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 550 of 964National Institute of Environmental Health Sciences (NIEHS)
Background: Inequalities in COVID-19 infection, hospitalization, and death in under-studied, under-represented, and under-reported groups of people are severe. A growing number of studies have assessed the impact of individual risk factors. But few studies have assessed which factors are the greatest drivers of COVID-19 disparities from a wider perspective. Objective: To understand the long-term impacts of COVID-19 on minority women and their families to assist in developing community-based programs to help in recovery. Eligibility: Healthy people aged 18 and older who reside in North Carolina. Design: Participants will take a 45-minute online survey. The survey will cover their demographics, community, health, lifestyle, household, and environment. Participants may choose to have tests. They may visit the Clinical Research Unit. They may also have a home visit for these tests. In some cases, they may mail samples to the study team in prepaid envelopes. Participants may take an optional 15 minute survey about their reproductive history. Participants may give a blood sample. Participants may give urine samples. They will be asked to give 4 samples on 2 consecutive days. They will fill out a log with each sample they collect. Participants may give saliva samples. Participants will give toenail samples from each toe. Participants will give dust samples. They will be given 8 alcohol swabs. Two will be for testing. They will be asked to swipe a total of 3 door frames. Each door frame should be in a different room of the house. Participants will be given silicone wristbands to wear for 1 week. This is to measure their exposure to air pollutants. Participants may be contacted in the future for follow-up. They may be contacted by phone, email, or letter.
Jesús R. Requena
The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA, hard caplets containing cryogenized root of the plant Echinacea purpurea, show an improvement of the clinical manifestations and disease course in ambulatory patients with covid-19 with a respiratory presentation and not requiring hospitalization (i.e., mild covid-19). The drug being evaluated will be added as a supplement of the standard treatment, with its current recommended dose for treatment of the common cold. 2) Safety: to determine that the incidence of adverse events is not higher than that seen with the standard treatment applied in each case.
Ivan S Moiseev
This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.
University of Geneva, Switzerland
The XPHI-COVID-2 randomized study aims to investigate the moral choices in a context of scarce resources. The participants are asked to complete the questionnaire of the Oxford Utilitarianism Scale and are exposed to medical triage dilemmas. Participants are randomized between a group with reading of ethical guidelines and a group without reading of ethical guidelines, before they are asked to complete the questionnaire and being exposed to triage dilemmas.
Weill Medical College of Cornell University
Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD. A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity. Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area. The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.
Clinical Urology and Epidemiology Working Group
SOLIDARITY Finland Long-COVID trial assesses the effects of remdesivir + standard of care (SoC) vs. only SoC on long-COVID symptoms and quality of life (QoL) using questionnaires at one and two years post-discharge. Objectives i) Long-COVID symptoms - To investigate the effect of remdesivir (vs. SoC) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place 1 and 2 years after the hospital admission. - The symptom questionnaire - that will be completed by patients at one and two years - measures basic patient information (age, height, weight, smoking status, major comorbidity, and working status) and a wide variety of potential long-COVID-symptoms and their bother (1. Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping difficulties; 5. Depressive mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus; 10. Paresthesias; 11. Changes in taste/smell perceptions; 12. Postexertional malaise; 13. Palpitations; 14. Chest discomfort; 15. Nausea; 16. Skin rash; 17. Joint aches; 18. Muscle pains; 19. Continuous cough; 20. Respiratory tract mucous discharges) in remdesivir and usual care arms ii) Quality of life - EQ-VAS: to compare patients' quality of life in remdesivir and usual care arms. - EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3. Usual activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The VAS of subjective perception of overall health. Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions; currently the study has ethical approval for long-COVID and quality of life assessments only): - The Finnish healthcare registries (Statistics Finland Mortality Database and the HILMO Care Register for Health Care) will be used to estimate long-term mortality and incidence of major comorbidity in remdesivir and usual care arms - Lung function will be assessed using spirometry and diffusing capacity, as well as the six-minute walk test (6 mwt) in remdesivir and usual care arms - Whole-genome genotyping will be performed for a genome-wide association study to investigate genetic correlates of long-COVID-19 -symptoms in remdesivir and usual care arms UPDATE 02.02.2022: Primary outcomes will comprise the following: 1. EQ-VAS 2. EQ-5D-5L, summary 3. Does the patient feel recovered from COVID-19-infection at one year or not? (question no. 10) 4. Fatigue (questionnaire, question no. 14) 5. Exertional dyspnea (question no. 12)
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
The increased risk of transmission of COVID-19 infection causes the incidence of death in health workers to escalate. It requires further research on risk factors and intervention in health worker professionals, especially on immunity factors and nutritional status. Quality of diet and nutrition is very important to support the immune system when infected. Several probiotic strains have been shown to decrease the duration and incidence of diarrhea and respiratory infections, suggesting the Gut-Lung Axis pathway. Some probiotics also improve the balance of diversity in the composition of the gut microbiota and affect body weight in obese people. Probiotics have also been shown to improve vitamin D absorption. A combination of vitamin D and probiotics may be an alternative to reduce gut dysbiosis that will directly or indirectly reduce the risk and severity of viral infections including SARS-CoV-2.
GeoVax, Inc.
This phase II trial studies the immune response to COH04S1 compared to Emergency Use Authorization (EUA) SARS-COV-2 vaccine in patients with blood cancer who have received stem cell transplant or cellular therapy. COH04S1 belongs to a category called modified vaccinia Ankara (MVA) vaccines, created from a new version of MVA, called synthetic MVA. COH04S1 works by inducing immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The immune system is stimulated to produce antibodies against SARS-CoV-2 that would block the virus from entering healthy cells. The immune system also grows new disease fighting T cells that can recognize and destroy infected cells. Giving COH04S1 after cellular therapy may work better in reducing the chances of contracting coronavirus disease 2019 (COVID-19) or developing a severe form of COVID-19 disease in patients with blood cancer compared to EUA SARS-CoV-2 vaccine.
Karolinska University Hospital
Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients who have been in hospital for Covid-19 for a long time may need specialized rehabilitation, however, also non-hospitalized patients with mild symptoms may need specific rehabilitation to be able to meet the complex symptoms and problems that may arise. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions so that these patients receive appropriate rehabilitation The aim of this study is to evaluate the effects of inspiratory muscle training on adult patients with PACS and decreased respiratory muscle strength. A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80 % or less of predicted value in inspiratory muscle strength (maximal inspiratory pressure) will be eligible for enrollment. Patients will be randomized either to an intervention group or a control group. The intervention will consist of inspiratory muscle training performed twice daily for 8 weeks. This will be combined with an 8-week physical exercise training program. The control group will perform the same physical exercise training according to standard care. All measurements will be performed at baseline and after 8 weeks. Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximal expiratory pressure, pulmonary function, physical capacity, physical activity, respiratory status and symptoms, health-related quality of life, work ability, fatigue, self-reported outcome measure of physical function and voice function. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways and lead to a negative impact on quality of life in the long-term perspective. Therefore, development of a rehabilitation program with specific tailored interventions will be necessary to improve physical and psychological function, as well as health-related quality of life and work ability.
Centre Hospitalier Universitaire de Nīmes
The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.