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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Progression 51% Improvement Relative Risk Viral clearance, day 7 -50% Viral clearance, day7, PP -56% Time to viral- -17% HCQ  Nimitvilai et al.  EARLY TREATMENT  RCT Is early treatment with HCQ + combined treatments beneficial for COVID-19? RCT 113 patients in Thailand (December 2020 - April 2021) Trial compares with ivermectin and zinc sulfate Worse viral clearance with HCQ + combined treatments (not stat. sig., p=0.12) c19hcq.org Nimitvilai et al., J. Global Infectiou.., Jun 2022 Favors HCQ Favors ivermectin a..

A randomized controlled trial of combined ivermectin and zinc sulfate versus combined hydroxychloroquine, darunavir/ritonavir, and zinc sulfate among adult patients with asymptomatic or mild coronavirus-19 infection

Nimitvilai et al., Journal of Global Infectious Diseases, doi:10.4103/jgid.jgid_281_21, NCT02045069
Jun 2022  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now known with p < 0.00000000001 from 421 studies, recognized in 42 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments. c19hcq.org
RCT low-risk patients in Thailand comparing HCQ, darunavir/ritonavir, and zinc, with ivermectin and zinc, showing no significant differences. All patients recovered. 65% of patients were asymptomatic at baseline, 26% were PCR- at baseline, and 84% were culture negative at baseline. The percentage of patients symptomatic at baseline was 15% higher for ivermectin.
The reported trial id NCT02045069 (history) is a 2014 dengue trial with a status of recruiting clinicaltrials.gov. Authors claim both treatments had no clinical benefit, however all patients were discharged from quarantine as planned between 10-14 days, and there was no control group. Authors claim there was "no clear evidence of antiviral effects for the control arm", however there was no control arm. Authors indicate that all patients were discharged within 14 days, however they report that one patient had Ct 22.11 at day 12.
Study covers HCQ and ivermectin.
risk of progression, 50.9% lower, RR 0.49, p = 0.62, treatment 1 of 57 (1.8%), control 2 of 56 (3.6%), NNT 55.
risk of no viral clearance, 49.7% higher, RR 1.50, p = 0.12, treatment 25 of 56 (44.6%), control 17 of 57 (29.8%), mid-recovery, day 7, modified intention-to-treat.
risk of no viral clearance, 56.0% higher, RR 1.56, p = 0.048, treatment 24 of 38 (63.2%), control 17 of 42 (40.5%), mid-recovery, day 7, per-protocol.
time to viral-, 16.7% higher, relative time 1.17, p = 0.42, treatment 57, control 56.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Nimitvilai et al., 29 Jun 2022, Randomized Controlled Trial, Thailand, peer-reviewed, 10 authors, study period December 2020 - April 2021, this trial compares with another treatment - results may be better when compared to placebo, this trial uses multiple treatments in the treatment arm (combined with darunavir/ritonavir and zinc sulfate) - results of individual treatments may vary, trial NCT02045069 (history). Contact: ysuputtamongkol@gmail.com.
This PaperHCQAll
A randomized controlled trial of combined ivermectin and zinc sulfate versus combined hydroxychloroquine, darunavir/ritonavir, and zinc sulfate among adult patients with asymptomatic or mild coronavirus-19 infection
Prof. Yupin Yupin Suputtamongkol, Sireethorn Nimitvilai, Ussanee Poolvivatchaikarn, Dechatorn Rassamekulthana, Nuttawut Rongkiettechakorn, Anek Mungaomklang, Susan Assanasaen, Ekkarat Wongsawat, Chompunuch Boonarkart, Waritta Sawaengdee
Journal of Global Infectious Diseases, doi:10.4103/jgid.jgid_281_21
IntRoductIon The outbreak of coronavirus-19 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has caused an ongoing burden on health-care systems worldwide. Both the asymptomatic and symptomatic patients had similar viral loads. Published data showed that the transmission from asymptomatic or mild infection is very high. [1, 2] The administration of an effective oral antiviral therapy would be useful for transmission blocking or reducing onward transmission by these population. In addition, early treatment of these patients may prevent progression to severe COVID-19. However, an effective treatment option is not yet available for SARS-CoV-2 infection. Ivermectin is a safe and widely used antiparasitic drug with known in vitro efficacy against several single-strain RNA viruses, including SARS-CoV-2. [3] Ivermectin has been Introduction: Ivermectin, hydroxychloroquine (HQ), and darunavir/ritonavir are widely prescribed as an oral treatment for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection despite their uncertainty of clinical benefit. The objective is to determine the safety and the efficacies of two treatment regimens against SARS-CoV-2 infection. Methods: We conducted an open-labeled, randomized, controlled trial to compare the efficacy between a 3-day course of once-daily high-dose oral ivermectin plus zinc sulfate (Group A) and a combination of HQ, darunavir/ritonavir, and zinc sulfate (HQ + antiretroviral, Group B) for 5 days in asymptomatic or mild SARS-CoV-2 infection. The study period was between December 2020 and April 2021. Results: Overall, 113 patients were randomized and analyzed (57 patients in Group A and 56 patients in Group B). The median duration to achieve the virological outcome of either undetected or cycle threshold (Ct) for N gene of SARS-CoV-2 by real-time polymerase chain reaction was 6 days (95% confidence interval [CI] 5.3-6.7) versus 7 days (95% CI: 5.4-8.6) in Group A and Group B, respectively (P = 0.419) in the modified intention-to-treat population. All patients were discharged from hospital quarantine as planned. Two patients in Group A and one patient in Group B were considered clinically worsening and received 10 days of favipiravir treatment. There was no serious adverse event found in both groups. Conclusion: We demonstrated that both treatment regimens were safe, but both treatment regimens had no virological or clinical benefit. Based on this result and current data, there is no supporting evidence for the clinical benefit of ivermectin for coronavirus-19.
Research quality and ethics statement The authors followed applicable EQUATOR Network (http:// www.equator-network.org/) guidelines during this research project. This study was approved by the appropriate Institutional Review Board of all study sites, the Council of Architecture (COA 323/2563), and (COA 002/2021). The trial was registered with ClinicalTrials.gov (NCT02045069). Conflicts of interest There are no conflicts of interest.
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