View clinical trials related to Covid19.
Filter by:Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause of admission to intensive care units (UTI). Objective: to evaluate the utility of using the prone position in patients with hypoxemic respiratory failure with COVID-19 who are with non-invasive oxygenation devices to reduce the need for invasive mechanical ventilation and mortality in this population. Material and methods: a controlled and randomized clinical trial will be carried out, which will include patients who come to the institution for medical attention with a confirmed or suspected diagnosis of COVID-19 with a severe presentation, hypoxemic respiratory failure, and non-existent oxygen therapy. invasive with a FiO2 contribution ≥40%. The patients enter 2 follow-up groups: an intervention group in which the prone position maneuver performed by the patient himself will be implemented, and another group where the patients will remain supine with the head of their bed between 30-60º. The demographic and clinical variables of these patients will be described. The primary outcome to be evaluated will be the proportion of patients requiring orotracheal intubation during their hospital stay. The secondary outcomes that will be evaluated will be hospital mortality, development of ARDS, and changes in oxygenation by determining SpO2 and SpO2/FiO2 on admission and at 1, 6, 12, 24, 48, and 72 hours after inclusion in the protocol. , as well as PaO2/FiO2 on admission and at 24 hours; the time interval between inclusion in the protocol and orotracheal intubation, use of non-invasive ventilatory therapies, days of hospital stay, days of stay in intensive care, days free of mechanical ventilation, development of acute organ failure during hospitalization and complications related to the treatment with the prone position.
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to a maximum of approximately 2 years.
The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19 subjects in need of oxygen treatment. The target was to include forty (40) subjects with diagnosed COVID-19 for participation in the study. If at screening all criteria for study participation were fulfilled and informed consent signed, the subject was enrolled and randomized into one of the two arms. After randomization, the subjects were to receive KAND567 or placebo treatment for 7 days. After the treatment period the subjects returned to ordinary clinical follow-up, but a study follow-up visit was to be planned for Day 21 and 90.
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19). The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.
The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.
Respiratory tract infections, e.g. caused by SARS-CoV-2, disproportionately affect elderly. Vaccination has shown to be the most cost-effective approach to prevent infections. However, older adults often fail to induce a potent immune response to vaccines, as was also seen recently for COVID-19 mRNA vaccines. This is likely due to immune dysfunction as a consequence of aging. To potentiate a stronger immune response, vaccine administration into the papillary dermis (intradermal, ID) has been proposed as an alternative strategy to intramuscular (IM) administration. Vaccination through the ID route has shown to be safe and equally or more effective than IM vaccination with a wide variety of vaccines. Recently, ID administration has been tested with two COVID-19 mRNA vaccines (Spikevax, Moderna and Comirnaty, Pfizer/BioNTech) in reduced (fractional) doses of the standard IM dose. To ease ID administration and thereby facilitate the implementation of this route, silicon-based microneedles have been developed. These needles have shown to allow ID administration of the Spikevax vaccine with equal safety and immunogenicity profiles as the traditional Mantoux approach in young adults. In the present study, we will investigate the immunogenicity of a 20 mcg dose of the COVID-19 mRNA Comirnaty vaccine through ID administration with silicon microneedles in elderly people (75 years and older), and compare this to immunogenicity of IM administration of a 20 mcg dose and a 30 mcg (standard IM) dose.
This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.
Phase 1b, randomized, open-label, study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 only, RVM-V002 only, or RVM V001 + RVM V002 (Co administered as Separate Injections) in healthy adults. The study will be conducted at one site in Singapore.
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6.
The purpose of this study is to evaluate the accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.