BACKGROUND AND PURPOSE: 

• Remdesivir has been shown to improve outcomes in hospitalized patients with moderate-to-severe COVID-19  
• Gottlieb et al. (NEJM, 2021) evaluated the efficacy and safety of a 3-day course of remdesivir in high-risk, non-hospitalized patients with Covid-19 

METHODS: 

• Randomized, double-blind, placebo-controlled trial 
  • PINETREE Clinical Trial  
• Participants 
  • Non-hospitalized COVID-19 patients  
  • Symptom onset within the previous 7 days  
  • ≥1 risk factor for disease progression  
    • Age ≥60 years | Obesity | Coexisting medical conditions 
• Interventions 
  • Intravenous remdesivir for 3 days 
    • 200 mg on day 1 and 100 mg on days 2 and 3 
  • Placebo 
• Primary outcome 
  • A composite of COVID-19–related hospitalization or death from any cause by day 28 
• Primary safety outcome 
  • Any adverse event 
• Secondary outcome 
  • A composite of a COVID-19–related medically attended visit or death from any cause by day 28 

RESULTS: 

• Remdesivir group: 279 patients | Placebo group: 283 patients 
  • Mean age: 50 years 
  • 47.9% women 
  • 41.8% Hispanic or Latino/a 
• Common coexisting conditions 
  • Diabetes mellitus: 61.6% 
  • Obesity: 55.2% 
  • Hypertension: 47.7% 
• Covid-19–related hospitalization or death from any cause was less frequent in the remdesivir group 
  • Remdesivir: 0.7% (2 patients) 
  • Placebo: 5.3% (15 patients) 
  • Hazard ratio (HR) 0.13 (95% CI, 0.03 to 0.59); P=0.008 
• Patients in the remdesivir group were less likely to need medical treatment by day 28 
  • Remdesivir: 1.6% 
  • Placebo: 8.3% 
  • HR 0.19 (95% CI, 0.07 to 0.56) 
• No patients had died by day 28 

Adverse Events 

• Overall 
  • Remdesivir: 42.3%  
  • Placebo: 46.3%  
• Most common in ≥5% in both groups  
  • Nausea | Headache | Cough 
• Adverse events related to the trial regimen  
  • Remdesivir: 12.2% 
  • Placebo group: 8.8% 
• Overall, fewer patients in the remdesivir group had serious adverse events 
  • Remdesivir: 1.8% 
  • Placebo: 6.7%  

CONCLUSION: 

• Non-hospitalized patients with COVID-19 and risk factors for disease progression who received a 3-day course of remdesivir were 87% less likely to require hospitalization or die compared to patients who received placebo 
• Remdesivir had an acceptable safety profile in this population with incidence of adverse events similar to placebo  
• The authors state 

In the campaign toward ending the Covid-19 pandemic, these data add yet another option to the armamentarium for the treatment of vulnerable patients who are at high risk for progression to severe Covid-19 

Learn More – Primary Sources: 

Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients 

Related ObG Topics:

RCT Results: Does Remdesivir Improve Clinical Status in Patients with Moderate COVID-19?

The Final Report from ACTT-1 RCT: Remdesivir Decreases Time to Recovery

Remdesivir RCT Results: 5 or 10 Day Treatment for Severe COVID-19?