Kota

Researchers are evaluating the safety and effectiveness of centhaquine citrate (LYFAQUIN193), a new drug designed to treat hypovolemic shock, which is a serious condition caused by severe blood or fluid loss. This phase IV, open-label, multi-center study involves adult patients aged 18 years or older who are experiencing hypovolemic shock with low blood pressure and elevated blood lactate levels. Centhaquine has shown promising results in animal models by improving blood pressure, cardiac output, and reducing mortality through its action on specific adrenergic receptors. Participants will receive centhaquine alongside standard shock treatments such as fluid resuscitation, vasopressors, and endotracheal intubation. The drug will be given intravenously at a dose of 0.01 mg/kg in 100 mL of normal saline over one hour. If blood pressure remains low, an additional dose may be given after 4 hours, with a maximum of three doses within 24 hours. Centhaquine administration can continue for up to two days after enrollment, with close monitoring throughout their hospital stay. During the study, patients will be monitored until discharge or for up to seven days from enrollment. Researchers will assess safety by tracking adverse and serious adverse events, as well as efficacy by measuring blood pressure, lactate levels, base deficit, and survival rates. Statistical analyses will compare patient outcomes, and the results will be presented with detailed data summaries to evaluate the drug's safety and benefits when added to standard care for hypovolemic shock.

Researchers are evaluating the safety and effectiveness of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for acute cerebral ischemic stroke. This prospective, multicenter, randomized, double-blind, parallel phase IV study focuses on patients who have experienced a stroke caused by a blockage in the brain's blood flow. The study explores how sovateltide may support brain repair by activating neuronal progenitor cells, promoting new blood vessel growth, preventing cell death, and increasing cerebral blood flow after ischemia. Participants will be divided into two groups of 80 patients each. One group will receive intravenous sovateltide alongside standard stroke treatment, while the other group will receive normal saline with standard treatment. Sovateltide or saline will be administered in three doses as IV boluses on day 1, day 3, and day 6, with doses spaced about three hours apart on day 1. The entire study will last about 18 months, including approximately 15 months for patient enrollment. During the 3-month follow-up period, each participant will attend three study visits. Researchers will monitor safety by tracking adverse and serious adverse events and assessing laboratory tests, vital signs, and physical exams. Effectiveness will be evaluated using stroke-related scales such as the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index. All participants or their representatives will provide informed consent, and statistical analyses will compare outcomes between the treatment and control groups.