ABSTRACT
Background: Ivermectin which was widely considered as a potential treatment for COVID-19, showed uncertain clinical benefit in many clinical trials. Performing large-scale clinical trials to evaluate the effectiveness of this drug in the midst of the pandemic, while difficult, has been urgently needed. Methods: We performed two large multicenter randomized, double-blind, placebo-controlled clinical trials evaluating the effectiveness of ivermectin in treating inpatients and outpatients with COVID-19 infection. The intervention group received ivermectin, 0.4mg/kg of body weight per day for 3 days. In the control group, placebo tablets were used for 3 days. Results: Data for 609 inpatients and 549 outpatients were analyzed. In hospitalized patients, complete recovery was significantly higher in the ivermectin group (37%) compared to placebo group (28%; RR, 1.32 [95% CI, 1.04-1.66]; p-value = 0.02). On the other hand, the length of hospital stay was significantly longer in the ivermectin group with a mean of 7.98 ± 4.4 days compared to the placebo receiving group with a mean of 7.16 ± 3.2 days (RR, 0.80 [95% CI, 0.15-1.45]; p-value = 0.02). In outpatients, the mean duration of fever was significantly shorter (2.02 ± 0.11 days) in the ivermectin group versus (2.41 ± 0.13 days) placebo group with p value = 0.020. On the day seventh of treatment, fever (p-value = 0.040), cough (p-value = 0.019), and weakness (p-value = 0.002) were significantly higher in the placebo group compared to the ivermectin group. Among all outpatients, 7% in ivermectin group and 5% in placebo group needed to be hospitalized (RR, 1.36 [95% CI, 0.65-2.84]; p-value = 0.41). Also, the result of RT-PCR on day five after treatment was negative for 26% of patients in the ivermectin group versus 32% in the placebo group (RR, 0.81 [95% CI, 0.60-1.09]; p-value = 0.16). Conclusion: Our data showed, ivermectin, compared with placebo, did not have a significant potential effect on clinical improvement, reduced admission in ICU, need for invasive ventilation, and death in hospitalized patients; likewise, no evidence was found to support the prescription of ivermectin on recovery, reduced hospitalization and increased negative RT-PCR assay for SARS-CoV-2 5 days after treatment in outpatients. Our findings do not support the use of ivermectin to treat mild to severe forms of COVID-19. Clinical Trial Registration: www.irct.ir IRCT20111224008507N5 and IRCT20111224008507N4.
ABSTRACT
Kikuchi-Fujimoto Disease (KFD), is a rare and self-limited condition of histiocytic necrotizing lymphadenitis, which typically presents as fever and lymphadenopathy. We describe a case of KFD in an Iranian woman. Due to low incidence and high importance, awareness of this disease is necessary for clinicians for early diagnosis and appropriate treatment. A 26-year-old woman was admitted to our hospital with a 3-week history of fever and lymphadenopathy. On physical examination, she had three separate enlarged lymph nodes on the right side of her neck. In laboratory tests that were carried out, she had mild anemia and an increase in C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR) and lactate dehydrogenase (LDH) level, while other tests were normal. Ultasound (U/S) guided core needle lymph node biopsy was performed and based on the histological finding, diagnosis of Kikuchi-Fujimoto disease was made. The patient was managed supportively and with prednisolone. She symptomatically improved and was discharged with no follow up. Although the incidence of KFD is rare, it must be considered as a differential diagnosis of lymphadenopathy especially in tuberculosis-endemic areas like our country-Iran. Moreover, it is necessary that physicians are aware of this disease in order to minimize unnecessary evaluation and toxic treatment.
