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2,385 active trials for COVID-19

Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults

This is a multicenter, US-only, phase 1, open-label, dose escalation, non-randomized study of homologous and heterologous prime-boost vaccination schedules to examine safety, tolerability, and immunogenicity of investigational Chimpanzee Adenovirus serotype 68 (ChAd) and self-amplifying mRNA (SAM) vectors expressing either Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike alone, or spike plus additional SARS-CoV-2 T cell epitopes (TCE) in healthy adult subjects. Stage 1 will compare ChAd and SAM vaccines encoding only the spike protein in a 2-group dose escalation trial in subjects 18-60 years old, and a 3-group dose escalation trial in subjects over 60 years old, focusing on heterologous ChAd prime/SAM boost and homologous SAM prime/SAM boost regimens including sentinels, and staggered enrollment for dose escalation. Stage 2 will compare optimal doses of ChAd and SAM vaccines (determined in Stage 1) encoding both spike and TCE, in subjects 18 years and older enrolled into up to 6 groups simultaneously to receive homologous SAM prime/SAM boost, homologous ChAd prime/ChAd boost and heterologous ChAd prime/SAM boost combinations. Up to 70 (Stage 1) and up to 70 (Stage 2) males and non-pregnant females >/= 18 years of age who are in good health, do not have high risks for SARS-CoV-2 infection or for severe Coronavirus Disease 2019 (COVID-19) disease progression, and meet all eligibility criteria will be enrolled. Subjects will be enrolled at one of at least 4 distinct US-based Infectious Diseases Clinical Research Consortium (IDCRC) sites into different groups based on their age (18-60 and >60 years old). The primary objective of this study is to assess the safety and tolerability of different doses of ChAd-S (or ChAd-S-TCE) and SAM-S (or SAM-S-TCE) when administered as prime and/or boost in healthy adult subjects including older adult subjects.

Start: March 2021
A Study of Micro Dose Ambrisentan in Hospitalized Patients With Respiratory Insufficiency Due to COVID-19

Patients with COVID-19 frequently develop lower respiratory complications. Difficulty breathing and a low concentration of oxygen in the blood are of concern in patients with COVID-19, as they indicate that the lungs may be significantly affected. In some patients, respiratory symptoms may progress to the point where oxygen support is needed (i.e. use of an oxygen prongs, mask or ventilator). The exact mechanism of why patients with COVID-19 develop low concentrations of oxygen in blood is not fully understood. Some data suggest that the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus causing Coronavirus Disease 2019 (COVID-19), can affect the body's blood vessels directly and extensively. In the lung, blood vessels participate in the absorption of oxygen. Endothelin is a potent hormone produced by human blood vessels. When increased, endothelin can result in the narrowing of blood vessels in the lung and decrease the volume of blood flowing through the lungs. This decrease in in blood flow through the lungs may be one of many factors affecting normal lung function. Ambrisentan can block the effects of endothelin in the body, and this could theoretically improve blood flow through the lungs. This study will evaluate whether ambrisentan, by blocking the effects of the hormone endothelin in the lungs, improves the breathing capacity of patients with COVID-19, increases the concentration of oxygen in the blood and prevents the progression to respiratory failure and death. Ambrisentan is a drug that is currently used to treat patients with pulmonary hypertension, a disease where blood flow through the lungs is decreased. Subjects participating in this study are those patients hospitalised with severe respiratory symptoms related to COVID-19, and are considered to be at high-risk of developing respiratory complications. Ambrisentan will be administered in the hospital, and will be continued at home for up to 28 days. In this study, ambrisentan will be administered at much lower doses that those used in patients with pulmonary hypertension.

Start: February 2021