COVID-19 Clinical Trials and Expanded Access

To register pathological events occurring to all acute coronary syndrome patients comingto Assiut university heart hospital through one year during COVID- 19 pandemic

The purpose of this study is to monitor short-term changes in tissue oxygen saturationand local blood flow as results of changing from supine to prone position in ARDSCOVID-19 patients

The study aim to test proof of concept of CBD treatment for efficacy and safety inpatients suffering with mild COVID-19 infection. The CBD will be delivered via oildroplets not containing THC, compared to placebo.

Primary objectives Part 1: - To evaluate the safety and tolerability of COR-101 compared to placeboSecondary objectives Part 1: - To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 - To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

This study consists of two parts.Part A (Phase I):A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assessthe Safety, Pharmacokinetics, Pharmacodynamics of MRG-001Part B (Phase 2):A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Studyin Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess theSafety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

A randomized, double-blind, placebo-controlled international multicenter clinical trialdesign will be adopted. A total of 29,000 subjects aged 18 years and above are planned tobe recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years andabove in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years andabove will be recruited outside China. Safety and immunogenicity will be evaluated amongthe Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among thesubjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 andabove from outside China and all subjects from China will be selected as theimmunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2neutralizing antibody and RBD protein binding antibody will be detected by blood samplingbefore vaccination, 14 days and 6 months after full course of vaccination to evaluate theimmunogenicity and immune persistence.

The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.

Multicenter observational study of diagnostic test validation (Research Involving theHuman Person, type 3) In addition to the diagnosis by the reference method(nasopharyngeal swab), the patient will be asked to provide a saliva sample via asalivary spit. The clinical circumstances of the diagnosis, the age of the patient, theassociated terrain (diabetes, immunodepression, pregnancy) will be noted. Thenasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining sampleswill be frozen and stored at the CRB before being sent to the University Hospital of Caenfor analysis and concordance verification.The expected benefits are:Possibility of repeating tests in the same person more easily due to the absence of painand thus reduce the barriers to diagnosis and screening.Possibility of self-sampling, which could simply be sent to the laboratory, which wouldrelieve the diagnostic sites that mobilize staff and require a fairly heavy organization.Avoid long waiting lines that can be an obstacle and lead to a renunciation of thediagnosis.

Initially, it was suspected that Covid-19 would primarily affect the airways, but severalstudies have now shown that it is a disease with multisystem manifestations. Covid-19 hasthe potential to affect physical, cognitive, and psychological functions in multipleways. It has been clear that a significant proportion of patients with Covid-19 developlong-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describethe wide range of prolonged symptoms following the infection. Patients who have been inhospital for Covid-19 for a long time may need specialized rehabilitation, however, alsonon-hospitalized patients with mild symptoms may need specific rehabilitation to be ableto meet the complex symptoms and problems that may arise. Previous studies on therecovery and rehabilitation after other coronavirus shows the importance to developtailored interventions so that these patients receive appropriate rehabilitationThe aim of this study is to evaluate the effects of inspiratory muscle training on adultpatients with PACS and decreased respiratory muscle strength.A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80% or less of predicted value in inspiratory muscle strength (maximal inspiratorypressure) will be eligible for enrollment. Patients will be randomized either to anintervention group or a control group. The intervention will consist of inspiratorymuscle training performed twice daily for 8 weeks. This will be combined with an 8-weekphysical exercise training program. The control group will perform the same physicalexercise training according to standard care. All measurements will be performed atbaseline and after 8 weeks.Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximalexpiratory pressure, pulmonary function, physical capacity, physical activity,respiratory status and symptoms, health-related quality of life, work ability, fatigue,self-reported outcome measure of physical function and voice function.Covid-19 has the potential to affect physical, cognitive, and psychological functions inmultiple ways and lead to a negative impact on quality of life in the long-termperspective. Therefore, development of a rehabilitation program with specific tailoredinterventions will be necessary to improve physical and psychological function, as wellas health-related quality of life and work ability.