COVID-19 Treatment: Investigational Drugs and Other Therapies
Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), which was first identified amid an outbreak of respiratory illness cases in Wuhan City, Hubei Province, China.
It was initially reported to the World Health Organization (WHO) on December 31, 2019. On January 30, 2020, the WHO declared the COVID-19 outbreak a global health emergency.
On March 11, 2020, the WHO declared COVID-19 a global pandemic, its first such designation since declaring H1N1 influenza a pandemic in 2009.
Utilization of programs established by the FDA to allow clinicians to gain access to investigational therapies during the pandemic has been essential.
The expanded access (EA) and emergency use authorization (EUA) programs allowed for rapid deployment of potential therapies for investigation and investigational therapies with emerging evidence.
As of October 22, 2020, Remdesivir, an antiviral agent, is the only drug fully approved for treatment of COVID-19. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. An emergency use authorization (EUA) remains in place for treat pediatric patients weighing 3.5 kg to less than 40 kg or children younger than 12 years who weigh at least 3.5 kg.
An EUA for convalescent plasma was announced on August 23, 2020. The FDA issued an emergency use authorization (EUA) for outpatient monoclonal directed therapies ( casirivimab plus imdevimab, bamlanivimab plus etesevimab) for individuals who test positive and are at high risk of severe COVID-19 or hospitalization.
Baricitinib was issued an EUA on November 19, 2020 for use, in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients aged 2 years and older who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The WHO developed a blueprint of potential therapeutic candidates in January 2020. WHO has embarked on an ambitious global “megatrial” called SOLIDARITY in which confirmed cases of COVD19 are randomized to standard care or one of four active treatment arms (Remdesivir, Chloroquine or Hydroxychloroquine, Lopinavir/Ritonavir, or Lopinavir/Ritonavir plus Interferon beta-1a)
In early July 2020, the treatment arms in hospitalized patients that included hydroxychloroquine, chloroquine, or lopinavir/ritonavir were discontinued owing to the drugs showed little or no reduction in mortality compared with standard of care.