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Infusion Treatment Using Bone Marrow Mesenchymal Stem Cell (bmMSC) Derived Extracellular Vesicle Product, ExoFlo™, for COVID-19 Associated ARDS (EXIT COVID-19), is currently being studied in Protocol DB-EF-PhaseII-001 in patients with COVID-19 associated moderate to severe Acute Respiratory Distress Syndrome (ARDS). This expanded access protocol is an open-label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase II randomized controlled trial because they: - Do not meet phase II eligibility criteria at current phase II sites. - Do meet phase II eligibility criteria but cannot access phase II sites. - Do not meet phase II eligibility criteria & cannot access phase II sites. •
This expanded access protocol will provide access to the investigational product ZofinTM (OrganicellTM Flow) for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.
This expanded access use program will provide a botanical drug of T89 for treatment use in an intermediate-size population infected with SARS-CoV-2 who have severe COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening condition.
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
Provide Compassionate Use access to REGN-COV2 for adult patients with recently diagnosed mild-to-moderate coronavirus disease (COVID-19) who are at high risk for poor outcomes.
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization. Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.