scholarly journals Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial

2021 ◽  
Author(s):  
Alexandra Poinas ◽  
David Boutoille ◽  
Florence Vrignaud ◽  
Jean-Michel Nguyen ◽  
Fabrice Bonnet ◽  
...  
Keyword(s):  
Risk Factors ◽  
Skin Diseases ◽  
Low Cost ◽  
Infectious Period ◽  
Inflammatory Skin Diseases ◽  
Short Treatment ◽  
Double Blind ◽  
Number Of Patients ◽  
Registration Number ◽  
Short Treatment Duration

Abstract Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limiting its ability to replicate in the host. (2) As seen with dengue virus, tetracyclines may also be able to inhibit the replication of positive polarity single-stranded RNA viruses, such as COVID-19. (3) Tetracyclines are also modulators of innate immunity (anti-inflammatory activity), a property that has been used to treat inflammatory skin diseases for many years. They could therefore participate in limiting the cytokine storm induced by COVID-19. Moreover, the lipophilic nature of tetracyclines and their strong pulmonary penetration could allow them to inhibit viral replication at this level. Among the tetracyclines, doxycycline has three advantages: its long safety history (side effects are uncommon with no notable risks), its short treatment duration and its low cost.Methods: The trial will involve 330 patients who are positive for SARS-CoV-2 infection and have one or more risk factors for worsening the disease. These patients will be included as outpatients for early treatment of illness. For logistical reasons and in order to be able to standardise the study as much as possible, recruitment will take place in 6 hospital departments covering the whole of France. For 14 days they will be given either 200mg of doxycycline a day or placebo. Our hypothesis is a considerable reduction in the number of patients hospitalised due to COVID-19 thanks to the treatment of doxycycline.Discussion: This study could have an impact on the overcrowding of patients with COVID-19 at the hospital which is one of the major world-wide problems of this pandemic. This treatment would therefore contribute to supporting the deconfinement strategy by blocking the viral infection early and reducing the infectious period.Trial Registration: On ClinicalTrials.gov, registration number NCT04371952, first published on 30 April 2020.

scholarly journals Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial

2020 ◽  
Author(s):  
Alexandra Poinas ◽  
David Boutoille ◽  
Florence Vrignaud ◽  
Jean-Michel Nguyen ◽  
Fabrice Bonnet ◽  
...  
Keyword(s):  
Risk Factors ◽  
Skin Diseases ◽  
Low Cost ◽  
Experimental Treatment ◽  
Infectious Period ◽  
Inflammatory Skin Diseases ◽  
Short Treatment ◽  
Double Blind ◽  
Number Of Patients ◽  
Registration Number

Abstract Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limiting its ability to replicate in the host. (2) As seen with dengue virus, tetracyclines may also be able to inhibit the replication of positive polarity single-stranded RNA viruses, such as COVID-19. (3) Tetracyclines are also modulators of innate immunity (anti-inflammatory activity), a property that has been used to treat inflammatory skin diseases for many years. They could therefore participate in limiting the cytokine storm induced by COVID-19. Moreover, the lipophilic nature of tetracyclines and their strong pulmonary penetration could allow them to inhibit viral replication at this level. Among the tetracyclines, doxycycline has three advantages: its long safety history (side effects are uncommon with no notable risks), its short treatment duration and its low cost.Methods: The trial will involve 330 patients who are positive for SARS-CoV-2 infection and have one or more risk factors for worsening the disease. These patients will be included in six hospitals covering the whole of France. For 14 days they will be given either 200mg of doxycycline a day or a placebo. Our hypothesis is a considerable reduction in the number of patients hospitalised due to COVID-19 thanks to the treatment of doxycycline.Discussion: This study could have an impact on general practitioners’ management of COVID-19 patients with risk factors prior to hospital admission. If kept at home under experimental treatment, these patients would help reduce the risk of spreading SARS-CoV-2 among the population. This treatment would therefore contribute to supporting the deconfinement strategy by blocking the viral infection early and reducing the infectious period.Trial Registration: On ClinicalTrials.gov, registration number NCT04371952, first published on 30 April 2020.

scholarly journals Impact of Doxycycline on COVID-19 Patients with Risk Factors: DYNAMIC, a Multi-Centre, Randomised, Placebo-Controlled, Double-Blind Trial

2021 ◽  
Author(s):  
Alexandra Poinas ◽  
David Boutoille ◽  
Florence Vrignaud ◽  
Jean-Michel Nguyen ◽  
Fabrice Bonnet ◽  
...  
Keyword(s):  
Risk Factors ◽  
Skin Diseases ◽  
Positive Polarity ◽  
Inflammatory Skin Diseases ◽  
Short Treatment ◽  
Double Blind ◽  
Chelating Activity ◽  
Number Of Patients ◽  
Registration Number ◽  
Short Treatment Duration

Abstract Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from matrix metalloproteinases. It is possible their chelating activity may help inhibit COVID-19 infection by limiting its ability to replicate in the host. (2) As seen with dengue virus, tetracyclines may also be able to inhibit the replication of positive polarity single-stranded RNA viruses, such as COVID-19. (3) Tetracyclines are also modulators of innate immunity (anti-inflammatory activity), a property that has been used to treat inflammatory skin diseases for many years. They could therefore participate in limiting the cytokine storm induced by COVID-19. Moreover, the lipophilic nature of tetracyclines and their strong pulmonary penetration could allow them to inhibit viral replication at this level. Among the tetracyclines, doxycycline has three advantages: its long safety history (side effects are uncommon with no notable risks), its short treatment duration and its low cost.Methods: The trial will involve 330 patients who are positive for SARS-CoV-2 infection and have one or more risk factors for worsening the disease. These patients will be included as outpatients for early treatment of illness. For logistical reasons and in order to be able to standardise the study as much as possible, recruitment will take place in 6 hospital departments covering the whole of France. For 14 days they will be given either 200mg of doxycycline a day or placebo. Our hypothesis is a considerable reduction in the number of patients hospitalised due to COVID-19 thanks to the treatment of doxycycline.Discussion: This study could have an impact on the overcrowding of patients with COVID-19 at the hospital which is one of the major world-wide problems of this pandemic. This treatment would therefore contribute to supporting the deconfinement strategy by blocking the viral infection early and reducing the infectious period.Trial Registration: On ClinicalTrials.gov, registration number NCT04371952, first published on 30 April 2020.

scholarly journals Impact of Doxycycline on Covid-19 Patients With Risk Factors of Disease Degradation: Dynamic, A Randomised Controlled Double-blind Trial

2020 ◽  
Author(s):  
Alexandra Poinas ◽  
David Boutoille ◽  
Florence Vrignaud ◽  
Jean-Michel Nguyen ◽  
Fabrice Bonnet ◽  
...  
Keyword(s):  
Skin Diseases ◽  
Low Cost ◽  
Experimental Treatment ◽  
Duration Of Treatment ◽  
Inflammatory Skin Diseases ◽  
Double Blind ◽  
Registration Number ◽  
Risk Patients ◽  
History Of ◽  
Randomised Controlled

Abstract Background: The DYNAMIC study is based on three properties of tetracyclines. (1) Tetracyclines are known to chelate zinc from metalloproteases (MMPs). It is possible that their chelating activity may help to inhibit COVID-19 infection by limiting its ability to replicate in the host. (2) As seen with dengue virus, tetracyclines may also be able to inhibit the replication of positive polarity single-stranded RNA viruses, such as COVID-19. (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property that has been used to treat inflammatory skin diseases for many years. They could therefore participate in limiting the cytokine storm induced by COVID-19. The lipophilic nature of tetracyclines and their strong pulmonary penetration could allow them to inhibit viral replication at this level. Among tetracyclines, the advantages of doxycycline are triple: its long history of safety (infrequent side effects with no notable risks), the short duration of treatment and its low cost.Methods: By estimating the rate of patients presenting pulmonary signs requiring hospitalisation in at-risk patients infected with COVID-19 at 25%, we hypothesise that on doxycycline, this rate would decrease to 12%. The main objective involves 2 embedded hypotheses tested successively in case of rejection of the previous one: (i) Decrease the rate of patients requiring hospitalisation, (ii) Decrease the use of mechanical ventilatory assistance.Discussion: This study could have an impact on the management of COVID-19 risk factor patientsupstream of hospitals by general practitioners. These patients,if kept at home under experimental treatment, would participate in reducing the risk of dissemination of SAR-CoV-2in the population.Thus, this treatment would contribute to supporting the deconfinement strategy through blocking the viral infection early and reducing the contagious period.Trial Registration: On ClinicalTrials.gov, registration number NCT04371952, first published on 30 April 2020.

scholarly journals Intrathecal chloroprocaine or hyperbaric prilocaine for ambulatory knee surgery? A prospective randomized study

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
E Guntz ◽  
C Vasseur ◽  
D Ifrim ◽  
A Louvard ◽  
J F Fils ◽  
...  
Keyword(s):  
Side Effects ◽  
Knee Arthroscopy ◽  
Randomized Study ◽  
Sensory Block ◽  
Double Blind Study ◽  
Double Blind ◽  
Number Of Patients ◽  
Prolonged Duration ◽  
Registration Number ◽  
Dermatomal Level

Abstract Purpose The aim of this study was to compare intrathecal 1% chloroprocaine with 2% hyperbaric prilocaine in the setting of ambulatory knee arthroscopy. We hypothesized that complete resolution of the sensory block was faster with chloroprocaine. Methods Eighty patients scheduled for knee arthroscopy were included in this prospective randomized double-blind study. Spinal anesthesia was performed with either chloroprocaine (50 mg) or hyperbaric prilocaine (50 mg). Characteristics of sensory and motor blocks and side effects were recorded. Results Mean time to full sensory block recovery was shorter with chloroprocaine (169 (56.1) min vs 248 (59.4)). The characteristics of the sensory blocks were similar at the T12 dermatome level between the two groups. Differences appeared at T10: the percentage of patients with a sensory block was higher, onset quicker and duration longer with hyperbaric prilocaine. The number of patients with a sensory block at T4 dermatome level in both groups was minimal. Times to full motor recovery were identical in both groups (85 (70–99) vs 86 (76–111) min). Time to spontaneous voiding was shorter with chloroprocaine (203 (57.6) min vs 287.3 (47.2) min). Incidence of side effects was low in both groups. Conclusions When considering the characteristics of the sensory block, the use of chloroprocaine may allow an earlier discharge of patients. Cephalic extension was to a higher dermatomal level and the sensory block at T10 level was of prolonged duration with hyperbaric prilocaine, suggesting that the choice between the two drugs should also be performed based on the level of the sensory block requested by the surgery. This study is registered in the US National Clinical Trials Registry, registration number: NCT030389, the first of February 2017, Retrospectively registered.

scholarly journals Protocol for a case–control diagnostic accuracy study to develop diagnostic criteria for psoriasis in children (DIPSOC study): a multicentre study recruiting in UK paediatric dermatology clinics

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028689
Author(s):  
Esther Burden-Teh ◽  
Ruth Murphy ◽  
Sonia Gran ◽  
Tamar Nijsten ◽  
Carolyn Hughes ◽  
...  
Keyword(s):  
Young People ◽  
Diagnostic Criteria ◽  
Skin Diseases ◽  
Specific Treatment ◽  
Service Research ◽  
Inflammatory Skin Diseases ◽  
Children And Young People ◽  
Study Results ◽  
Registration Number ◽  
Accuracy Study

IntroductionDiagnosing psoriasis in children can be challenging. Early and accurate diagnosis is important to ensure patients receive psoriasis specific treatment and monitoring. It is recognised that the physical, psychological, quality of life, financial and comorbid burden of psoriasis are significant. The aim of this study is to develop clinical examination and history-based diagnostic criteria for psoriasis in children to help differentiate psoriasis from other scaly inflammatory rashes. The criteria tested in this study were developed through a consensus study with a group of international psoriasis experts (International Psoriasis Council).Methods and analysisChildren and young people (<18 years) with psoriasis (cases) and other scaly inflammatory skin diseases (controls) diagnosed by a dermatologist are eligible for recruitment. All participants complete a single research visit including a diagnostic criteria assessment by a trained investigator blinded to the participant’s diagnosis. The reference standard of a dermatologist’s diagnosis is extracted from the medical record. Sensitivity and specificity of the consensus derived diagnostic criteria will be calculated and the best predictive criteria developed using multivariate logistic regression.Ethics and disseminationHealth Regulatory Authority and National Health Service Research Ethics Committee approvals were granted in February 2017 (REC Ref: 17/EM/0035). Dissemination will be guided by stakeholders; patients, children and young people, dermatologists, primary care and paediatric rheumatologists. The aim is to publish the study results in a high-quality peer-reviewed journal, present the findings at international academic meetings and disseminate more widely through social media and working with patient associations.Trial registration numberISRCTN98851260.

scholarly journals Spironolactone for adult female acne (SAFA): protocol for a double-blind, placebo-controlled, phase III randomised study of spironolactone as systemic therapy for acne in adult women

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e053876
Author(s):  
Susanne Renz ◽  
Fay Chinnery ◽  
Beth Stuart ◽  
Laura Day ◽  
Ingrid Muller ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Skin Diseases ◽  
Topical Therapy ◽  
Subscale Score ◽  
Phase Iii ◽  
Adult Women ◽  
Inflammatory Skin Diseases ◽  
Double Blind ◽  
Randomised Study

IntroductionAcne is one of the most common inflammatory skin diseases worldwide and can have significant psychosocial impact and cause permanent scarring. Spironolactone, a potassium-sparing diuretic, has antiandrogenic properties, potentially reducing sebum production and hyperkeratinisation in acne-prone follicles. Dermatologists have prescribed spironolactone for acne in women for over 30 years, but robust clinical study data are lacking. This study seeks to evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women.Methods and analysisWomen (≥18 years) with persistent facial acne requiring systemic therapy are randomised to receive one tablet per day of 50 mg spironolactone or a matched placebo until week 6, increasing to up to two tablets per day (total of 100 mg spironolactone or matched placebo) until week 24, along with usual topical therapy if desired. Study treatment stops at week 24; participants are informed of their treatment allocation and enter an unblinded observational follow-up period for up to 6 months (up to week 52 after baseline). Primary outcome is the Acne-specific Quality of Life (Acne-QoL) symptom subscale score at week 12. Secondary outcomes include Acne-QoL total and subscales; participant acne self-assessment recorded on a 6-point Likert scale at 6, 12, 24 weeks and up to 52 weeks; Investigator’s Global Assessment at weeks 6 and 12; cost and cost effectiveness are assessed over 24 weeks. Aiming to detect a group difference of 2 points on the Acne-QoL symptom subscale (SD 5.8, effect size 0.35), allowing for 20% loss to follow-up, gives a sample size of 398 participants.Ethics and disseminationThis protocol was approved by Wales Research Ethics Committee (18/WA/0420). Follow-up to be completed in early 2022. Findings will be disseminated to participants, peer-reviewed journals, networks and patient groups, on social media, on the study website and the Southampton Clinical Trials Unit website to maximise impact.Trial registration numberISRCTN12892056;Pre-results.

Sign in / Sign up

Export Citation Format

Share Document