SUMMARY:

The ‘Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial’ is a national program in the UK to study multiple potential therapies for SARS-CoV-2 infection. The program involves thousands of doctors, nurses, pharmacists, and research personnel. The dexamethasone branch of the RECOVERY Trial program was halted on June 8th because the steering committee felt there was sufficient evidence to make a determination whether there was benefit to this therapy. The chief investigators, Professors Horby and Landray, reported the findings on June 16, 2020.

• The preliminary results found that

Overall dexamethasone reduced the 28-day mortality rate by 17% (0.83 [0.74 to 0.92]; P=0.0007) with a highly significant trend showing greatest benefit among those patients requiring ventilation (test for trend p<0.001)

Methods

Randomized controlled trial (RCT)

• Participants
  • Patients hospitalized with COVID-19
• Randomization
  • Dexamethasone 6 mg daily (oral or IV) vs usual care alone
• Primary Outcomes
  • Within 28 days after randomization: Death | Discharge | Need for ventilation | Need for renal replacement therapy
• Additional data collected
  • Age | Sex | Major co-morbidity | Pregnancy | COVID-19 onset date and severity

Results

• Dexamethasone group: 2104 patients | Usual care alone: 4321 patients
• Usual care group
  • 28-day mortality rates
    • Requiring ventilation: 41%
    • Oxygen only: 25%
    • No respiratory intervention: 13%
• Dexamethasone group: Reduction in deaths vs usual care alone
  • Requiring ventilation: Rate ratio (RR) 0.65 (95% CI, 0.48 to 0.88]; p=0.0003)
  • Oxygen only: RR 0.80 (95% CI, 0.67 to 0.96; p=0.0021)
  • No respiratory intervention: RR 1.22 (95% CI, 0.86 to 1.75; p=0.14)
• Need to treat
  • Ventilated patients: 1 death would be prevented by treatment of approximately 8 patients
  • Oxygen alone: 1 death prevented by treatment of approximately 25 patients

KEY POINTS:

• Reduction in deaths for hospitalized patients with COVID-19 with the use of low dose dexamethasone
  • Reduced deaths by one-third in ventilated patients
  • Reduced deaths by 20% for oxygen only patients   
  • No benefit for patients not requiring respiratory support
• Full report will be published
• Professor Hornsby, one of the chief investigators states that

…dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide

Learn More – Primary Sources:

RECOVERY TRIAL: Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report (NEJM)

Related ObG Topics:

Chief Investigators of the RECOVERY Trial Report on the Hydroxychloroquine RCT

NIH COVID-19 Treatment Guidelines

Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data