Yet another clinical trial result points out the possible benefits of ivermectin in relations to COVID-19 treatments. This time, a study led by researchers from Afyonkarahisar Health Sciences University, as well as other academic medical centers in Turkey, used a combination of treatments to determine if ivermectin would have an impact. Both the study group and the control group received a combination of hydroxychloroquine, favipiravir, and azithromycin. TrialSite notes that these drugs are commonly used in Turkey against the coronavirus. So this small study added Ivermectin to determine greater efficacy. The study results were recently published in the peer review journal BMC Infectious Diseases. This randomized, controlled, single-blind Phase 3 study focused on patients infected with severe COVID-19 pneumonia. The study team found that ivermectin can boost clinical recovery improvement in prognostic laboratory parameters while decreasing mortality rates even in severe cases. The investigators led by corresponding author Nurullah Okumus suggest that ivermectin should be considered as a therapy for COVID-19 treatment regimens or as an additional consideration for existing protocols.
Turkey has experienced three waves of infections during the pandemic. A first wave occurred in April and only lasted a month. Thereafter, the country experienced considerable stability until November when a much bigger wave occurred as cases spiked up over 33,000 per day by early December. By late January, cases had plummeted to about 6,081 seven day daily averages. Based on a few factors, including mutant variants, a much bigger wave hit the country again by April 20 with over 60,000 new cases per day. By then,Turkey had accepted the use of favipiravir and hydroxychloroquine.
Note that the number of infections, as measured by estimated average daily new infection count, again has dropped precipitously now at 29,224 per day based on a running seven day average by May 5.
14.2 million people in this country of 82 million people have received at least one vaccine dose representing 17.4% of the country while 9.8 million (12%) have received full two doses, according to Our World Data.
The Reference Treatment
Turkey has adopted the generic antiviral favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) as well as the controversial anti-malarial drug hydroxychloroquine (2x400mg loading dose followed by 2x200mg po, 5 days). This reference treatment also includes the antibiotic azithromycin ((500 mg first day loading dose, followed by 250 mg/day, po, total 5 days ). Known as “HFA” in the study this regimen was administered to all of the patients.
Sponsored by Afyonkarahisar Health Sciences University in partnership with NuTec Pharma, this Phase 3 clinical trial (NCT04646109) started back in September 2020. While most ivermectin studies have emphasized early onset, mild-to-moderate SARS-CoV-2 infections, this particular study interestingly included patients with severe COVID-19 pneumonia.
With two groups (study drug and placebo), the study group patients received 200 mcg/kg/day for five days (9 mg between 36-50 kg, 12 mg between 51-65 kg, 15 mg between 66-79 kg and 200 microgram/kg in those > 80 kg) in the form of a solution prepared for external use added to the reference treatment protocol. Apparently, for this study, the reference protocol involved the use of hydroxychloroquine, favipiravir and azithromycin. TrialSite notes that both hydroxychloroquine and favipiravir are frequently used in Turkey against the coronavirus.
Of the 66 patients, 36 were assigned to the study group and 30 to the control group. The authors reported that mutations affecting ivermectin metabolism were identified in genetic tests in six (16.7%) of the patients in the study group and consequently they were excluded.
During the five day follow-up period, the investigators and team observed a clinical improvement rate of 73.3% (22/30) in the study group and 53.3% (16.30) in the control group (p =0.10).
The group of patients were in severe shape and consequently in the study group 6 (20%) died while in the control group the study lost 9 (30%) patients (p = 0.37). Further, the study team observed that average peripheral capillary oxygen saturation (SpO2) values were 93.5 and 93.0% respectively. They reported that partial pressure of oxygen (PaO2)/FiO2 ratios equaled 236.3± 85.7 and 220.8 ± 127.3 in the study and control group respectively.
Interestingly, the blood lymphocyte count turned up higher in the study group as compared to the control group (1698 ± 1438 and 1256 ± 710, respectively) at then of the follow up period (p = 0.24 ) but reduction in serum C-reactive protein (CRP), ferritin, and D-dimer levels were greater in the study group. (p = 0.02, p = 0.005 and p = 0.03, respectively).
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Participating Research Sites
A handful of Tukish academic medical centers conducted this clinical trial led by Afyonkarahisar Health Sciences University (AHSU) is a health-themed university with four faculties, three vocational schools, and a postgraduate education institute in which future physicians, dentists, specialist physicians, specialist dentists and other health professionals are trained.
Other centers include Gulhane Faculty of Medicine, University Health Sciences in Ankara, Yildirim Beyazit University’s Ankara City Hospital and Haydarpasa Sultan Abdulhamid Han Training and Research Hospital in Istanbul.
A leading Turkish pharmaceutical company, NuTec is based in Istanbul with 4 dedicated manufacturing facilities in Adapazari/Sakarva. The company produces drugs and markets and distributes such formulations as branded generics domestically as well as to the Middle East, Asia and Eastern Europe as well as other markets. The company is purported to be one of the fastest growing companies in the region.
Dr. Nurullah Okumus, Professor, Afyonkarahisar Health Sciences University, Afyonkarahisar Health Science University, Study Chair & Corresponding Author
Call to Action: TrialSite reminds that the particular therapy available depends on the jurisdiction an individual resides in. The treatments in Turkey such as hydroxychloroquine are not accepted by U.S. and European regulatory bodies, for example.