Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic

Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus 2

“…The most common laboratory features reported in patients with COVID- 19 and increased bilirubin and creatinine levels (57)(58)(59). Such findings are not surprising, because these biomarkers represent an inflammatory host response to SARS-CoV-2 or are early markers of end-organ dysfunction, similar to that seen in patients with sepsis (60).…”

“…This number is modulated by such factors as the duration of viral shedding, the infectiousness of the organism, and the contact matrix between infected and susceptible persons (18). Given the lack of effective vaccines or treatments (19), the only currently available lever to reduce SARS-CoV-2 transmission is to identify and isolate persons who are contagious.…”

Sample sizes in COVID-19–related research

“…Cheung and colleagues warned that underpowered studies that committed a type II error will discourage clinicians from using effective treatment. 1 I agreed with this argument. Because the number of published clinical trials on coronavirus disease 2019 (COVID-19) patients has been increasing rapidly, I have reviewed all these trials published between Jan. 1, 2020, and Mar.…”

Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives

“…This kind of accelerated procedure will place an extensive load on controlling agencies that only the pandemic itself can rationalize. To solve this, WHO launched the harmonized "Solidarity Trial" in different countries to rapidly assess in thousands of COVID-19 patients to evaluate the effectiveness of current antiviral and antiinflammatory agents not yet evaluated specifically for COVID-19 (Cheng et al, 2020). Similarly, The US National Institute of Allergy and Infectious Diseases (NIAID) commenced an adaptive design for international phase 3 trial called "ACTT" to include up to 800 hospitalized COVID-19 persons at 100 places in numerous countries (Clinicaltrials.Gov, 2020b).…”