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 500 of 794Rennes University Hospital
Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.
Obafemi Awolowo University
Finding effective strategies to treat or prevent the novel coronavirus disease that started in 2019 (COVID-19) is a global public health priority. Potential therapeutics and vaccines are now being investigated in over 1500 clinical trials. Clinical features of the disease include overproduction of reactive oxygen species which induces oxidative stress responses and contribute to acute lung injury. This presents a potential treatment strategy involving antioxidation therapy. In this pilot study, 90 COVID-19 patients aged 18-75 years will be recruited into two groups. The 45 patients in group 1 will receive the standard of care determined by their primary care providers while the 45 patients in group 2 will receive both the standard of care combined with daily antioxidant supplement for 14 days. All patients will be monitored for a total of 28 days with daily monitoring of symptoms and nasopharyngeal swab for SARS-CoV-2 test on days 3, 7, 14 and 28. The study will compare the following between the two groups: (1) the proportion of patients with clinical improvement (defined as live discharge from hospital, decrease of at least 2 points from baseline on a 7-point ordinal scale, or both), and (2) the proportion of patients with negative SARS-CoV-2 test by PCR on days 3, 7, and 14.
University Hospital, Toulouse
The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease. These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.
Misr International University
Spread of COVID-19 in the world has led to a shift in teaching and learning techniques to online methods in order to prevent transmission of the disease. Misr International University (MIU) has an established online learning system that has been used together with face-to-face classes. The aim of this study is to assess and compare the satisfaction and perceptions of full-time teaching staff and undergraduate students regarding online learning during COVID-19 crisis.
University Hospitals of Derby and Burton NHS Foundation Trust
Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in December 2019. It quickly spread to rest of the world and was declared pandemic by World health organisation. Initial case series focused on lung involvement in the form alveolar haemorrhages and respiratory failure. However, subsequently, there have been reports of kidney involvement resulting in severe acute kidney injury. However, the reported incidence from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease is lacking.
Columbia University
The purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe hypoxemic respiratory failure.
Direction Centrale du Service de Santé des Armées
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff. A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic. Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool. Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding. The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.
Postgraduate Institute of Medical Education and Research
Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of people with high mortality because of the large population along with very high population density. At present there are no definitive therapeutic drugs or vaccine are available for the treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being given to COVID-19 cases along with isolation and quarantine measure are being taken for the suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection . Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ), has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients for lifelong without much side effect, so it allow for higher dose without any significant side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of the SARS-CoV-2 infection. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of labarotory confirmed COVID-19 cases. But there is still lack of significant scientific data to prove or disprove the efficacy of HCQ for the treatment and post exposure chemo-prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar Pradesh. Among this Punjab have highest population of non residential Indian (NRI) and most of them have returned home. This put our institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. All asymptomatic individuals who have undertaken international travel in last 2 weeks and all asymptomatic individual with direct contact with laboratory confirmed cases will be advised for home quarantine for 2 weeks along with social distancing and personal hygiene. They will be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals will be assigned into one post exposure prophylaxis (PEP) group and one control group as per inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be directly included in the control group. All symptomatic individual, and all health care workers related to suspected or proven COVID-19 will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will not receive HCQ. Both the groups will receive standard care of therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene. They will be followed up for 4 weeks telephonically or physically as and when required and will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore throat, shortness of breath, diarrhoea, myalgia.During follow up nasopharyngeal and or throat swab of the participants will be taken for processing reverse transcription polymerase chain reaction (RTPCR) for the detection SARS-Cov-2 RNA to confirm CoVID-19. Samples for RTPCR will be taken when any asymptomatic participants become symptomatic and by the 5-14 days of contact in asymptomatic participants through in-hospital visit at the institute's communicable disease ward isolation. The participant with RTPCR positive and with or without symptoms will be defined as definite COVID-19 case and the RTPCR negative symptomatic participant will be defined as probable COVID-19 case. Asymptomatic participants with negative RTPCR will be defined as non-COVID case. Incidence of COVID-19 or probable COVID-19 or non-COVID case in previously asymptomatic participants will be compared between the PEP and control groups.
Centre Hospitalier Universitaire de Nīmes
To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.
Central Hospital, Nancy, France
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known. The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form. This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.