COVID-19 Clinical Trials and Expanded Access

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.

With the results of this study the investigators aim to identify an effective treatmentthat will reduce morbidity and mortality of patients with symptomatic COVID-19 infection,which would in turn reduce the burden on the healthcare system by decreasing the need forintensive care.Objectives: The main objective of this research is to determine if once weekly treatmentwith the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiaccomplications of COVID-19 infection.Study Plan: The study design is prospective randomized open-label blinded-evaluation(PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced riskprofile as described above, who have been admitted to hospital due to symptoms ofCOVID-19 infection but do not as yet require critical care will be approached toparticipate in this study. Provided there are no exclusion criteria and the participantsagree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately afterrandomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn atDay 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG willbe obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28.Primary outcome measure: A composite of (1) death from any cause or (2) mechanicalventilation (invasive or non-invasive) at 28 days.Major secondary outcome measure:(1) an elevation to >99th percentile URL upper reference limit (URL) in those with abaseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline inthose with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days)post randomization.Other major secondary outcome measure:A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economicand mental-health challenges, especially for vulnerable populations such as pregnant andpost-partum females. In this study, we aimed to evaluate the relations between the fearof COVID-19 and postnatal depression symptoms.

Study population: Patients with fibrotic lung sequelae after recovery from acute phase ofsevere COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administeredfor 24 weeks in patients who have pulmonary fibrotic changes after suffering severeCOVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung

Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinicalsymptoms including dyspnea, cough and fever, hospitalized in the KETER department inseveral hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml-control arm .Treatment duration: 14 days or until clinical improvement that enables discharge fromhospital.(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days.14-30 days after discharge from hospital: we will contact the patient via phone to askquestions related to any possible adverse reaction to the drug and general health.

This is an observational COVID-19 study that uses wearable health monitoring technologyto follow COVID-19 positive individuals to monitor persistent symptoms and any potentiallong-term complications or cardiovascular and behavioral impacts from the disease.

COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic byspreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-likeillness with expected recovery. According to World Health Organization, the overallglobal case fatality rate is currently estimated to be 2.9%. However, patients havingsevere or critical illness presenting with severe respiratory distress, ARDS or shocksuffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild orsevere cytokine storms in severe patients, which is an important cause of death. Anexaggerated and uncontrolled release of pro-inflammatory mediators by an overly activatedimmune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) whichhas an important role in the hemodynamic insults seen in very ill COVID-19 patients. Thisaberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acutekidney injury, etc. In this study, the investigators aim to estimate the burden ofcytokines and their correlation with the magnitude of the severity of COVID-19 illness inBangladeshi adults.

The aims of this study are to assess whether the use of a MBI therapy delivered remotelyis associated with a reduction of perceived stress among HCPs in the Radiation MedicineProgram (RMP) and with a decrease risk of burnout during and post COVID-19.

The principal objective is to determine the impact of phenelzine on the activationphenotype of T cells and myeloid cells during SARS-CoV2 infection

The COVID-RASi study is an international randomized clinical trial that will evaluate thepotential benefit of angiotensin modulators on clinical outcomes, in COVID-19 patients.The purpose of this study is to determine if renin-angiotensin system inhibitors (RASi),with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers(ARB), has a beneficial effect in patients with COVID-19 infections, by reducing ICUadmission, ventilator requirement or death. We would also like to determine if there aredifferences between ACEi and ARB therapeutic treatments. With the increasing potential oflong COVID symptoms, at the 1 year follow up, a primary endpoint will be the quality oflife of study participants, as assessed by ongoing symptoms and/or the standardizedquestionnaires.