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 380 of 399Luxembourg Institute of Health
Predi-COVID is a prospective cohort study composed of people positively tested for COVID-19 in Luxembourg, followed digitally for monitoring participants' health evolution and symptoms at home. Participants will be actively followed for 14 days from the time of confirmation of diagnosis, whether they are at the hospital or at home in isolation or quarantine. Short evaluations will be also performed at week 3 and week 4 and then monthly for a period up to 12 months to assess potential long term consequences of COVID-19. A subsample of 200 participants will be contacted to integrate complementary clinical data and collect samples. The study aims at identifying factors associated with the COVID-19 disease severity. COVID-19 patients with severity criteria will be compared to patients with mild disease managed at home. A deep phenotyping related to the symptoms of the disease as well as biosampling allowing for laboratory-based and computational analytics will be performed.
Centre Hospitalier Intercommunal Creteil
In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic. As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown. This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.
PENTA Foundation
Scientific knowledge about the COVID-19 pandemic and the virus that is causing it (SARS-CoV-2) is developing rapidly, and the investigators have a clearer idea of the population groups who are at higher risk of becoming infected, having serious illness, and dying. However, less is known about COVID-19 in children, adolescents and young adults living with HIV. It is not yet known whether, or how, HIV affects people's risk of being infected with the virus or becoming ill. This study aims to find out whether children and adolescents living with HIV have had the COVID-19 virus, even if they did not have symptoms and did not realise it at the time. When a person is infected with a virus, their immune system fights the infection. As a result, they produce proteins called antibodies, and it may take a few weeks for enough antibodies to be made to be detected by a blood test. These antibodies may help protect the person from getting the same infection again. This study wants to find out how many children and adolescents living with HIV across Europe and South Africa have antibodies to the COVID-19 virus. It wants to see if the proportion with antibodies is different in younger children compared to older adolescents and young adults, and whether it varies between different countries. Children and adolescents with HIV regularly attend hospital outpatient appointments, and during these appointments blood samples may be taken to monitor their health. This study will invite these patients to be tested for antibodies to the COVID-19 virus during their routine visit. The participants will be asked a few short questions about COVID-19 diagnoses in their household and other risk factors for exposure to the virus, and it will collect information on their HIV, medications and any other illnesses they may have. At their next routine clinic visit, approximately 6 months later, it will test them again for antibodies. Testing twice will let see how the percentage of children, adolescents and young adults with antibodies to the COVID-19 virus has changed over time. In South Africa, HIV-uninfected adolescents from a similar socioeconomic background to those living with HIV and recruited to the study will be invited to join this study, which will allow us to compare the prevalence of antibodies across the two groups. The information from this study will help scientists and healthcare workers care for children, adolescents and young adults living with HIV during the ongoing COVID-19 epidemic in the best possible way. Participants may be given their test results, together with information about what the result means, depending on the usual practice within their clinic.
Assistance Publique - Hôpitaux de Paris
The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.
Nanowear Inc.
The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to Covid-19.
University of California, San Francisco
There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.
Haukeland University Hospital
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.
Pregistry
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine. Specifically, the C-VIPER will estimate the risk of obstetric outcomes (spontaneous abortion, antenatal bleeding, gestational diabetes, gestational hypertension, intrauterine growth restriction, postpartum hemorrhage, fetal distress, uterine rupture, placenta previa, chorioamnionitis, Caesarean delivery, COVID-19), neonatal outcomes (major congenital malformations, low birth weight, neonatal death, neonatal encephalopathy, neonatal infections, neonatal acute kidney injury, preterm birth, respiratory distress in the newborn, small for gestational age, stillbirth, COVID-19), and infant outcomes (developmental milestones [motor, cognitive, language, social-emotional, and mental health skills], height, weight, failure to thrive, medical conditions during the first 12 months of life, COVID-19) among pregnant women exposed to single (homologous) or mixed (heterologous) COVID-19 vaccine brand series from 30 days prior to the first day of the last menstrual period to end of pregnancy and their offspring relative to a matched reference group who received no COVID-19 vaccines during pregnancy.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Background: Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. Objective: To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases. Eligibility: People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer Design: Participants will have a screening visit. This will include: Medical history and physical exam EKG Chest x-ray COVID-19 test. A swab will be put in the participant s nose or the back of their mouth. Blood and urine tests Participants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infection Depending on their group, participants will have 1 to 5 more visits. These will occur over 12 to 18 months. Visits may include: FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine creates pictures of the body. For the scan, they will have a radioactive substance injected into their arm through an IV. Kidney function tests Non-invasive vascular studies test. These tests are similar to what it feels like to have blood pressure checked.
Corporacion Parc Tauli
The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.