Pushkin, Saint Petersburg, Russian Federation
Mi-RNA and COVID-19
Phase
N/ASpan
405 weeksSponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Physiological and QoL Benefits of Qi-Gong in Post-acute Sequelae of Covid-19
Phase
N/ASpan
18 weeksSponsor
POCHIWURecruiting
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
Phase
N/ASpan
161 weeksSponsor
Azienda Ospedaliero, Universitaria PisanaRecruiting
Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
forty idiopathic chronic fatigue (ICF) patients will be randomly assigned into two equal groups (n=20) 1. Study group (20 patients) this group will be supervised daily, except Fridays, during the 60-minute session of 12-week BET) or waitlist group 2. Control group (20 patients)
Phase
N/ASpan
21 weeksSponsor
Cairo UniversityRecruiting
The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus
Phase
1Span
36 weeksSponsor
Rokote Laboratories Finland OyRecruiting
Healthy Volunteers
Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults
This is a randomized, comparative, multicenter, open-label, phase I/II trial in France evaluating the safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVt-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers. Phase I dose escalating - Primary Objective: To evaluate the safety of three escalating doses of a boost of an intranasal COVID-19 vaccine (LVT-001) expressing SARS-CoV-2 N/S recombinant protein in healthy volunteers. Phase II superiority trial - Primary Objective: To evaluate, using nasal swabs, the superiority of a booster dose of the selected intranasal COVID-19 vaccine (LVT-001) expressing SARS-COV-2 N/S recombinant protein versus a booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers in term of mucosal humoral immune response at Day 28. Trial population: A total of 36 and 202 healthy volunteers will be enrolled in Phase I and Phase II, respectively. Interventions: Phase I: The investigational medicinal product is the intranasal recombinant protein vaccine LVT-001 administered at Day 0 in each nostril: - Cohort A (12 participants): 20 µg - Cohort B (12 participants): 60 µg - Cohort C (12 participants): 120 µg Phase II: Two investigational medicinal products will be compared: - The selected dose of the intranasal recombinant protein vaccine LVT-001, administered at Day 0 in each nostril. - The intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech), administered as the standard of care booster. Expected Outcomes and Safety Considerations: In Phase I, healthy participants are not expected to benefit directly from the trial aside from the potential theoretical benefit of a mucosal immune response against SARS-CoV-2. Currently, no clinical trial data exist for a nasal protein vaccine in humans. The anticipated risks primarily include local nasal reactions and systemic reactions similar to those observed with other vaccines. Any adverse events following vaccination are expected to be manageable with routine care, as determined by investigators. Given that this is the first human trial of a nasal protein vaccine, the dose-escalation design ensures a safety margin, allowing for careful monitoring before progressing to the next cohort.
Phase
1/2Span
153 weeksSponsor
ANRS, Emerging Infectious DiseasesRecruiting
Healthy Volunteers
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
Phase
1Span
52 weeksSponsor
The Methodist Hospital Research InstituteRecruiting
Healthy Volunteers
Dysbiosis & Long COVID
Phase
N/ASpan
211 weeksSponsor
University of ChicagoRecruiting
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Hepatic Impairment and in Healthy Subjects with Normal Hepatic Function
Phase
1Span
20 weeksSponsor
Aligos TherapeuticsRecruiting
Healthy Volunteers
The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19
N5 Sensors has developed a device that can measure chemical concentrations at parts-per-billion levels (for example, 10 molecules in one-billion molecules is 10 parts-per-billion). This device will be used to measure a variety of chemicals in the exhaled breath of human volunteers. The measured chemicals have been selected based on their presence in the breath of subjects with COVID infection. In addition to measuring breath, samples of mucus from the nose of these same subjects will be collected. These nasal samples will be evaluated to determine the presence of the COVID virus and of COVID infection. Changes in chemicals in the breath will be compared to the presence of COVID or to infection with COVID. This comparison will determine if measurement of breath can be used as a quick and simple measure of COVID infection.
Phase
N/ASpan
28 weeksSponsor
N5 SensorsRecruiting
Healthy Volunteers