Ivermectin shows clinical benefits in mild to moderate COVID19: a randomized controlled double-blind, dose-response study in Lagos
This article has been Reviewed by the following groups
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
- Evaluated articles (ScreenIT)
Abstract
Introduction
In vitro studies have shown the efficacy of Ivermectin (IV) to inhibit the SARS—CoV-2 viral replication, but questions remained as to in-vivo applications. We set out to explore the efficacy and safety of Ivermectin in persons infected with COVID19.
Methods
We conducted a translational proof of concept randomized, double blind placebo controlled, dose response and parallel group study of IV efficacy in RT—polymerase chain reaction proven COVID 19 positive patients. Sixty-two patients were randomized to three treatment groups. (A) IV 6 mg regime, (B) IV 12 mg regime (given Q84 h for 2 weeks) (C, control) Lopinavir/Ritonavir. All groups plus standard of Care.
Results
The Days to COVID negativity (DTN) was significantly and dose dependently reduced by IV (P = 0.0066). The DTN for Control were, = 9.1+/–5.2, for A 6.0 +/– 2.9 and for B 4.6 +/–3.2. Two way repeated measures ANOVA of ranked COVID 19 +/– scores at 0, 84, 168 and252h showed a significant IV treatment effect (P = 0.035) and time effect (P < 0.0001). IV also tended to increase SPO2% compared to controls, P = 0.073, 95% CI—0.39 to 2.59 and increased platelet count compared to C (P = 0.037) 95%CI 5.55—162.55 × 103/ml. The platelet count increase was inversely correlated to DTN (r = –0.52, P = 0.005). No SAE was reported.
Conclusions
12mg IV regime given twice a week may have superior efficacy over 6mg IV given twice a week, and certainly over the non IV arm of the study. IV should be considered for use in clinical management of SARS-COV2, and may find applications in prophylaxis in high risk areas.
Article activity feed
-
SciScore for 10.1101/2021.01.05.21249131: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol received ethical review and approval of the Institutional Review Board of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria.
Consent: The patient inclusion criteria were COVID 19 PCR proven positive patients, who gave informed, written consent to participate in the study, and were either asymptomatic or had mild/moderate symptoms.Randomization The study was a proof of concept (PoC), double blind, randomized controlled trial, of a parallel group, dose-response design. Blinding The study was a proof of concept (PoC), double blind, randomized controlled trial, of a parallel group, dose-response design. Power Analysis not detected. Sex … SciScore for 10.1101/2021.01.05.21249131: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study protocol received ethical review and approval of the Institutional Review Board of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria.
Consent: The patient inclusion criteria were COVID 19 PCR proven positive patients, who gave informed, written consent to participate in the study, and were either asymptomatic or had mild/moderate symptoms.Randomization The study was a proof of concept (PoC), double blind, randomized controlled trial, of a parallel group, dose-response design. Blinding The study was a proof of concept (PoC), double blind, randomized controlled trial, of a parallel group, dose-response design. 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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title ISRCTN40302986 NA NA 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.
-
-
SciScore for 10.1101/2021.01.05.21249131: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The study protocol received ethical review and approval of the Institutional Review Board of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria. Randomization 62 patients were randomized to 3 treatment groups. Blinding not detected. Power Analysis not detected. Sex as a biological variable ectin B Number per arm 21 21 Age (years) 48.3 39.7 Male 15 14 Female 6 7 Symptoms Fever 30% 42.8% Headache 50% 57% Cough 30% 19% Dyspnea 20% 23% Signs Anosmia/Ageusi 25% 15% a Resp. rate /min 26(6.2 23.6(6 ) . 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 …
SciScore for 10.1101/2021.01.05.21249131: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The study protocol received ethical review and approval of the Institutional Review Board of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria. Randomization 62 patients were randomized to 3 treatment groups. Blinding not detected. Power Analysis not detected. Sex as a biological variable ectin B Number per arm 21 21 Age (years) 48.3 39.7 Male 15 14 Female 6 7 Symptoms Fever 30% 42.8% Headache 50% 57% Cough 30% 19% Dyspnea 20% 23% Signs Anosmia/Ageusi 25% 15% a Resp. rate /min 26(6.2 23.6(6 ) . 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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.
Results from TrialIdentifier: No clinical trial numbers were referenced.
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.
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 checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.
-
