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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 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.
Programs established by the FDA allowing clinicians to gain access to investigational therapies during the pandemic have 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. A review by Rizk et al describes the role for each of these measures and their importance of providing medical countermeasures in the event of infectious disease and other threats.
COVID-19 EUAs
The antiviral drug, remdesivir (Veklury) and the mRNA COVID-19 vaccine (Comirnaty) have gained full approval from the FDA. However, certain indications and use in specific populations for each of these therapies remain within their EUAs.
EUA facts sheets for clinicians are available to provide detailed information regarding drugs, biologicals, and vaccines that have been issued an EUA as a COVID-19 therapy or prevention.
Remdesivir
Full FDA approval: Remdesivir is indicated for adults and pediatric patients aged 12 years and older (weighing at least 40 kg) for treatment of COVID-19 that requires hospitalization
EUA: Treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg
Tocilizumab
EUA: Tocilizumab’s EUA is for the treatment of hospitalized adults and pediatric patients (aged 2 years and older) with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib
EUA: The baricitinib EUA is 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).
Remdesivir
Several phase 3 clinical trials have tested remdesivir for treatment of COVID-19 in the United States, South Korea, and China. Positive results were seen with remdesivir after use by the University of Washington in the first case of COVID-19 documented on US soil in January 2020. An adaptive randomized trial of remdesivir coordinated by the National Institute of Health (NCT04280705) was started first against placebo, but additional therapies have been added to the protocol as evidence emerges. The first experience with this study involved passengers of the Diamond Princess cruise ship in quarantine at the University of Nebraska Medical Center in February 2020 after returning to the United States from Japan following an on-board outbreak of COVID-19. Trials of remdesivir for moderate and severe COVID-19 compared with standard of care and varying treatment durations are ongoing.
An EUA for molnupiravir was requested in October 2021. The FDA’s Antimicrobial Drugs Advisory Committee narrowly voted to recommend the FDA authorize molnupiravir for EUA on November 30, 2021.
Molnupiravir (MK-4482 [previously EIDD-2801]; Merck and Ridgeback Biotherapeutics) is an oral antiviral agent that is a prodrug of the nucleoside derivative N4-hydroxycytidine. It elicits antiviral effects by introducing copying errors during viral RNA replication of the SARS-CoV-2 virus.
The phase 3 MOVe-OUT study (n = 1433) found molnupiravir reduced risk of hospitalization or death from 9.7% (68 of 699) in the placebo group to 6.8% (48 of 709) in the molnupiravir group for an absolute risk reduction of 3% (p = 0.02) and a relative risk reduction of 30%. Nine deaths were reported in the placebo group and 1 in the molnupiravir group. These data are consistent with the interim analysis.
Molnupiravir is also being evaluated in a phase 3 trial for postexposure prophylaxis for individuals residing in the same household with someone who tests positive for SARS-CoV-2 in the phase 3 MOVE-AHEAD trial.
An EUA for molnupiravir was requested in October 2021. The FDA’s Antimicrobial Drugs Advisory Committee is scheduled to discuss the request November 30, 2021.
Favipiravir (Avigan, Reeqonus; Appili Therapeutics) is an oral antiviral that disrupts viral replication by selectively inhibiting RNA polymerase. An adaptive, multicenter, open label, randomized, phase 2/3 clinical trial of favipiravir compared with standard of care I hospitalized patients with moderate COVID-19 was conducted in Russia. Both dosing regimens of favipiravir demonstrated similar virologic response. Viral clearance on Day 5 was achieved in 25/40 (62.5%) patients on in the favipiravir group compared with 6/20 (30%) patients in the standard care group (p = 0.018). Viral clearance on Day 10 was achieved in 37/40 (92.5%) patients taking favipiravir compared with 16/20 (80%) in the standard care group (p = 0.155).
The phase 3 PRESECO (PREventing SEvere COVID-19) study evaluated early treatment in patients with mild-to-moderate symptoms to prevent disease progression and hospitalization. Entrollment was completed in September 2021. The phase 3 PEPCO (Post Exposure Prophylaxis for COVID-19) study in asymptomatic individuals with direct exposure (within 72 hours) to an infected individual is ongoing.
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