View clinical trials related to Coronavirus Disease 2019.
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Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age. Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.
Popular topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine. Overall design:An open experimental design was used in this study Study population:The study involved people 18 years of age and older. Test groups: All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib in patients hospitalized with moderate-to-severe COVID-19 (based on World Health Organization [WHO] Ordinal Scale for Clinical Improvement). Both famotidine and celecoxib separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and appear to have separate and complementary mechanisms of action.
This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.
This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.
The objective of the study is to evaluate the anti-viral efficacy of 3 different dosages of masitinib in patients with symptomatic mild to moderate COVID-19.
The IN2COVID Study is a 2-staged phase I/II double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of AP-003 (Interferon α2b) when administered via inhalation twice daily for 10 days. Participants will have a final visit at Day 11. A lead-in phase 1 substudy will be performed with at least 18 healthy adult male subjects to assess safety and tolerability of inhaled AP-003 compared to placebo for 10 days. Two cohorts of 9 subjects will be randomly assigned to receive two doses of inhaled AP-003 or placebo with an allocation ratio of 2:1. The first cohort will assess a dose of 2.5 MIU of inhaled AP-003. If no adverse events are observed, the second cohort will be conducted using a dose of 5 MIU of inhaled AP-003. Maximum tolerated dose will be determined in this phase 1 substudy. After the completion of phase 1, the study will continue with a phase 2 treatment RCT in patients with COVID-19. In this phase, 150 adults with mild or moderate COVID-19 demonstrated by SARS-CoV-2 positive polymerase chain reaction (PCR) ≤ 5 days at enrollment will be randomized 1:1 (75 in each arm) to receive nebulized AP-003 or identical placebo twice daily during 10 days.
The Covid-19 pandemic and its health and societal consequences raise fears of a deterioration in the management of non-Covid-19 pathologies, particularly those requiring rapid treatment. These fears relate in particular to strokes and acute myocardial infarctions (AMI), the two most frequent diseases, for which emergency treatment is a major factor in the vital and functional prognosis of patients. They are based on activity data from the emergency services, which have shown a sharp drop in admissions for AMI and strokes at the start of the pandemic. This drop is interpreted as being partly linked to a tendency for patients to delay or even give up care, which may be explained by fear of contamination, the desire not to solicit already overworked healthcare professionals and overload in emergency structures. In addition, studies have shown that the time required to treat AMI during the pandemic phase in China has been extended due to the new organizations set up in healthcare institutions in connection with this major health event. In addition, certain inequalities in access to care, already identified during the non- pandemic period among AMI and stroke patients, are likely to be accentuated by the new healthcare organizations set up during the pandemic period. The investigators are interested in the impact of changes in healthcare utilization and reorganization within hospitals, related to the Covid-19 pandemic, on the quality of the care pathway for stroke and AMI patients in the Aquitaine region. The investigators also study the role of the socio-demographic, socio-economic and geographical characteristics of these patients as factors of inequality of access to care during this period. The project is based on data collected within the Aquitaine Cardio-Neuro-Vascular Registries (CNV), an exhaustive cohort of stroke and AMI patients treated by a health care institution in Aquitaine. They are an excellent tool for describing the care pathway and outcomes of these patients, from the onset of symptoms to the end of the acute episode. An additional collection is planned to collect all the organizations and activities set up within the hospitals in Aquitaine. The study period, from January 2019 to August 2020, provides sufficient time before lockdown and after the date of the end of lockdown, to analyze trends in the quality of pathways, according to the various reorganizations of the health system and changes in the use of care linked to the management of the Covid-19 pandemic. The project identifies the reorganizations with the most striking consequences on the quality of care for patients suffering from non Covid-19 pathologies. It analyzes the changes in the behaviour of patients and their family and caregivers in their use of care during the Covid-19 pandemic and their impact on the care pathways and results. It contributes to the policy of reducing inequalities in access to care and to the definition of a health strategy in the event of a major health crisis.
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2.