Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov. If you do not find a satisfactory expanded access program here, please search in our COVID Company Directory. Some companies consider expanded access requests for single patients, even if they do not show an active expanded access listing in this database. Please contact the company directly to explore the possibility of expanded access.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
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To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 6 of 6Mesoblast International Sàrl
The objectives of this intermediate-size expanded access protocol are to assess thesafety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
ZEO ScientifiX, Inc.
This expanded access protocol will provide access to the investigational product Zofinfor patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderateCOVID-19, or who are judged by a healthcare provider to be at high risk of progression tomoderate disease.
Genentech, Inc.
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV)and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring the COVID-19 pandemic.This study will enroll approximately 200 patients in the United States.Participants with early or metastatic HER2+ breast cancer will be enrolled in this study.Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary due to disease recurrence, disease progression, unacceptable toxicity,participant withdrawal of consent, or per physician's recommendation.A remote cardiac surveillance substudy will be optional for patients enrolled at selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.
Gilead Sciences
The primary objective of this study is to provide expanded access of remdesivir (RDV) forthe treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
Mayo Clinic
This expanded access program will provide access to investigational convalescent plasmafor patients in acute care facilities infected with SARS-CoV-2 who have severe orlife-threatening COVID-19, or who are judged by a healthcare provider to be at high riskof progression to severe or life-threatening disease.
Hudson Medical
Covid-19 has spread rapidly throughout the world causing widespread panic, death, andinjury. While this virus is the provocateur, it is often the patient's owndisproportionate immune response which deals the most devastating (and often fatal)damage. A specific part of the immune system, known as the complement, has been shown tocause such damage in other types of coronaviruses. In the SOLID-C19 study, Soliris(Eculizumab) will be used to modulate the activity of the distal complement preventingthe formation of the membrane attack complex. By modulating this portion of the immuneresponse, mortality can be halted while the patient has time to recover from the viruswith supportive medical care.