Active clinical trials for "COVID-19"

This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).

The COVID-19 pandemic has become a major public health challenge, and the treatment options for the disease are currently limited. The commonly used oral small-molecule anti-COVID-19 drugs in China are Nirmatrelvir-Ritonavir and Azvudine. These drugs have been tested in pre-marketing clinical trials in patients with non-severe COVID-19 infection and have demonstrated therapeutic effects in inhibiting virus transmission and preventing disease progression. However, until now, the efficacy and safety of these drugs in patients with moderate to severe COVID-19 infections remains unclear. Therefore, this study is aiming to compare the efficacy and safety of Azvudine and Nirmatrelvir-Ritonavir in moderate to severe COVID-19 infections. This study will be a multicenter, randomized, controlled clinical trial study in patients hospitalized with moderate to severe COVID-19 infections. Recovery of clinical symptoms, nucleic acid negative conversion, improvement in oxygenation index, and imaging improvement will be used as study endpoints.

This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short-term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long-term follow-up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.

This research is being done to collect preliminary data on the potential of computerized "brain-training" exercises for treating Long COVID symptoms in older adults. The investigators hypothesize that computerized brain-training will be an acceptable and feasible intervention for treating Long COVID symptoms in older adults. The investigators also expect to provide initial evidence that computerized brain-training has potential for improving thinking, mood, and other aspects of everyday functioning in older adults with Long COVID.

Despite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined. IC hosts were largely excluded from the COVID-19 vaccine registration trials, though many countries recommend additional and booster doses of vaccination in this group. BOOST-IC is an adaptive randomised clinical trial (RCT) to assess the immunogenicity and safety of additional COVID-19 vaccine doses in immunocompromised (IC) people, including people with HIV, solid organ transplants (SOT) recipients or those with haematological malignancies. Briefly, the study aims to generate high-quality evidence on the immunogenicity and safety of alternative COVID-19 booster strategies against SARS-CoV-2 for IC people in Australia.

Phase II/Phase III study to evaluate the safety and efficacy of Ramatroban 75 mg tablet against Placebo in subjects hospitalized for pneumonia due to SARS-CoV-2 infection. Approximately 324 eligible subjects will be randomized in a 1:1 ratio to one of the two treatment groups. Group I: Ramatroban 75 mg tablet + Standard of care; Group II: Placebo + Standard of care. Phase 2 Primary Objective: To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Secondary Objective: To assess the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Phase 3 Primary Objective: To evaluate the efficacy of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Secondary Objective: To evaluate the safety of Ramatroban 75 mg tablet with the standard of care against Placebo with the standard of care in COVID-19 hospitalized subjects. Long COVID [Follow-up Phase- Objectives- (Phase 2 & 3)] To examine lipid mediators, specifically thromboxane A2, prostaglandin D2, F2-isoprostane and/or their metabolites in convalescent subjects after treatment. To assess the efficacy of Ramatroban administered during the acute illness in preventing/mitigating subsequent development of long COVID / PASC

The COVID-19 is closely related to severe acute respiratory syndrome (SARS) with direct and indirect effects on several systems, especially the musculoskeletal system, in addition to the respiratory system. Some of these symptoms persist for a long time, called Post-COVID-19 Syndrome, directly interfering with the functional capacity and quality of life of these patients. Pilates exercises focus on breathing, postural symmetry, trunk stabilization, flexibility, joint mobility and strengthening through the full range of motion of all joints and not isolated muscle groups. The objective of this study will be to evaluate the clinical and functional effects of a Pilates for patients post hospitalization for COVID-19. A randomized and controlled clinical trial will be conducted, with recruitment patients who have developed the severe form of COVID-19 and required at least 7 days of invasive mechanical ventilation. They will be previously randomized in a 1:1 ratio by electronic system and blindly allocated to the intervention group that will perform an exercise protocol based on the Pilates method, 2x/week, for 12 weeks in therapeutic sessions of identical protocols lasting 60 min. All patients will be evaluated before and after for six minutes walk distance test, peripheral and respiratory muscle strength and endurance, post-COVID-19 functional status, dyspnea, and quality of life. The analysis will be based on intention-to-treat principles. Descriptive statistics will be used to present the characteristics of participants in the two treatment groups. P values less than 0.05 will be considered to indicate statistical evidence of significance. The variables of dyspnea, peripheral and respiratory muscle strength, functional capacity, post-COVID functional status and HRQoL will be analyzed using linear models of repeated measures which included all values measured after randomization with baseline scores and treatment clusters as covariates. Adjusted mean differences will be tested 12 weeks after randomization and start of intervention. Multiple comparisons will be performed using the Tukey Test with p-values adjusted using the Holm procedure. Baseline variables will be evaluated as predictors and moderators of treatment effects, including terms and interaction models. Effect sizes for primary and secondary endpoints will be calculated as Cohen's d from estimated marginal means (SMD) and standard error estimates from the adjusted primary analysis. All analyzes were performed using RStudio version 0.99.486. Results: The expected results are based on the alternative hypothesis that Pilates exercises are clinically effective, improving functional performance, exercise tolerance, reducing symptoms and improving the quality of life of patients with symptoms of Post-COVID-19 Syndrome.

The aim of this study is to investigate the efficacy of a home-based pulmonary rehabilitation program with the support of teletechnology in COVID-19 survivors. The main questions it aims to answer are: The change of six-minute walk distance The change of time of one-minute sit-to-stand test The change of maximal strength of upper-limb, lower-limb and respiratory muscle The change of quality of life Participants in the home-based pulmonary rehabilitation group will receive teletechnology-assisted consultations (either by videotelephony or telephone calls) for every 1-2 weeks during the intervention period, and participants in the usual care group will not receive teletechnology-assisted consultations during the intervention period.

A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of WPV01 in patients with mild/moderate COVID-19 infection

The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are: To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects Participants for Phase I will be randomized to either JCXH-221 or placebo. In Phase 2, participants will be randomized to either JCXH-221 or a FDA approved Active comparator.