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 540 of 869Rennes 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.
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.
KGK Science Inc.
Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration. The objective of this study is to investigate the safety and efficacy of CARDIO supplementation in the recovery of those with COVID-19 infection following the guidance from public health by reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality.
Cambridge University Hospitals NHS Foundation Trust
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory droplet capture techniques for the detection of nCOVID-19. These are single use disposable breath capture devices with removable filters and fitted PVA strip that directly sample exhaled breath aerosols and therefore, directly sample the primary transmission route for the virus. They can be used independently and shipped for analysis for the presence of nCOVID-19 using established existing assays available in any reference lab. The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face mask vs. available diagnostic procedures in standard care and will also asses the feasibility of patient use of the equipment. Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient characteristics (e.g. age, sex) are collected. Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to obtain to address the primary study hypothesis. Due to the pre-test probability of patients being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a combination of imaging, viral diagnostics and clinical assessment will be used as the reference standard. When this number hits 100 the study will be discontinued. In total no more than 500 subjects shall be sampled in this trial.
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.
King's College London
Background The immediate psychological impact of COVID-19 is already emerging. The investigators are interested in the benefits of a self-management booklet focused on the current circumstances in response to the COVID-19 pandemic on people's physical and mental wellbeing. Who can participate? The investigators are looking for participants aged 18 and over who live in the UK and can read and write in English, without any current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe anxiety/depression), and who feel that their physical and/or mental wellbeing have been affected since the COVID-19 pandemic. What does the study involve? Eligible participants will complete questionnaires at baseline following which they will be randomly allocated to either receive the self-management booklet right away (via email) or after 4 months (waiting-list, in the meantime participants will be provided a link to educational materials). Participants will not be able to choose whether they will receive the self-management booklet right away or be in the waiting-list as a computer system (Qualtrics randomiser) will allocate them to one of the two groups at random. Participants in both conditions will be asked to complete online questionnaires at multiple time points, 2-months and 4-months after allocation. Participants in the waiting-list condition will also be asked to complete the same set of questionnaires at 6- and 8-months after allocation to assess how beneficial they found the self-management booklet. Participants will also be invited to take part in an audio-recorded interview after T2 to tell us more about how they found the self-management booklet or the educational materials. The investigators will select 30 participants (15 from each condition) for the interview out of those who opt-in to capture a wide range of experiences and backgrounds. What are the possible benefits and risks of participating? Risks to participants are small. Participants may find reflecting on the impact of COVID-19 on their lives distressing. However, these effects are anticipated to be short lived, as participants will learn psychological techniques during the intervention that can help them manage better in the current circumstances and improve their wellbeing. Where is the study run from? The lead site is King's College London. The study is run online via Qualtrics. When is the study starting and how long is it expected to run for? May 2020 to May 2021 Who is the main contact? Dr Federica Picariello federica.picariello@kcl.ac.uk
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.
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.