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.
Search Tips
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 270 of 727Johns Hopkins University
Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in animal models and several human trials. In addition to cellular replacement through regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute cardiac injury. There is presently no cure for the COVID-19 viral disease; however, multi-treatment strategies are being examined. During the past two months, four reports were published that suggest, mesenchymal stem cells (MSCs), owing to their powerful immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy. These reports, taken together with the previous successes of stem cell therapy in animal models, the investigators, a seven-institution consortium, propose to explore the efficacy of UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on days 1, 3, and 5. The second group of five patients serving as control will only receive standard treatment. During the 30-day post-infusion period, a battery of tests will be performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the investigators propose a comparative study to determine COVID-19 viral count by quantitative real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally developing a rapid diagnostic assay.
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.
University Health Network, Toronto
Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness. Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.
Shanghai Junshi Bioscience Co., Ltd.
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)
William Beaumont Hospitals
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. - Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator - Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the participant is in the hospital The participant's final health status will be determined on day 28. Hospital records will be monitored for 90 days after discharge to determine if the participant is readmitted to the hospital.
Instituto Grifols, S.A.
The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.
Centro Medico ABC
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
Yale University
In times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery. The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.
University of Oxford
A Phase I/II, double-blinded, placebo-controlled, individually randomized trial to assess safety, immunogenicity and efficacy of the candidate Coronavirus disease (COVID-19) vaccine ChAdOx1 nCoV-19 in adults aged 18-65 years living with and without HIV in South Africa. The vaccine or placebo will be administered via an intramuscular injection into the deltoid muscle of the non-dominant arm.
Instituto Nacional de Enfermedades Respiratorias
This study will explore whether a daily supplement of glycine, a substance that has antiinflammatory, cytoprotective, and endothelium-protecting effects, can improve mortality, as well as clinical and biochemical parameters, in patients with severe COVID-19 who initiate mechanical ventilatory support.