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Covid19 clinical trials

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NCT ID: NCT05413694 Not yet recruiting - COVID-19 Clinical Trials

Epidemiological Monitoring of COVID-19 Patients Hospitalized on Reunion Island

COVIDEPI-SUIV'
Start date: July 2022
Phase: N/A
Study type: Interventional

The island of Reunion, a French overseas department of 860,000 inhabitants, located in the Indian Ocean (OI) zone, recorded its first case of COVID-19 on March 11, 2020. The epidemic, which was described as not very severe during the year 2020 in Reunion was much more intense and more deadly in 2021, with the arrival of the new variants (South African and Indian) and exploded at the beginning of the year 2022 (variant Omicron). Reunion has a specific island context both climato-geographically and demographically. Indeed, this French island located in the southern hemisphere in the middle of the Indian Ocean (OI) has a tropical climate and a multi-ethnic population, younger than in mainland France (16% are over 60 years old). It is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (>10%), recognized as factors favoring severe clinical forms of COVID-19. as well as "persistent COVID-19". This study will allow the constitution of a large-scale French cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.

NCT ID: NCT05413642 Withdrawn - COVID-19 Clinical Trials

COVID-19 Algorithm Treatment at Home

COVER-HOME
Start date: July 1, 2023
Phase: Phase 3
Study type: Interventional

The newly recognised disease COVID-19 is caused by the Severe-Acute-Respiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clinical spectrum of SARS-CoV-2 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness and mild extrapulmonary symptoms, and severe viral pneumonia with respiratory failure and even death. For COVID-19, most primary care physicians have initially treated their patients at home according to their judgment, with various treatment regimens they believe are most appropriate based on their experience/expertise. We recently published a note on how we were treating patients at home based on the pathophysiology underlining the mild/moderate symptoms at the onset of the illness and the proposal of simple drugs that theoretically better fit these mechanisms. Because the common early mild symptoms of COVID-19 highlight a systemic inflammatory process, there is the recommendation of using anti-inflammatory agents to limit excessive host inflammatory responses to the viral infection, including non-steroidal anti-inflammatory drugs and corticosteroids. Moreover, COVID-19 patients are exposed to the risk of thromboembolic events and anticoagulant prophylaxis is recommended even at home, in particular settings, unless contraindicated. In an academic matched-cohort study, we found that early treatment of COVID-19 patients at home by their family doctors according to the proposed recommendation regimen almost completely prevented the need for hospital admission (the most clinically relevant outcome of the study along with death) due to progression toward more severe illness (2 out of 90 patients), compared to patients in the 'control' cohort who were treated at home according to their family physician's assessments (13 out of 90 patients). However, the rate of hospitalization was a secondary outcome of the study and the possibility of a casual finding cannot be definitely excluded. Moreover, these findings were achieved in a retrospective observational study with two matched cohorts of COVID-19 patients, a possible additional limitation of the robustness of the conclusions that would deserve further validation. Thus, we have considered the observed reduction in patient hospitalization a hypothesis generating finding to be confirmed. In this pragmatic, prospective, three-months, cluster randomized, open-label, blinded endpoint (PROBE) clinical trial, we will compare two groups of family doctors according to a randomized approach, who will treat their COVID19-patients with the proposed recommendation algorithm or other treatment regimens they normally feel appropriate according to their usual clinical practice, and monitor them longitudinally up to 3 months. Our working hypothesis is that following the proposed recommendation algorithm the early COVID-19-related inflammatory process is limited, preventing the need of hospital admission at larger extent than with other therapeutic approaches also targeting early symptoms of the illness at home. Should the findings be confirmed, the tested standardized treatment protocol would achieve major benefits for patients with early COVID-19 in particular in relation to a remarkably reduced risk of hospitalization that is expected to translate into reduced morbility and, possibly, mortality. Notably, these expected clinical benefits would be associated with remarkably reduced treatment costs related to reduced hospitalization.

NCT ID: NCT05413577 Completed - Stress Clinical Trials

Reducing Parental Stress Via Instant Messaging During COVID-19 Pandemic: A Randomized Controlled Trial

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This research investigated the effects of mindfulness practice on mental wellbeing and parenting behaviour, with the instruction recordings delivered via existing instant messaging applications, including Whatsapp and Signal. The two-week mindfulness program targeted parents with children in Nursery, Kindergarten to Primary School. Due to the suspension of schools, work from home policies, parents spend increased amount of time with their children. News reports have indicated that with the mounting care taking responsibilities and downturn of economy amidst the epidemic, parents have been experiencing higher stress that may negatively impact their wellbeing and parent-child relationship. This study delivered an app-based intervention that aims at enhancing mindful parenting at the time of corona, where social distancing is emphasized.

NCT ID: NCT05412173 Completed - COVID-19 Clinical Trials

Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers

Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), based on the analysis of adverse events (AEs); 2. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Molnupiravir, capsules, 200 mg (Valenta Pharm JSC, Russia), and Lagevrio, capsules, 200 mg (Merck Sharp & Dohme (UK) Limited, UK), in healthy volunteers in fasted conditions.

NCT ID: NCT05411575 Withdrawn - COVID-19 Clinical Trials

Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)

LEONARDO
Start date: July 19, 2022
Phase: Phase 2
Study type: Interventional

This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age, - with acute respiratory failure related to COVID-19 and - Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure - without invasive mechanical ventilation and - requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation > 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...). Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

NCT ID: NCT05411562 Recruiting - COVID-19 Clinical Trials

COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

NOSO-COVID
Start date: November 9, 2020
Phase:
Study type: Observational

This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

NCT ID: NCT05411471 Completed - COVID-19 Clinical Trials

Immunogenicity and Safety Study of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Start date: June 8, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.

NCT ID: NCT05411458 Completed - COVID-19 Clinical Trials

Effects of Telerehabilitative Aerobic and Relaxation Exercises Patients With Type 2 Diabetes With and Without COVID-19

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Type-2 Diabetes Mellitus (DM) disease, like other chronic diseases, is a group of diseases that are adversely affected by the COVID-19 pandemic.This study was planned to examine the effect of COVID-19 disease on patients with Type-2 DM and to investigate the effects of progressive relaxation exercises to be given as tele-rehabilitative on stress, anxiety and blood glucose levels and HbA1c value.

NCT ID: NCT05410808 Completed - Fibromyalgia Clinical Trials

Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the Coronavirus Disease 2019 Pandemic

Start date: December 1, 2021
Phase:
Study type: Observational

Fibromyalgia patients and controls living in the same household will be evaluated for levels of resilience, covid-19 related anxiety, coronavirus disease 2019 related obsession, quality of life and pain and comparisons and correlation analyses will be carried out.

NCT ID: NCT05409300 Active, not recruiting - COVID-19 Clinical Trials

Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea

CovicompareG
Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.