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 130 of 720Centre Hospitalier Régional d'Orléans
The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19 (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to 40%, the most serious is acute respiratory distress syndrome (ARDS). The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation in mild forms to invasive mechanical ventilation in the most severe forms. Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al showed that PP and high flow oxygenation reduced the intubation in patients with moderate to severe ARDS. The investigators hypothesize that the use of PP in spontaneously ventilation patients under oxygen standard could decrease incidence of intubation or non-invasive ventilation or death compared to conventional positioning management in medical departments.
University of Manchester
A team at the University of Manchester are developing a test that tcould be helpful in detecting immunity to the Coronavirus (which causes the COVID-19 disease) in participants with inflammatory arthritis. It is based on a flu assay has already developed; the team will replace the flu antigen with a Coronavirus antigen to see if it is effective. This project aims to develop a test to see if people who have had the virus have developed immunity to it. This could help to predict who might or might not get the disease a second time, who should stay at home to be protected from potential infection or who will not develop any symptoms, even if exposed to the virus. When vaccination trials against the Coronavirus will be launched, this test could also help to see if the vaccine is effective.
Pfizer
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - As a booster; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.
Coalition for Epidemic Preparedness Innovations
2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.
University Hospital, Strasbourg, France
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms. The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.
WINFOCUS-France
With the influx of patients suspected of Covid-19 and the limited number of hospital beds, there is a need for sensitive triage to detect patients at risk of pulmonary complications and therefore requiring hospitalization, but also specific triage to safely discharge patients without risk factors or signs of clinical or ultrasound severity. The use of pulmonary ultrasound in addition to clinical assessment seems appropriate. Indeed, it allows early detection of signs of pneumopathy which, in the current context, most often correspond to Covid-19. These signs include B-lines, which indicate interstitial pulmonary oedema, and an anfractuous and thickened pleural line, or even centimetric parenchymal condensations with a low level of pleural effusion. Conversely, the presence of a medium to large pleural effusion is not very suggestive of the diagnosis of Covid-19. In addition, a lung ultrasound score has been developed and validated to assess the severity of acute respiratory distress and predict the occurrence of acute respiratory distress syndrome. It is based on the performance of a 12-point (6 per hemi-thorax) pulmonary ultrasound with the collection of the presence of B-lines, condensation or pleural effusion. In the hands of a trained operator, this examination takes only a few minutes. The aim of the study is to develop a score based on clinical and ultrasound evidence to allow early and safer referral than that based on clinical evidence alone. To do this, the study will retrospectively collect clinical and lung ultrasound data from departments that use this technique on a daily basis.
Central Hospital, Nancy, France
This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.
Hôpital Lariboisière, AP-HP
This study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.
Harvard School of Public Health (HSPH)
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.