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 220 of 228Hospital de Clinicas de Porto Alegre
A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
Duke University
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation
Yale University
The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level COVID-19 seroconversion. The individual experiment assess whether masks protect against COVID-19 seroconversion. It also assesses the efficacy of high-quality cloth vs. surgical masks.
BRAC University
In line with BRAC's overall goals to limit the COVID19 transmission, BRAC has constructed 1,000 handwashing stations coupled with other supports i.e. in-person demonstration, hygiene meetings, and soap distribution in Bangladesh. The purpose of this study is to assess the impact of public handwashing stations (HWSs) on people's hygiene behavior and health outcomes in response to the COVID-19 situation. For this, at the household level, we will collect information on self-reported handwashing practices, income, health status, and HWSs along with other relevant socio-demographic variables in detail. In addition, we will observe people's mobility, mask usage at public places, and the HWSs usage; and will associate the observed HWSs usage with their self-reported health outcomes. This study will conduct surveys on households (7,760) and public (5,820) in 20 sub-districts of Mymensingh, Khulna, and Dhaka divisions. Overall, this study is expected to directly benefit study participants and their communities by unveiling new evidence to inform BRAC's existing hygiene behavioral change programming in these communities. In addition, this information will yield future societal benefits by generating evidence on how to effectively implement and disseminate infrastructure and information that people can trust, believe, and use to form healthy hygiene habits.
ARCTEC
Dogs are some of nature's greatest detectives, owing to their incredible sense of smell and ability to be trained. Most of us will be familiar with seeing trained sniffer dogs at airports looking for drugs and other prohibited items, but their skills don't stop there. The use of medical detection dogs is becoming increasingly common, as they are able to identify cancers, changes in blood sugar levels and even predict seizures. These are just a few examples of dogs playing a key role in public health. Many diseases can alter the way humans smell. A study undertaken by the London School of Hygiene & Tropical Medicine (LSHTM) and Durham University has shown that dogs are able to accurately diagnose malaria. The investigators know that respiratory illnesses can alter your body odours, and thus the investigators plan to determine whether dogs are able to identify the novel coronavirus known as COVID-19 (or SARS-CoV-2). COVID-19 can present itself asymptomatically (i.e. causing no apparent symptoms), which could lead to the spread of infection in the population. The investigators believe that dogs may be able to identify asymptomatic patients, as well as those who have mild symptoms (symptoms not requiring treatment, hospital stay or limiting normal activities). It is thought that a single medical detection dog stationed within an airport would be able to screen up to 750 people for COVID-19 infection in just 1 hour, informing those who are infected to isolate, preventing further spread of the disease. In order to determine whether it is possible for dogs to accurately diagnose COVID-19, the investigators must first collect samples. NHS staff and members of their households that are eligible for SARS-CoV-2 screening, have been selected to participate in this study due to their potential exposure to this disease agent. In addition, participants from the general population who are displaying mild COVID-19 symptoms or have been exposed to COVID-19 will be recruited via hospitals, testing centers, outbreak testing programs and home testing programs. Initially, participants will attend their screening test as planned or confirm that they have had a swab test within the previous 24 hours. Immediately following this, the investigators will ask participants to collect samples of breath odour and body odour, which will be collected passively through the wearing of face masks, shirts, and nylon socks. The investigators will ask to be provided with the results of the SARS-CoV-2 screening swab, which will allow for us to determine whether participants are positive or negative for SARS-CoV-2. These odour samples will be grouped by positive or negative test results, and transported to LSHTM where these will be processed in order to prevent contact with the virus, negating the risk for dogs and their handlers. A pilot study will be undertaken to confirm whether dogs are able to distinguish between positive and negative samples using traditional sniffer dog training methods. If this is possible, the investigators will proceed to the main study to determine the accuracy (known as sensitivity and specificity) of the dogs' ability to identify the virus. Both the handler and the dogs themselves will be 'blinded' to the samples, and thus unaware of which sample is which. When the data generated by these tests is entered, it will be confirmed whether or not the samples have been correctly identified. The dogs will be trained to detect and report the detection of the volatile odours characteristic of COVID-19 infection. For quality control purposes the investigators also aim to characterise the COVID-19 odour profile by analysing samples with a special process called GC (gas chromatography) and/or GC-MS (gas chromatography coupled mass spectrometry). This will help to inform the identification of compounds showing differences between infected and non-infected samples. The investigators believe that this work could be useful in the fight against COVID-19.
University of Pennsylvania
In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. This study will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing.
Blackstone Valley Community Health Care
Lifespan Cancer Institute serves over 50% of cancer patients in the state. Rhode Island is known for strong medical care and high rates of cancer screening with mammography and colonoscopy. However, cancer screening has plummeted during the COVID-19 pandemic, in part to closing physician offices and stopping non-urgent medical procedures. In addition, anecdotal reports suggest the public remains concerned about returning to physician's offices and risking possible exposure to COVID-19. As in the United States as a whole, COVID-19 has disproportionately impacted ethnic and minority individuals within underserved communities; and in Rhode Island, African Americans, Hispanics and undocumented individuals living in communities such as Central Falls, Pawtucket, Providence, East Providence and North Providence have had the highest rate of COVID-19. These communities are also impacted by healthcare disparities to access and affordability of healthcare, and as such, may be among the least likely to resume cancer screening. The Lifespan Cancer Institute will institute a project to address health disparities in cancer screening during the pandemic through the use of a targeted campaign involving social media. The goals will be to re-establish screening in the era of COVID-19 and ensure timeliness of care for those found to be at risk, or are positive for, cancer.
UKK Institute
This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care. Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction. Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.
Tanta University
The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.
Assistance Publique - Hôpitaux de Paris
The purpose of this case-control study is to assess the association of the current and former consumption of tobacco and nicotine in the risk of acquisition of severe acute respiratory syndrome 2 (SARS-CoV-2). the investigators will send a structured interview by mail regarding use of tobacco and nicotine to 2500 healthcare workers (1250 cases with a positive Real Time Polymorphism Chain Reaction (RT-PCR) and 1250 controls with a negative PCR) who were tested in Paris for in March and April, 2020. OR will be estimated by conditional logistic regression modelling with matching for sex and age.