Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial
Abstract Background The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectivenes...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06649-3 |
| _version_ | 1811285898235478016 |
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| author | Anan Manomaipiboon Kittisak Pholtawornkulchai Sujaree Poopipatpab Swangjit Suraamornkul Jakravoot Maneerit Wiroj Ruksakul Uraporn Phumisantiphong Thananda Trakarnvanich |
| author_facet | Anan Manomaipiboon Kittisak Pholtawornkulchai Sujaree Poopipatpab Swangjit Suraamornkul Jakravoot Maneerit Wiroj Ruksakul Uraporn Phumisantiphong Thananda Trakarnvanich |
| author_sort | Anan Manomaipiboon |
| collection | DOAJ |
| description | Abstract Background The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectiveness against various agents, including SARS-CoV-2. This study aimed to assess the efficacy of ivermectin treatment compared with the standard of care (SOC) among people with mild to moderate COVID-19 symptoms. Methods In this randomized, double-blind, placebo-controlled, single-center, parallel-arm, superiority trial among adult hospitalized patients with mild to moderate COVID-19, 72 patients (mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (n=36) or placebo (n=36) group, along with receiving standard care. We aimed to compare the negativity of reverse transcription polymerase chain reaction (RT-PCR) result at days 7 and 14 of enrolment as the primary outcome. The secondary outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and adverse events. Results At days 7 and 14, no differences were observed in the proportion of PCR-positive patients (RR 0.97 at day 7 (p=0.759) and 0.95 at day 14 (p=0.813). No significant differences were found between the groups for any of the secondary endpoints, and no adverse events were reported. Conclusion No difference was found in the proportion of PCR-positive cases after treatment with ivermectin compared with standard care among patients with mild to moderate COVID-19 symptoms. However, early symptomatic recovery was observed without side effects. Trial registration ClinicalTrials.gov NCT05076253. Registered on 8 October 2021, prospectively. |
| first_indexed | 2024-04-13T02:50:52Z |
| format | Article |
| id | doaj.art-d2e56f40d4774915872a819d28c4cc5f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T02:50:52Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d2e56f40d4774915872a819d28c4cc5f2022-12-22T03:05:51ZengBMCTrials1745-62152022-08-0123111010.1186/s13063-022-06649-3Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trialAnan Manomaipiboon0Kittisak Pholtawornkulchai1Sujaree Poopipatpab2Swangjit Suraamornkul3Jakravoot Maneerit4Wiroj Ruksakul5Uraporn Phumisantiphong6Thananda Trakarnvanich7Faculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityFaculty of Medicine, Vajira Hospital, Navamindradhiraj UniversityAbstract Background The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pandemic. Ivermectin is an antiparasitic drug that has shown effectiveness against various agents, including SARS-CoV-2. This study aimed to assess the efficacy of ivermectin treatment compared with the standard of care (SOC) among people with mild to moderate COVID-19 symptoms. Methods In this randomized, double-blind, placebo-controlled, single-center, parallel-arm, superiority trial among adult hospitalized patients with mild to moderate COVID-19, 72 patients (mean age 48.57 ± 14.80 years) were randomly assigned to either the ivermectin (n=36) or placebo (n=36) group, along with receiving standard care. We aimed to compare the negativity of reverse transcription polymerase chain reaction (RT-PCR) result at days 7 and 14 of enrolment as the primary outcome. The secondary outcomes were duration of hospitalization, frequency of clinical worsening, survival on day 28, and adverse events. Results At days 7 and 14, no differences were observed in the proportion of PCR-positive patients (RR 0.97 at day 7 (p=0.759) and 0.95 at day 14 (p=0.813). No significant differences were found between the groups for any of the secondary endpoints, and no adverse events were reported. Conclusion No difference was found in the proportion of PCR-positive cases after treatment with ivermectin compared with standard care among patients with mild to moderate COVID-19 symptoms. However, early symptomatic recovery was observed without side effects. Trial registration ClinicalTrials.gov NCT05076253. Registered on 8 October 2021, prospectively.https://doi.org/10.1186/s13063-022-06649-3EfficacyIvermectinCOVID-19Randomized controlled trialSARS-CoV-2RT-PCR |
| spellingShingle | Anan Manomaipiboon Kittisak Pholtawornkulchai Sujaree Poopipatpab Swangjit Suraamornkul Jakravoot Maneerit Wiroj Ruksakul Uraporn Phumisantiphong Thananda Trakarnvanich Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial Trials Efficacy Ivermectin COVID-19 Randomized controlled trial SARS-CoV-2 RT-PCR |
| title | Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of ivermectin in the treatment of mild to moderate covid 19 infection a randomized double blind placebo controlled trial |
| topic | Efficacy Ivermectin COVID-19 Randomized controlled trial SARS-CoV-2 RT-PCR |
| url | https://doi.org/10.1186/s13063-022-06649-3 |
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