Led by Karamat Hu Bukhari, FCPS, MED at the Combined Military Hospital Lahore, in Pakistan, yet another randomized controlled trial evidences a statistically significant benefit of the use of ivermectin in association with the standard of care for individuals with mild to moderate COVID-19. Once randomized, participants, totaling 86 were segmented into two groups, including the standard of care in this country (Chloroquine) in one and ivermectin plus the standard of care in the other. The primary endpoint was days to negative based on a PCR test. Ivermectin demonstrated a notable level of efficacy without any adverse side effects. With only 86 participants, the statistical power of the study could represent a limitation. The study wasn’t blinded.
TrialSite introduced this study back on May 29, 2020.
This clinical trial (NCT04392713), sponsored by the Combined Military Hospital in Pakistan sought to evaluate the efficacy of ivermectin as an addition to the standard of care (SOC) in the country of Pakistan to treat COVID19-patients with mild to moderate disease. The study was conducted at the Combined Military Hospital Lahore from March 15, 2020, to June 15, 2020. Initially targeting 100 participants, the study recruited 86 patients who tested positive for COVID-19 via RT-PCR.
Patients were stratified via lottery approach into two groups including A) administered the standard of care (SOC) treatment as per the existing hospital guidelines and B) ivermectin group (single dose of 12 milligrams (along with SOC treatment).
The study team conducted PCR testing at 72 hours, 7th day, and 14th day of admission for both study groups, and the study team recorded the point in time that the PCR became negative. The study team conducted other assays from blood count to the liver and renal tests on day 7 and day 15.
The primary endpoint of the study, viral clearance as measured in days to achieve PCR negatively was followed by secondary endpoints of A) reporting of any adverse side effects and B) imbalance in baseline laboratory parameters.
Group A had 45 participants (80% male and 20% female) while Group B had 41 participants (90.2% male and 9.8% female). Group A’s mean age was 39, while Group B was 42.2. The study team found that early viral clearance was greater in Group B (ivermectin group) as compared to Group A (the SOC group) at (p=0.001).
As far as primary endpoint at p=0.001:
|Group||72 hour||Day 7||Day 14|
|Group A (SOC)||2||18||25|
|Group B (SO+ IVM)||17||20||5|
Although the power of this study can be questioned (size), the numbers are interesting. The ivermectin group shows a clear benefit. Within 3 days, 17 of the participants are cleared of the virus while only 2 are in the SOC group. By day 7 the numbers are comparable; however, notice day 14 where still 25 individuals have not cleared the SARS-CoV-2 virus while that number falls to 5 in the ivermectin group B.
The team observed no side effects. Based on these findings, the team in Pakistan suggests that ivermectin should be considered as an addition to the standard of care.
Combined Military Hospital Lahore
Based in Punjab, Pakistan, Combined Military Hospital Lahore is the largest Tertiary Care teaching hospital operated by the Pakistan army. It serves to provide specialized medical treatment to the armed forces there, as well as dependents and families and the general public.
With 1,050 beds, the hospital goes back to 1854 when it was the British Military Hospital, established by the British military as a specialized treatment center for British officers serving in the Indian subcontinent.
Karamat Hu Bukhari, FCPS, MED
Asma Asghar, FCPS, MED
Najma Parveen, FCPS, MED