate, suggesting biomarkers and a “triangle” effect.

Posted: July 11, 2022

By Tristan Manalak

Biospace

Scientists at Brigham and Women’s Hospital and Massachusetts General Hospital have found that the presence of the SARS-CoV-2 spike protein in plasma can be a hallmark of prolonged COVID. These results show that the virus can remain in the body of patients who suffer from prolonged symptoms.

The data, published in June on the medRxiv preprint server, revealed that of the 37 participating patients with persistent symptoms, 65% had detectable levels of viral antigens in their plasma samples. The most common of these was the spike protein, which was found in 60% of all long COVID patterns. Meanwhile, the spike protein was absent in the plasma of patients who did not suffer from prolonged symptoms of COVID-19.

A total of 63 patients who recovered from COVID-19 were included in the study. To look for biomarkers associated with long COVID, blood samples were collected at least twice in the year following each participant’s first positive swab. The findings have not yet been peer-reviewed.

Prolonged COVID, more technically called post-acute sequelae of COVID-19, refers to symptoms that persist, recur, or occur months after the patient has cleared the initial infection. These symptoms are very diverse, ranging from prolonged fatigue or coughing to diarrhea, rashes and disturbances in a woman’s menstrual cycle. In some cases, prolonged COVID can even manifest as depression and anxiety or cognitive problems such as brain fog.

While anyone infected with the coronavirus can develop prolonged COVID, those with severe disease as well as unvaccinated patients may be at much higher risk. As such, the United States Centers for Disease Control and Prevention lists immunization as an effective way to prevent post-acute symptoms.

To work alongside the coronavirus vaccines, several companies are developing drugs that target various long-term symptoms of COVID-19. Clinical-stage biotech company Axcella Health is conducting an ongoing Phase IIa study to evaluate its long-acting COVID candidate AXA1125. In preclinical studies, Axcella’s candidate showed promise in reducing markers of insulin resistance, inflammation and fibrosis. Preliminary data from clinical trials are expected later this year.

Axcella is joined by Boston-based PureTech, which is betting on its LYT-100-COV (deupirfenidone), an anti-inflammatory and anti-fibrotic agent, to treat persistent respiratory symptoms after COVID-19. However, the company announced last month that its candidate failed to meet the primary endpoint in phase II and could not demonstrate a significant benefit over placebo. LYT-100 is no longer being developed for long-term COVID and is dedicated solely to idiopathic pulmonary fibrosis.

What’s more, a recent study found that thromboprophylaxis, primarily using Johnson & Johnson’s Xarelto (rivaroxaban), can significantly reduce the incidence of fatal venous thromboembolism, cardiovascular death, and other cardiac complications after recovery from COVID-19. The drug is also largely safe for this indication, causing no bleeding episodes and causing allergic reactions in only 1% of recipients.

Takeda’s Trintellix (vortioxetine), a well-known antidepressant, is also being tested as a treatment for cognitive problems after COVID-19. A phase II randomized, double-blind, placebo-controlled trial is set to enroll approximately 200 participants and quantitatively assess cognitive function using the Digit Symbol Substation Test. The study is expected to be completed later this year.

Also in Phase II evaluations is Genentech’s Esbriet (pirfenidone), which is being tested against pulmonary fibrosis after COVID-19. Enrolling nearly 150 patients, the trial will pit the test drug against a placebo and compare the induced changes in forced vital capacity and pulmonary fibrosis. The study was expected to conclude last month, but no data is available.

Source: BioSpace