ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19. Juliana Cepelowicz Rajter, Michael Sherman, Naaz Fatteh, Fabio Vogel, Jamie Sacks, Jean-Jacques Rajter doi: https://doi.org/10.1101/2020.06.06.20124461 https://www.medrxiv.org/content/10.1101/2020.06.06.20124461v2
Importance: No therapy to date has been shown to improve survival for patients infected with SARS-CoV-2. Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in vitro but clinical response has not been previously evaluated.
Objective: To determine whether Ivermectin is associated with lower mortality rate in patients hospitalized with COVID-19.
Design and Setting: Retrospective cohort study of consecutive patients hospitalized at four Broward Health hospitals in South Florida with confirmed SARS-CoV-2. Enrollment dates were March 15, 2020 through May 11, 2020. Follow up data for all outcomes was May 19, 2020.
Participants: 280 patients with confirmed SARS-CoV-2 infection (mean age 59.6 years [standard deviation 17.9], 45.4% female), of whom 173 were treated with ivermectin and 107 were usual care were reviewed. 27 identified patients were not reviewed due to multiple admissions, lack of confirmed COVID results during hospitalization, age less than 18, pregnancy, or incarceration.
Exposure: Patients were categorized into two treatment groups based on whether they received at least one dose of ivermectin at any time during the hospitalization. Treatment decisions were at the discretion of the treating physicians. Severe pulmonary involvement at study entry was characterized as need for either FiO2 ≥50%, or noninvasive or invasive mechanical ventilation.
Main Outcomes and Measures: The primary outcome was all-cause in-hospital mortality. Secondary outcomes included subgroup mortality in patients with severe pulmonary involvement and extubation rates for patients requiring invasive ventilation. Results: Univariate analysis showed lower mortality in the ivermectin group (25.2% versus 15.0%, OR 0.52, 95% CI 0.29-0.96, P=.03). Mortality was also lower among 75 patients with severe pulmonary disease treated with ivermectin (38.8% vs 80.7%, OR 0.15, CI 0.05-0.47, P=.001), but there was no significant difference in successful extubation rates (36.1% vs 15.4%, OR 3.11 (0.88-11.00), p=.07). After adjustment for between-group differences and mortality risks, the mortality difference remained significant for the entire cohort (OR 0.27, CI 0.09-0.85, p=.03; HR 0.37, CI 0.19-0.71, p=.03).
Conclusions and Relevance: Ivermectin was associated with lower mortality during treatment of COVID-19, especially in patients who required higher inspired oxygen or ventilatory support. These findings should be further evaluated with randomized controlled trials.
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial) Faiq I. Gorial, Sabeeh Mashhadani, Hend M Sayaly, Basim Dhawi Dakhil, Marwan M AlMashhadani, Adnan M Aljabory, , Hassan M Abbas, Mohammed Ghanim, Jawad I Rasheed doi: https://doi.org/10.1101/2020.07.07.20145979
Background: To date no effective therapy has been demonstrated for COVID-19. In vitro, studies indicated that ivermectin (IVM) has antiviral effect. Objectives: To assess the effectiveness of ivermectin (IVM) as add-on therapy to hydroxychloroquine (HCQ) and azithromycin (AZT) in treatment of COVID-19. Methods: This Pilot clinical trial conducted on hospitalized adult patients with mild to moderate COVID-19 diagnosed according to WHO interim guidance. Sixteen Patients received a single dose of IVM 200Mcg /kg on admission day as add on therapy to hydroxychloroquine ( HCQ)and Azithromycin (AZT) and were compared with 71 controls received HCQ and AZT matched in age, gender, clinical features, and comorbidities. The primary outcome was percentage of cured patients, defined as symptoms free to be discharged from the hospital and 2 consecutive negative PCR test from nasopharyngeal swabs at least 24 hours apart. The secondary outcomes were time to cure in both groups and evaluated by measuring time from admission of the patient to the hospital till discharge. Results: Of 87 patients included in the study,t he mean age ± SD (range) of patients in the IVM group was similar to controls [44.87 ± 10.64 (28-60) vs 45.23 ± 18.47 (8-80) years, p=0.78] Majority of patients in both groups were male but statistically not significant [11(69%) versus 52 (73%), with male: female ratio 2.21 versus 2.7-, p=0.72) All the patients of IVM group were cured compared with the controls [ 16 (100 %) vs 69 (97.2 %)]. Two patients died in the controls. The mean time to stay in the hospital was significantly lower in IVM group compared with the controls (7.62 ±2.75 versus 13.22 ±.90 days, p=0.00005, effect size= 0.82). No adverse events were observed Conclusions : Add-on use of IVM to HCQ and AZT had better effectiveness, shorter hospital stay, and relatively safe compared with controls. however, a larger prospective study with longer follow up may be needed to validate these results.
A comparative observational study on Ivermectin- Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients. Taiub, Abu & Mohiuddin Chowdhury, Abu Taiub Mohammed & Shahbaz, Mohammad & Karim, Md & Islam, Jahirul & Dan, Guo & Shuixiang, He. (2020). https://clinicaltrials.gov/ct2/show/NCT04434144
For the study purpose, the patients were divided into two groups, as follows:
Group A (n=60): Ivermectin 200μgm/kg single dose + Doxycycline 100mg BID for 10days
Group B (n=56): Hydroxychloroquine 400mg 1 st day then200mg BID for 9days + Azithromycin 500mg daily for 5Days.
Results: All subjects in the Ivermectin-Doxycycline group (group A) reached a negative PCR for SARS-CoV-2, at a mean of 8.93days, and all reached symptomatic recovery, at a mean of 5.93days, with 55.10% symptom-free by the 5 th day. In the Hydroxychloroquine-Azithromcyin group (group B), 96.36% reached a negative PCR at a mean of 6.99days and were symptoms-
free at 9.33days. Group A patients had symptoms that could have been caused by the medication in 31.67% of patients, including lethargy in 14(23.3%), nausea in 11(18.3%), and occasional vertigo in 7(11.66%) of patients. In Group B, 46.43% had symptoms that could have been caused
by the medication, including 13(23.21%) mild blurring of vision and headache; 22(39.2%) increased lethargy and dizziness, 10(17.85%) occasional palpitation, and 9(16.07%) nausea and vomiting.
Conclusion: The Ivermectin-Doxycycline combination showed a trend toward superiority to the Hydroxychloroquine-Azithromycin combination therapy in the case of patients with mild to moderate COVID19 disease, though the difference in time to becoming symptom-free and the difference in time to negative PCR was not statistically significant.
Clinical Trials: Studies found for ivermectin | covid-19
A Review of SARS-CoV-2 and the Ongoing Clinical Trials. Tu, Y.-F. et al. Int. J. Mol. Sci. 2020, 21, 2657. https://www.mdpi.com/1422-0067/21/7/2657/htm