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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Displaying 340 of 488Brigham and Women's Hospital
Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
This is a randomized, double-blind, placebo-controlled, multi-arm, multicenter, phase II trial design to allow a rapid efficacy and toxicity assessment of potential therapies (camostat mesilate and artemisia annua) immediately after COVID-19 positive testing in mild to moderate disease and high-risk factors such as diabetes, hypertension, and obesity among others.
Dr. Reddy's Laboratories Limited
This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19. This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.
ClinAmygate
Time to recover of Anosmia and / or ageusia and early corticosteroid use
Hospital Nacional Arzobispo Loayza
Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection. Participants will be randomized to receive daily bovine lactoferrin plus standard measures during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target enrollment is 336 participants. Each study participant will be monitored twice a week for symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.
NYU Langone Health
COVID-19 is associated with acute pulmonary and cardiac injury. To better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of COVID-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of COVID-19.
Nature Cell Co. Ltd.
This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Viela Bio
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
Karolinska Institutet
In a cohort study, the investigators aim to compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.
Sanofi
Primary Objective: •To assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in the NSQ NSCLC population Secondary Objectives: - To assess the safety and tolerability of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed - To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy, with or without pemetrexed in the NSQ NSCLC population - To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed) - To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed