Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial)
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Abstract
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 ±5.90 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.
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SciScore for 10.1101/2020.07.07.20145979: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was obtained from the participants to admit the study. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:However, this study has some limitations, including its small sample size; single center design, short time for the study, and being nonrandomized. In …
SciScore for 10.1101/2020.07.07.20145979: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was obtained from the participants to admit the study. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:However, this study has some limitations, including its small sample size; single center design, short time for the study, and being nonrandomized. In conclusion, this study showed that adding IVM to HCQ and AZT had a better cure rate and shorter time to stay in the hospital compared with controls. In addition, it was relatively safe without observable safety signals. These findings may suggest using IVM as an add on therapy to protocols used for treatment of COVID-19. However, these results are needed to be validated in a larger prospective follow up study. The results of the study must not be considered conclusive since unknown confounders cannot always be reliably accounted and we recommend further studies. A national multicenter randomized study is planned to perform in different provinces of Iraq using IVM alone since HCQ is temporary withdrawn from the COVID 19 therapy according to the WHO advice.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04343092 Completed Effectiveness of Ivermectin as add-on Therapy in COVID-19 Ma… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.07.07.20145979: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Informed consent was obtained from the participants to admit the study . Randomization Although data from several ongoing randomized controlled trials (RCT) for IVM will soon provide more informative evidence regarding safety and effectiveness IVM for COVID-19. Blinding not detected. Power Analysis The sample size calculated for this pilot trial was 30 patients : 15 in the active arm ( IVM group) and 15 in the controls (SCA) according to pilot study sample size rule of thumb to get medium effect size of 0.3 Sex as a biological variable Participants Inclusion criteria Inclusion criteria were the following: 1 ) men and women with age at least 18 years 2 ) … SciScore for 10.1101/2020.07.07.20145979: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Informed consent was obtained from the participants to admit the study . Randomization Although data from several ongoing randomized controlled trials (RCT) for IVM will soon provide more informative evidence regarding safety and effectiveness IVM for COVID-19. Blinding not detected. Power Analysis The sample size calculated for this pilot trial was 30 patients : 15 in the active arm ( IVM group) and 15 in the controls (SCA) according to pilot study sample size rule of thumb to get medium effect size of 0.3 Sex as a biological variable Participants Inclusion criteria Inclusion criteria were the following: 1 ) men and women with age at least 18 years 2 ) mild to moderate COVID-19 diagnosed by positive polymerase chain reaction ( PCR ) testing <=3 days from enrollment 3)Patient acceptance and willingness to comply with planned study procedures and to complete the follow up . 4 ) hospital admission 5 ) no participation in other clinical trials , such as antiviral trials , during the study period. 6 ) Able to provide informed consent Mild and moderate COVID-19 were defined according to World Health Organization ( WHO ) interim guidance ( 16) Table 2: Resources
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
- However, this study has some limitations, including its small sample size; single center design, short time for the study, and being nonrandomized.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.
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