Question

In late February, the US National Institutes of Health (NIH) announced that a new study to evaluate the safety and efficacy of the antiviral drug remdesivir in hospitalized adults diagnosed with COVID-19 had begun at the University of Nebraska Medical Center (UNMC) in Omaha.  

Participants in the NIH-sponsored study must be hospitalized for lab-confirmed COVID-19, provide informed consent to participate in the study, and undergo a baseline physical exam before receiving treatment. They will then be randomly assigned either to the remdesivir treatment group or the placebo group. Participants in the treatment group will receive 200 milligrams (mg) of remdesivir intravenously on the first day of enrollment followed by 100 mg each day for the duration of hospitalization, for up to 10 days total. The placebo group will receive, at an equal volume, a solution that resembles remdesivir but contains only inactive ingredients. Investigators and participants will not know who is receiving remdesivir or placebo.

Initially, investigators plan to compare participant outcomes on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo. Outcomes will be scored on a seven-point scale ranging from fully recovered to death.

1.This study is                            [ Select ]                      

• ["a case-control observational study", "a longitudinal cohort study", "a census (population data)", "a cross-sectional sample survey", "a matched pairs/repeated measures experiment", "an unscientific study using voluntary response or anecdotal data", "a completely randomized experiment"]      
  2. To avoid potential bias, the study is designed to                            [ Select ]                      
• ["have a double-dummy", "be mandatory", "be double-blinded", "minimize nonresponse", "be voluntary", "minimize response bias"]      
  3. The response variable is                            [ Select ]                      
• ["day-15 outcome score", "score difference (remdesivir minus placebo)", "death rate", "survival", "recovery rate"]      

Answer 1

1.

This study is  a completely randomized experiment as the participants are randomly assigned to one of two treatment conditions.

2.

To avoid potential bias, the study is designed to be double-blinded as both investigators and participants will not know who is receiving remdesivir or placebo.

3.

Investigators plan to compare participant outcomes on day 15 in both the remdesivir group and the placebo group

The response variable is score difference (remdesivir minus placebo)