TOGETHER (ivermectin)
Trial question
What is the role of early treatment with ivermectin in patients with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 1358
1358 patients (791 female, 567 male).
Inclusion criteria: adult patients who had symptoms of COVID-19 for up to 7 days with one risk factor for disease progression.
Key exclusion criteria: diagnostic test for negative COVID-19 associated with acute flu symptoms; requirement of hospitalization due to COVID-19; acute respiratory symptoms due to other causes; dyspnea secondary to other acute and chronic respiratory causes or infections.
Interventions
N=679 ivermectin (400 mcg/kg of body weight once daily for 3 days).
N=679 placebo (matching placebo for 3 days).
Primary outcome
Hospitalization due to COVID-19 or emergency department visits due to clinical worsening of COVID-19 at 28 days
14.7%
16.3%
16.3 %
12.2 %
8.2 %
4.1 %
0.0 %
Ivermectin
Placebo
No significant
difference ↔
No significant difference in hospitalization due to COVID-19 or emergency department visits due to clinical worsening of COVID-19 at 28 days (14.7% vs. 16.3%; RR 0.9, 95% CI 0.7 to 1.16).
Secondary outcomes
No significant difference in viral clearance at day 7 (25.4% vs. 25.5%; RR 1, 95% CI 0.68 to 1.46).
No significant difference in hospitalization for any cause (11.6% vs. 14%; RR 0.83, 95% CI 0.63 to 1.1).
No significant difference in death (3.1% vs. 3.5%; RR 0.88, 95% CI 0.49 to 1.55).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients who had symptoms of COVID-19 for up to 7 days with one risk factor for disease progression, ivermectin was not superior to placebo with respect to hospitalization due to COVID-19 or emergency department visits due to clinical worsening of COVID-19 at 28 days.
Reference
Gilmar Reis, Eduardo A S M Silva, Daniela C M Silva et al. Effect of Early Treatment with Ivermectin among Patients with Covid-19. N Engl J Med. 2022 May 5;386(18):1721-1731.
Open reference URL