Novel treatment of cardiopulmonary failure in covid-19

Purpose and goal Covid-19-patients in ICU often has pulmonary hypertension with the risk of heart failure and death. Nitric oxide (NO) can effectively lower blood pressure in the lungs and prevent heart failure. Nitric oxide has an antiviral effect against the Sars CoV 2 virus. Supernitro (PDNO) is a new intravenous NO-donating drug candidate with a potent vasodilator effect in the lung. The Swedish MPA has recently approved a Phase 1 study of PDNO. The objective is to perform a clinical study of i.v. PDNO in covid-19 patients with imminent cardiopulmonary failure and to demonstrate clinical reversal. Expected results and effects The study is expected to show that intravenous PDNO can effectively lower high blood pressure in the lung and thus improve the heart´s pumping ability in intensive care Covid-19 patients, without affecting blood pressure in the rest of the body, so that blood flow to vital organs is maintained. PDNO safety (adverse reactions), dosage levels and possible antiviral effects will be studied in detail with data collection according to standardized protocol. Planned approach and implementation This is an open-label, multicenter study evaluating the effect, safety and tolerability of intravenous PDNO infusion given to COVID-19 patients with acute pulmonary hypertension. After approved consent twelve patients will be studied. In compliance with international standards, a recognized research organisation such as Clinical Trial Consultants, Uppsala, Sweden will manage the study following a Clinical Study Protocol approved by the Swedish Medicines Agency. There will be a Principal Investigator at each of four study sites. Örebro University Hospital (ÖUS) will lead.