Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
66 participants
INTERVENTIONAL
2020-05-11
2020-09-02
Brief Summary
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Detailed Description
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Ivermectin 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 \> 80 kg) in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days) + favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) + azithromycin (first day 500mg followed by 4 days 250mg/day, po, total 5 days)- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin.
The mutations in 29 pairs of primers in mdr1/abcab1 gene by sequencing analysis using Sanger method, and the haplotypes and mutations of the CYP3A4 gene that cause the function losing were investigated among the patients who meet criteria and who were included in the study group according to randomization. Mutation screening was done when the first dose of the research drug ivermectin was given, ivermectin treatment was not continued in patients with mutations detected as a result of genetic examination and these patients were excluded from the study.
Patients were followed for 5 additional days after treatment. At the end of the treatment and follow-up period (At the end of 10th day), clinical response and changes in oxygenation and laboratory parameters were evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Patients who were hospitalised with a pre-diagnosis of severe COVID-19 pneumonia and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the "COVID-19 (SARS-CoV-2 Infection) Guide" prepared by the Republic of Turkey Ministry of Health.
No interventions assigned to this group
Study Group
In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in \> 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.
Ivermectin
Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Interventions
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Ivermectin
Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;
1. Presence of tachypnea ≥ 30/minute, SpO2 level \< 90% in room air, PaO2/FiO2 \<300 in oxygen receiving patient
2. Presence of specific radiological finding for COVID-19 in lung tomography (bilateral lobular, peripherally located, diffuse patchy ground glass opacities)
3. Mechanical ventilation requirement
4. Acute organ dysfunction findings; patients with SOFA (sepsis-related organ failure assessment) score \>2
Exclusion Criteria
1. Pediatric patients; \<18 years of old
2. Patients with chronic liver or kidney disease
3. Pregnant women
4. Patients with known ivermectin allergy
18 Years
ALL
Yes
Sponsors
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NeuTec Pharma
INDUSTRY
Afyonkarahisar Health Sciences University
OTHER
Responsible Party
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Nurullah Okumuş
Prof. Dr.
Principal Investigators
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Nurullah Okumuş, Prof. Dr.
Role: STUDY_CHAIR
Afyonkarahisar Health Science University, Afyonkarahisar, Turkey
Neşe Demirtürk, A. Prof. Dr.
Role: STUDY_DIRECTOR
Afyonkarahisar Health Science University, Afyonkarahisar, Turkey
Rıza A. Çetinkaya, Prof. Dr.
Role: STUDY_DIRECTOR
Haydarpasa Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Rahmet Güner, Prof. Dr.
Role: STUDY_DIRECTOR
Yıldırım Beyazıt University, Ankara City Hospital, Ankara, Turkey
İsmail Y. Avcı
Role: STUDY_DIRECTOR
Gulhane Faculty of Medicine, University of Health Sciences, Ankara, Turkey
Locations
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Afyonkarahisar Health Science University
Afyonkarahisar, , Turkey (Türkiye)
Gulhane Faculty of Medicine, University of Health Sciences
Ankara, , Turkey (Türkiye)
Yıldırım Beyazıt University, Ankara City Hospital
Ankara, , Turkey (Türkiye)
Haydarpasa Sultan Abdulhamid Han Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Jean SS, Lee PI, Hsueh PR. Treatment options for COVID-19: The reality and challenges. J Microbiol Immunol Infect. 2020 Jun;53(3):436-443. doi: 10.1016/j.jmii.2020.03.034. Epub 2020 Apr 4.
Croci R, Bottaro E, Chan KW, Watanabe S, Pezzullo M, Mastrangelo E, Nastruzzi C. Liposomal Systems as Nanocarriers for the Antiviral Agent Ivermectin. Int J Biomater. 2016;2016:8043983. doi: 10.1155/2016/8043983. Epub 2016 May 8.
Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12.
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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World Health Organization (WHO) Coronavirus Disease (COVID-19) Dashboard
Other Identifiers
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IVMC_03
Identifier Type: -
Identifier Source: org_study_id
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