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No participants had received a COVID‑19 vaccine or been previously infected with COVID‑19. [12] The main outcome measured in the trial was the proportion of people who were hospitalized due to COVID‑19 or died due to any cause during 28 days of follow-up. [12] EPIC-HR started in July 2021, and completed in December 2021. [51]
The thrombosis events associated with the COVID‑19 vaccine may occur 4–28 days after its administration and mainly affects women under 55. [6] [2] [20] Several relatively unusual types of thrombosis were specifically reported to be occurring in those with the reaction: cerebral venous sinus thrombosis and thrombosis of the splanchnic veins.
During the COVID-19 pandemic, drug repurposing is the clinical research process of rapidly screening and defining the safety and efficacy of existing drugs already approved for other diseases to be used for people with COVID-19 infection.
The results come a week after the company withdrew its COVID-19 vaccine, one of the first and most widely used, citing a "surplus of available updated vaccines" since the pandemic.
In March 2022, Ocugen registered a Phase 2/3 trial for 400 people in the US to compare the immune responses to those in people in the Indian phase 3 trial, as well as safety and tolerability. [44] The trial also aims to assess the vaccine as a booster after other Covid vaccines used in the US.
The most common side effect in people with COVID‑19 is nausea. [143] Side effects may include liver inflammation and an infusion-related reaction with nausea, low blood pressure, and sweating. [153] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [154]
[73] [74] Some of the people acutely ill with COVID-19 experience deterioration of their lungs and acute respiratory distress syndrome (ARDS) and/or respiratory failure. Due to the high risk of death, urgent respiratory support including mechanical ventilation is often required in these people. [75]
In the European Union, the combination is indicated for the treatment of COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb) who do not require supplemental oxygen and who are at high increased risk of progressing to severe COVID‑19; [10] and for the prevention of COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms ...
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