The long-term hostile effects of infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causal agent of the continuing coronavirus disease 2019 (COVID-19) pandemic, are well documented. The manifestation of those symptoms, which is sometimes called ‘long-COVID,’ in severely infected COVID-19 patients has similarly been reported in lots of studies.
Study: Apixaban following discharge in hospitalised adults with COVID-19: Preliminary results from a multicentre, open-label, randomised controlled platform clinical trial. Image Credit: WHYFRAME / Shutterstock.com
Background
Individuals severely infected with SARS-CoV-2 are at a better risk of developing pulmonary and cardiovascular complications, with potentially long-lasting consequences, comparable to persistent inflammation, venous thromboembolism, and pulmonary fibrosis. Several therapeutic approaches have been identified to treat the acute stage of COVID-19; nonetheless, there stays a scarcity of specific therapies able to effectively treating long COVID.
A recent retrospective cohort study that included about 48,000 individuals with acute SARS-CoV-2 infection who were admitted to National Health Service (NHS) hospitals in England revealed that about 29% of those patients had been readmitted, while 12% had died following discharge. An analogous pattern was also observed in one other study based in the USA.
Within the case of severe SARS-CoV-2 infection, coagulation abnormalities were observed, related to platelet activation and clotting aspects. As well as, a high incidence of thromboembolic events was reported throughout the post-acute phase of COVID-19.
On account of inconsistencies in the danger estimation of anticoagulant treatment, an efficient therapeutic decision regarding using anticoagulant drugs couldn’t be made. Due to this fact, itentifying effective pharmacological prophylactic agents able to reducing the danger of venous thromboembolism in COVID-19 convalescent adults is imperative.
The National Institute for Health and Care Excellence (NICE) didn’t discover research that determined the effectiveness and safety of pharmacological prophylaxis to cut back the danger of venous thromboembolism in adults who’ve received take care of COVID-19. Nonetheless, NICE has published some relevant guidelines for the clinical management of COVID-19.
Concerning the study
HEAL-COVID is a recent adaptive, randomized, open-label, multicenter, multi-arm, and multi-stage platform trial that addresses this gap in research. This trial compared the post-hospital treatments to plain care amongst adults who required hospitalization after contracting severe SARS-CoV-2 infection.
Apixaban, an oral direct-acting anticoagulant, was chosen as an arm for the trial. Apixaban was chosen resulting from its oral route of administration, promising safety profiles, and widespread availability. The findings of this study have been recently published on the medRxiv* preprint server.
On this study, follow-up data were obtained through data linkage to routine clinical data sources. Moreover, self-reported data of the patients were collected through an app/web-based system (ATOM5) or telephone calls conducted by the research team.
A complete of 1,194 participants were chosen from NHS hospitals in England, Wales, Northern Ireland, and Scotland between May 19, 2021, and November 21, 2022.
All participants were randomly assigned to 2 groups. One group received 2.5 mg of Apixaban twice each day for 14 days, while the opposite group received standard care, which didn’t involve post-hospital anticoagulants. The patients in each groups were monitored for 12 months.
Study findings
Fourteen days of Apixaban treatment didn’t reduce subsequent hospital readmission or death rates. Moreover, the hospital admission rate remained much like that recorded before the commencement of the COVID-19 vaccination program and the appliance of assorted therapeutics, comparable to Tocilizumab, Dexamethasone, and antivirals.
An increased risk of thromboembolism in the primary 4 weeks after SARS-CoV-2 infection has been reported. This remark is consistent with the HEAL-COVID analytical data, which revealed that almost all venous thromboembolic events occurred throughout the first thirty days of the trial.
In the usual care group, 4 pulmonary embolism cases occurred throughout the first 30 days; nonetheless, this event was not reported within the Apixaban group. Nevertheless, two participants from the Apixaban group required hospital readmission resulting from bleeding throughout the same period.
These findings indicated that standard and anticoagulant treatment’s risk-benefit ratio is finely balanced. Thus, the HEAL-COVID trial didn’t exhibit the general advantages of Apixaban treatment by way of mortality and hospital readmission, even after one 12 months.
In-hospital anticoagulation treatment, together with Rivaroxaban for as much as 30 days, didn’t improve death rates, duration of hospitalization, or oxygen requirements. Notably, in multiple patient cohorts, Rivaroxaban caused a better rate of bleeding than Apixaban.
Conclusions
Fourteen days of post-hospital Apixaban treatment failed to cut back death rates or rehospitalization in adults who’ve recently recovered from severe SARS-CoV-2 infection. Thus, the present study doesn’t recommend post-hospital anticoagulation treatment. Notably, the authors hypothesized that longer treatment wouldn’t provide any additional advantages and would increase the danger of bleeding in these patients.
*Essential notice
medRxiv publishes preliminary scientific reports that should not peer-reviewed and, due to this fact, mustn’t be thought to be conclusive, guide clinical practice/health-related behavior, or treated as established information.