scholarly journals Clinical Trial of Efficacy and Toxicity of Disoproxil Tenofovir Fumarate and Emtricitabine for Mild to Moderate SARS-CoV-2 Infections

2021 ◽  
Author(s):  
Aldo A M Lima ◽  
Erico A G Arruda ◽  
Roberto J Pires-Neto ◽  
Melissa S Medeiros ◽  
J Quirino-Filho ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin C ◽  
Respiratory Infection ◽  
Clinical Symptoms ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Clinical Suspicion ◽  
Pharmacological Intervention ◽  
Controlled Clinical Trial ◽  
Double Blind

This study aimed to evaluate the efficacy and toxicity of tenofovir (TDF) and TDF combined with emtricitabine (TDF/FTC) in patients with mild to moderate COVID-19 infections. We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with clinical suspicion of mild to moderate respiratory infection caused by SARS-CoV-2 who were treated at an outpatient clinic. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo Vitamin C (500 mg/day). The primary parameter was the score of symptoms and predictive signs of COVID-19, assessed on the seventh day of patient follow-up. From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF group; (b) 74 in the TDF combined with FTC group; and (c) 77 in the Vitamin C group (placebo). Of the 226 patients, 139 (62%) were positive for SARS-CoV-2. Fever (37.8oC), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical symptoms or signs were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical symptoms and signs between treatment groups. Patients with mild to moderate infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1β, IL-6 and TNF-α compared to patients without infection. Patients with mild to moderate respiratory infection, with fever (37.8oC), loss of smell, loss of taste and two or more symptoms, have a better prediction for the diagnosis of COVID-19. Patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score in mild to moderate respiratory infection in patients with SARS-CoV-2 compared to the Vitamin C group (placebo).

scholarly journals Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahsa Miryan ◽  
Mohammad Bagherniya ◽  
Amirhossein Sahebkar ◽  
Davood Soleimani ◽  
Mohammad Hossein Rouhani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Inflammatory Mediators ◽  
Disease Duration ◽  
Clinical Symptoms ◽  
Clinical Signs ◽  
Inflammatory Factors ◽  
Double Blind ◽  
Full Protocol ◽  
To Receive

Abstract Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529. The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Randomized, double-blind, placebo-controlled clinical trial measuring the effect of a dietetic food on dermatologic scoring and pruritus in dogs with atopic dermatitis

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Miguel Sánchez de Santiago ◽  
José Luis González Arribas ◽  
Yolanda Moral Llamas ◽  
Iveta Becvarova ◽  
Hein Meyer
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Control Diet ◽  
Clinical Signs ◽  
Controlled Clinical Trial ◽  
Omega 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Study Results ◽  
Multimodal Management

Abstract Background Canine atopic dermatitis (AD) is a common condition that often requires multimodal therapy. Including a diet in the multimodal management of AD may reduce medication doses, saving pet owners money and reducing side effects. The objective of this randomized, double-blind, placebo-controlled clinical trial was to determine if a diet fortified in antioxidants, polyphenols, and omega-3 fatty acids can reduce the clinical signs of AD. Forty client-owned dogs with AD were enrolled in the study and assigned to either an enriched diet (diet B) or control diet (diet A) for 60-days. CADESI-4 index scores and owner-reported pruritus scores were measured periodically. Results Total CADESI-4 index scores for dogs eating diet B were lower on day 60 compared to baseline (P = 0.003). There was no statistical difference in scores for dogs eating diet A over a 60-day period. Diet B dogs had 25 and 49% reductions in CADESI-4 index scores on days 30 and 60, respectively (P = 0.0007) while diet A had no change over the study period. When comparing the percent change in owner-reported pruritus scores, diet B also performed better than diet A. By day 60, owners feeding diet B to their dogs reported a significant reduction (P < 0.0001) of 46.4% in itching, while those on diet A reported a 26.8% reduction, which was not statistically significant (P = 0.08). Conclusions These study results demonstrate feeding a diet enriched with ingredients to improve skin health and reduce inflammation improves the clinical signs of AD in dogs.

scholarly journals The Effect of Structured Exercise Compared with Education on Neuropathic Signs and Symptoms in People at Risk of Neuropathic Diabetic Foot Ulcers: A Randomized Clinical Trial

Medicina ◽  
2021 ◽  
Vol 58 (1) ◽  
pp. 59
Author(s):  
Byron M. Perrin ◽  
Jessica Southon ◽  
Jane McCaig ◽  
Isabelle Skinner ◽  
Timothy C. Skinner ◽  
...  
Keyword(s):  
Clinical Trial ◽  
At Risk ◽  
Peripheral Neuropathy ◽  
Outcome Measures ◽  
Clinical Symptoms ◽  
Clinical Signs ◽  
Signs And Symptoms ◽  
Secondary Outcome ◽  
Lifestyle Interventions ◽  
Post Intervention

Background and Objectives: Lifestyle interventions such as exercise prescription and education may play a role in the management of peripheral neuropathy in people with diabetes. The aim of this study was to determine the effect of undertaking an exercise program in comparison with an education program on the signs and symptoms of peripheral neuropathy in people with diabetes at risk of neuropathic foot ulceration. Materials and Methods: Twenty-four adult participants with diabetes and peripheral neuropathy were enrolled in this parallel-group, assessor blinded, randomised clinical trial. Participants were randomly allocated to one of two 8-week lifestyle interventions, exercise or education. The primary outcome measures were the two-part Michigan Neuropathy Screening Instrument (MNSI) and vibratory perception threshold (VPT). Secondary outcome measures included aerobic fitness, balance and lower limb muscular endurance. Results: Participants in both lifestyle interventions significantly improved over time for MNSI clinical signs (MD: −1.04, 95% CI: −1.68 to −0.40), MNSI symptoms (MD: −1.11, 95% CI: −1.89 to −0.33) and VPT (MD: −4.22, 95% CI: −8.04 to −0.40). Although the interaction effects did not reach significance, changes in values from pre to post intervention favoured exercise in comparison to control for MNSI clinical signs (MD −0.42, 95% CI −1.72 to 0.90), MNSI clinical symptoms (MD −0.38, 95% CI −1.96 to 1.2) and VPT (MD −4.22, 95% CI −12.09 to 3.65). Conclusion: Eight weeks of exercise training or lifestyle education can improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy. These findings support a role for lifestyle interventions in the management of peripheral neuropathy.

scholarly journals High dose vitamin C in sepsis (HDVCIS): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bing Zhao ◽  
Mengjiao Li ◽  
Jian Li ◽  
Leshan Liu ◽  
Yihui Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin C ◽  
Animal Studies ◽  
Controlled Trial ◽  
Small Scale ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
High Dose Vitamin

Abstract Sepsis is an inflammatory syndrome with life-threatening organ dysfunction resulting from a dysregulated host response to infection. Although the treatment for sepsis has improved a lot in the last 30 years, sepsis related mortality remains high. In the recent 10 years, high dose intravenous injection of vitamin C, the first line antioxidant of human, has received more and more attention in the field of critical care, its beneficial effect has been demonstrated by several small scale clinical trial and animal studies, but the effect of high dose vitamin C on sepsis in a larger trial seems warranted in further study. Here we will conduct a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial named as HDVCIS. The trial protocol has been approved by Clinical Trail Ethics Committee of Ruijin Hospital of Shanghai JiaoTong University School of Medicine. This trial has been registered in Chinese Clinical Trial Registry (ChiCTR1800017633) in August 7, 2018. Patients will be recruited from 4 medical centers in China. Its object is to testify the efficacy and safety of high dose vitamin C in the treatment of sepsis.

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