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 20 of 190Tanta University
In December 2019, a new infectious respiratory disease emerged in Wuhan, Hubei province, China. An initial cluster of infections was linked to Huanan seafood market, potentially due to animal contact. Subsequently, human-to-human transmission occurred and the disease, now termed coronavirus disease 19 (COVID-19) rapidly spread within China and all over the world. A novel coronavirus, SARS-coronavirus 2 (SARS-CoV-2), which is closely related to SARS-CoV, was detected in patients and is believed to be the etiologic agent of the new lung disease. The causative agent of the current COVID-19 pandemic, SARS-CoV-2, is a single stranded positive sense RNA virus that is closely related to severe acute respiratory syndrome coronavirus (SARS-CoV).
St. Justine's Hospital
INTRODUCTION As there is no specific cure in the treatment of COVID-19 at this moment of the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation of high demand and potential staff shortage in ICU. Also, the investigators need to reduce unnecessary exposure of the providers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19. METHODS Objective: To explore if a NIOD performed by non-specialized personnel is not inferior to the standard Chest PhysioTherapy (CPT) in the care of COVID-19. Design: A Pilot Multicenter Prospective Crossover Randomized Study. Setting: Two ICUs in Canadian Academic Hospitals (CHU Sainte Justine and Montreal General Hospital) Patients: All the mechanically ventilated patients admitted to the two ICUs, and CPT ordered by the responsible physician, with COVID-19 infection during the study period. Procedure: The investigators will implement NIOD and CPT alternatingly for 3 hours apart over 3 hours. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, Intermittent Positive Pressure Ventilation (IPPV), suctioning (e.g., oral or nasal), or changing the ventilator settings or modality can be provided at the direction of bedside intensivists in charge. The order of the procedures (i.e. NIOD or CPT) will be randomly allocated. Measurements and Analyses: The primary outcome measure is the oxygenation level before and after the procedure (SpO2/FIO2 (SF) ratio). For the cases with Invasive ventilation and non-invasive ventilation, the investigators will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, desaturations, or unexpected extubations. The investigators will collect the data before, 10 minutes after, and 30 minutes after the procedure. Sample Size: The investigators estimate the necessary sample size as 25 for each arm (Total 50 cases), with a power of 0.90, alfa of 0.05, with the non-inferiority design. FUTURE CONSIDERATIONS This randomized pilot study will be considered a running phase if the investigators can/should undertake the RCT which should follow without significant modification of the methods.
Nantes University Hospital
The global pandemic of novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) began in Wuhan, China, in December 2019, and has since spread worldwide.1 As of April 14, 2020, there have been more than 1.5 million reported cases and 124 000 deaths in more than 200 countries. A recent open-label nonrandomized French study reporte that addition of azithromycin to hydroxychloroquine in 6 patients resulted in numerically superior viral clearance (6/6, 100%) compared with hydroxychloroquine monotherapy (8/14, 57%) or control (2/16, 12.5%). Azithromycin alone has never been tested, whereas azithromycin has immunomodulating and anti-inflammatory properties that could theoretically prevent or limit secondary worsening. Our hypothesis is that azithromycin combined with amoxicillin/clavulanate will be superior to amoxicillin/clavulanate alone to obtain viral clearance at Day 6 in COVID-19 patients with pneumonia and hospitalized in a non-intensive care unit ward.
Cairo University
This study will be concerned with managing patients of Covid-19 while being home isolated.
Max Healthcare Insititute Limited
1. To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India 2. To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India Hypothesis: There is likelihood of significant symptoms of depression and anxiety among general population in India during the current COVID-19 outbreak. Procedure: The participants would be selected with their informed consent. The objective of the study would be clearly written on Page 1 of the survey. The test would be administered electronically by all the participants individually only when consented to the study. The data collected will be kept strictly confidential and the identity of the participants will not be disclosed at any point of the research Measures: 1. Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level ofEducation, current living arrangement (e.g. staying alone or with family) and Occupation. It further includesregular employment status and current employment status(e.g, Work from home, temporary leave, termination etc) 2. History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness 3. COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includesinformation on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19. 4. Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by
China-Japan Friendship Hospital
The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City.
National Cancer Institute (NCI)
This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.
Hôpital Cochin
This study evaluates the effects of the addition of chlorpromazine to the standard therapeutic protocol in COVID-19 patients hospitalized for respiratory symptom management (score 3-5 WHO Ordinal Scale for Clinical Improvement).
University of Utah
Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.
University Ghent
Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). After the training, participants could better reinterpret negative photos in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. Moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). In the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. Given that the current COVID-19 pandemic is perceived as very stressful by a lot of people, the training could help here. Participants between 18 to 65 years of age are recruited during this corona crisis. The attention control training is a new smartphone based application. Participants have to unscramble scrambled sentences into grammatically correct sentences. In the training condition, participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see part of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training condition participants get feedback about the duration they process positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants only get feedback about the speed at which sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. Questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. There is also a follow-up measure 2 months after the training. Both groups (training and control) watch a psycho-education video before the start of the training.