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 1460 of 1505Northwestern University
This is a single-blind study consisting of up to 3 cohorts Patients will be randomized 3:1 to Auxora or Placebo. The first 4 patients will be enrolled in Cohort 1. If dose escalation occurs, the next 4 patients will be enrolled in Cohort 2 If dose escalation occurs, the next 8 patients will be enrolled in Cohort 3. The decision to escalate dosing will be made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.
National Institute of Mental Health (NIMH)
In the current study, the investigators will revise our existing 10-session group RRT treatment manual to specifically address the challenges in building social support and enhancing both momentary and sustained reward during the COVID-19 pandemic (Preliminary Aim 1). In months 2-18, the investigators will conduct a small pilot RCT that will randomize individuals to receive either 10-sessions of RRT (n=30) or supportive therapy (n=30), both delivered as group-treatments via videoconferencing software. The specific aims of the current study are to confirm the feasibility and acceptability of RRT for EDs (Primary Aim 1), evaluate the ability of RRT to engage critical targets including reward to day-to-day life activities, reward to palatable foods, social isolation, and loneliness (Primary Aim 2), and provide preliminary estimates of efficacy in reducing ED symptoms at both post-treatment and a 3-month follow-up (Primary Aim 3). the investigators will also evaluate the impact of RRT on secondary outcome variables including depression, substance use, and quality of life (Secondary Aim 1).
Postgraduate Institute of Medical Education and Research
A proportion of patients with COVID-19 pneumonia have a prolonged course of illness. Some of these patients continue to have considerable respiratory symptoms or persistent hypoxemia. The CT abnormalities in these patients are often a combination of ground-glass opacities and patchy multifocal consolidation consistent with a pattern of OP. In several patients, these radiologic abnormalities persist. As with other forms of OP, patients with post-COVID OP or post COVID diffuse lung disease (PC-DLD) may benefit from treatment with oral glucocorticoids. The ideal dose of glucocorticoids for treating PC-DLD is unknown. In this study, the investigatros aim to compare the efficacy and safety of a medium dose and a low dose of prednisolone (as the initial dose) for the treatment of post-COVID. diffuse lung disease.
Colorado Prevention Center
Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.
Daniel Griffin
This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.
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.
Aventyn, Inc.
Researchers are creating real-time epidemiology registry to evaluate the efficacy of COVID-19 subject risk assessment scores based on recording of symptoms, biomarkers, chronic illness and mental health assessments with digital technology using wearables and mobile app tools. Researchers aim to study in Phase 1, epidemiological variations in COVID-19 presentation in both PCR positive and negative subjects in the registry. Assessment of variables, predictive modeling of variables that impact severity of COVID-19 positive and negative subjects and assessment of predictors for post COVID-19 complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied in the intervention group comparing ECL-19 vs placebo with primary end point of hospital admission assessment. Treatment strategy for PCR positive COVID-19 subjects in the registry who are in Stage I of the disease process with ECL-19 drug compared to placebo in reducing hospital admissions
University of Ottawa
In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.
Pregistry
The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
A. Vogel AG
Respiratory viruses pose a permanent threat to humans and society as demonstrated by the current Covid-19 pandemic. Novel drugs and vaccines provide a means for controlling illness. Infections and symptomatic presentation of illness may be reduced, but it remains to be determined to which extent viral shedding and transmission (e.g. by silent transmitters) can be controlled. Lack of such activity may result in continuing viral spread by assumed healthy but asymptomatic spreaders. Echinacea is an established and readily-accessible product with demonstrated in vitro antiviral activity (including coronaviruses). This study aims to estimate the potential of different Echinacea formulations (head-to-head) to reduce concentration infectivity and shedding of SARS-CoV-2 under in vivo conditions.