— Malaysian trial finds no difference in progression to severe disease over standard of care

by Molly Walker

A photo of a box of Ivermectin Dispersible tablets

Ivermectin failed to prevent older adults with COVID-19 from progressing to severe disease compared with standard of care alone, an open-label randomized trial in Malaysia found.

Among 490 patients, 21.6% of those given ivermectin plus standard of care progressed to severe disease versus 17.3% of those who received standard of care alone (relative risk [RR] 1.25, 95% CI 0.87-1.80, P=0.25), reported Steven Chee Loon Lim, MRCP, of Raja Permaisuri Bainun Hospital in Malaysia, and colleagues in JAMA Internal Medicine.

There were also no significant differences between groups in terms of onset of deterioration (3.2 days in the intervention group vs 2.9 in controls), or any other secondary outcomes, including:

  • Mechanical ventilation (RR 0.41, 95% CI 0.13-1.30, P=0.17)
  • ICU admission (RR 0.78, 95% CI 0.27-2.20, P=0.79)
  • In-hospital mortality at day 28 (RR 0.31, 95% CI 0.09-1.11, P=0.09)

Results were similar in subgroup analyses among patients with severe disease.

Lim’s group noted that while prior trials found no benefit with ivermectin for COVID, it is still “widely prescribed,” despite guidance from the World Health Organization to restrict use of the drug to clinical trials.

“Evidence-based data to recommend either for or against the use of ivermectin are needed,” they wrote.

The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was conducted at 20 government hospitals and a COVID quarantine center in Malaysia from May 31 to October 25, 2021. Adults ages 50 and up who tested positive for SARS-CoV-2 via RT-PCR were included. Participants had at least one comorbidity and presented with mild to moderate illness within 7 days of symptom onset.

Patients were managed according to Malaysian guidelines, including “symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging,” the authors noted.

Overall, the modified intention-to-treat population included 490 patients: 241 randomized to receive oral ivermectin 0.4 mg/kg of body weight daily for 5 days plus standard of care and 249 randomized to standard of care alone. Among all of the patients, mean age was about 63, 55% were women, and 52% were fully vaccinated with a two-dose primary series. Three-quarters had hypertension, over half had diabetes (54%), and over a third had dyslipidemia (38%).

Mean duration of symptoms at enrollment was 5 days, and two-thirds of patients had “moderate” disease.

A total of 55 adverse events (AEs) occurred, with 33 in the ivermectin group. Diarrhea was the most common AE (6%). Four out of five serious AEs were in the ivermectin group. Six patients discontinued ivermectin and three withdrew from the study due to AEs.

There were 13 deaths, nine of which were attributed to COVID pneumonia (69%); none were attributed to ivermectin.

Study limitations included its open-label design, the fact that the study was not powered to assess the effect of ivermectin on COVID mortality, and that the findings may not be generalizable to all populations, as the study participants were older adults.

However, the authors were unequivocal in their conclusions: “The study findings do not support the use of ivermectin for patients with COVID-19,” they wrote.

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