scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial

2020 ◽  
Author(s):  
Maria Isabel F Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Maira N Benatti ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Adverse Events ◽  
Interim Analysis ◽  
Supplemental Oxygen ◽  
Serum Lactate Dehydrogenase ◽  
Controlled Clinical Trial ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Double Blinded

Introduction. Neutrophilia and high levels of proinflammatory cytokines and other mediators of inflammation are common finds in patients with severe acute respiratory syndrome due to COVID-19, a dramatic condition for which there is no specific treatment, but supportive care and attempts to control the systemic inflammation. By its action on leukocytes, we propose colchicine as an intervention worthy of being tested. Objective. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. Methods. We present the interim analysis of a single-center randomized, double-blinded, placebo controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 38 patients allocated 1:1 from April 11 to July 06, 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was ≥ 80 kg. Endpoints. The primary endpoints were the need for supplemental oxygen; time of hospitalization; need for admission and length of stay in intensive care unit; and death rate and causes of mortality. As secondary endpoints, we assessed: serum C-reactive protein, serum Lactate dehydrogenase and relation neutrophil to lymphocyte of peripheral blood samples from day zero to day 7; the number, type, and severity of adverse events; frequency of interruption of the study protocol due to adverse events; and frequency of QT interval above 450 ms. Results. Thirty-five patients (18 for Placebo and 17 for Colchicine) completed the study. Both groups were comparable in terms of demographic, clinical and laboratory data at baseline. Median (and interquartile range) time of need for supplemental oxygen was 3.0 (1.5-6.5) days for the Colchicine group and 7.0 (3.0-8.5) days for Placebo group (p = 0.02). Median (IQR) time of hospitalization was 6.0 (4.0-8.5) days for the Colchicine group and 8.5 (5.5-11.0) days for Placebo group (p = 0.03). At day 2, 53% vs 83% of patients maintained the need for supplemental oxygen, while at day 7 the values were 6% vs 39%, in the Colchicine and Placebo groups, respectively (log rank; p = 0.01). Hospitalization was maintained for 53% vs 78% of patients at day 5 and 6% vs 17% at day 10, for the Colchicine and Placebo groups, respectively (log rank; p = 0.01). One patient per group needed admission to ICU. No recruited patient died. At day 4, patients of Colchicine group presented significant reduction of serum C-reactive protein compared to baseline (p < 0.001). The majority of adverse events were mild and did not lead to patient withdrawal. Diarrhea was more frequent in the Colchicine group (p = 0.17). Cardiac adverse events were absent. Discussion. The use of colchicine reduced the length of both, supplemental oxygen therapy and hospitalization. Shortly less than half of the patients of the Colchicine group stopped receiving supplemental oxygen until day 2. Clinical improvement was in parallel with a reduction on serum levels of C-reactive protein. The drug was safe and well tolerated. Colchicine may be considered a beneficial and not expensive option for COVID-19 treatment. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalized patients with moderate to severe COVID-19.

scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001455 ◽  
Author(s):  
Maria Isabel Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Pamella Indira Menezes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Standard Treatment ◽  
Supplemental Oxygen ◽  
Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Primary Endpoints ◽  
Registration Number ◽  
Double Blinded ◽  
Supplemental Oxygen Therapy

ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate.ResultsSeventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0–6.0) days for the colchicine group and 6.5 (4.0–9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0–9.0) days for the colchicine group and 9.0 (7.0–12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26).ConclusionColchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19.Trial registration numberRBR-8jyhxh.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e024968 ◽  
Author(s):  
Mingyan Huang ◽  
Guang Chen ◽  
Qingya Guan ◽  
Chao Liu ◽  
Qing Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Intervention Group ◽  
Blood Lipid ◽  
Controlled Clinical Trial ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Double Blinded

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.

A randomized, double-blinded clinical trial of royal jelly intake for anticancer effects and suppressing adverse events in renal cell carcinoma patients treated with tyrosine kinase inhibitors.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 697-697
Author(s):  
Yasuyoshi Miyata ◽  
Kojiro Ohba ◽  
Tomohiro Matsuo ◽  
Kensuke Mitsunari ◽  
Hideki Sakai
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Placebo Group ◽  
Adverse Events ◽  
Renal Cell ◽  
Royal Jelly ◽  
Kinase Inhibitors ◽  
Significant Difference ◽  
Anti Cancer ◽  
Double Blinded

697 Background: Royal jelly (RJ) is a honey bee product secreted from the mandibular glands and hypopharyngeal glands of worker honeybees. RJ has anti-allergy, anti-inflammatory, and immunomodulatory effects. RJ has been reported to improve the anti-cancer effects and suppress the adverse effects of chemotherapeutic agents. The main aim is to clarify the clinical effects of oral intake of RJ in renal cell carcinoma (RCC) patients treated with tyrosine kinase inhibitors (TKIs). Methods: A randomized, controlled, double-blinded clinical trial with reduction of tumor size and frequencies of adverse events as endpoints was performed in 33 RCC patients who received TKIs in Nagasaki University Hospital. Patients were divided into RJ (n = 16) and placebo (n = 17) groups, and there was no significant difference in all clinical and pathological parameters between the two groups. RJ and placebo were orally administered for 3 months. Results: In this study, 21, 8, and 3 patients were treated with sunitinib, pazopanib, and axitinib, respectively; only 1 patient was treated with sorafenib. Frequencies and severities of fatigue and anorexia in the RJ group was significantly lower than those in the placebo group ( P = 0.003 and 0.015, respectively). Such significant differences between the 2 groups were detected in patients treated with sunitinib, but not in those treated with other TKIs. The number of patients who were given an initial dose of TKIs in the RJ and placebo groups were 7 (43.8%) and 2 (11.8%), respectively, and the relative dose intensity (RDI) of the RJ group (88.6%) was significantly higher ( P = 0.016) than that in the placebo group (68.6%). Regarding anti-cancer effects, the frequency of partial response in the RJ group (n = 5; 41.7%) was higher than that in the placebo group (2; 18.2%); however, such difference was not significant ( P = 0.056). Conclusions: RJ intake can increase RDI. Although a significant difference was not observed, RJ intake observed a trend for improving anti-cancer effects by increasing RDI and maintaining quality of life.

scholarly journals Targeting the Endothelium in the Treatment of COVID-19 Early Clinical Stages: Results of a Randomized Placebo-Controlled Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 667-667
Author(s):  
Alejandro Gonzalez-Ochoa
Keyword(s):  
Placebo Group ◽  
Hospital Care ◽  
Controlled Trial ◽  
Serum Levels ◽  
Supplemental Oxygen ◽  
Thromboembolic Events ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Clinical Stages ◽  
D Dimer

Abstract Background: SARS-CoV-2 can induce several vascular endothelial-dependent systemic complications and treatment targeting endothelial cells has been suggested. Sulodexide is a heparin and glycosaminoglycan compound that has pleiotropic properties within the vascular endothelium that can prove beneficial in COVID-19 patients. Aims: We aimed to evaluate the effect of sulodexide when used in the early clinical stages of COVID-19. Methods: In an outpatient setting, we conducted a randomized placebo-controlled trial. Key inclusion criteria were patients within three days of COVID-19 clinical onset and being deemed at high risk (&gt; 50%) of severe clinical disease progression. The risk was assessed using the COVID-19 Health Complication (C19HC) calculator, which clusters the importance of various chronic comorbidities into a percentage value. After inclusion, patients were randomly assigned to receive an oral dose of sulodexide (500 LRU twice a day) or a placebo for 21 days. We performed follow-ups to assess the study endpoints via remote communication with participants or household members every seven days or as deemed necessary. Participants continued the standard of care under the supervision of their healthcare provider's primary physician. The need for hospital care was the primary outcome. Also evaluated, were the need for supplemental oxygen support, D-dimer and C reactive protein (CRP) serum levels, thromboembolic events, and mortality. Physicians responsible to determine the need for hospital care or supplemental oxygen at home were blinded to group allocation. This trial was conducted throughout the regional lockdown caused by the first wave of COVID-19 which caused some unforeseen limitations during the trial. Differences in means were calculated using the Student's t-test, while differences in percentages were assessed using the χ 2 test. Before and after serum levels in the same patients were analyzed using two paired t-tests. If the data were not normally distributed, a Wilcoxon test was used. A Kaplan-Meier curve was used to graphically compare time-to-endpoint for hospital admission and mortality. Results: 312 patients were included in the intent to treat analysis. At 21 days follow-up, 23 of 155 patients required hospitalization in the sulodexide group compared to 38 of 157 in the placebo group [relative risk (RR), 0.6; 95% confidence interval (CI), 0.38-0.97; p=0.037]. The benefit persisted with a per-protocol analysis (RR 0.6, p=0.031). Fewer patients required oxygen support in the sulodexide group [39 of 155 vs. 56 of 157; RR, 0.61; 95% CI, 0.38 to 0.9; p=0.04], and for fewer days (9 ± 7.2 in the sulodexide group vs. 11.5 ± 9.6 in the placebo group; p=0.02). Mean D-dimer levels at week 2 were significantly higher in the placebo group than in the sulodexide group (p &lt; 0.01). 28 of the 155 patients (18%) in the sulodexide group showed a D-dimer value &gt; 500 ng/dl, compared to 59 out of 157 (37.5%) in the placebo group (RR of 0.48; 95% CI of 0.31 to 0.67; p &gt; 0.01). Mean C-reactive protein levels at week 2 were lower in the sulodexide group than in the placebo group (p &lt; 0.01). There was no between-group difference concerning, hospital length of stay, thromboembolic events, major bleeding, or mortality. Conclusions: Early intervention on COVID-19 patients with sulodexide resulted in a reduced need for supplemental oxygen and hospital care. The synergistic activity of sulodexide's antithrombotic and non-antithrombotic effects on different biological targets may play an essential role in limiting disease progression. Added a low risk of bleeding or significant side effects, sulodexide might be an alternative to other oral anticoagulants which makes it a valuable medication in the outpatient treatment of COVID-19. Disclosures Gonzalez-Ochoa: Alfasigma: Consultancy, Research Funding; servier: Consultancy.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

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