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 260 of 458Mansoura University
A questionnaire is developed based on the literature and clinical experience. Initial testing will be performed on 20 patients. The first and second sectors include patient demographics and patient clinical diagnosis/scheduled surgery, respectively. The following sectors examine the process of delivering the cancellation/re-scheduling; care after cancellation and whether the procedure conducted elsewhere or not; and the impact of cancellation on patient health, career, and financial aspects.
Hamad Medical Corporation
The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted in a global pandemic. This infection has a special implication on the patient who complains from cardiac disease or acute cardiovascular condition and may result in cardiovascular complications such as myocardial infarction. For this end, we target to study this group of patient, who has a cardiac disease with COVID-19 in Qatar, in addition, the acute myocardial infarction with COVID-19 from the Gulf countries and collect all the related data to come with a comprehensive view about those patients.
Université de Montréal
Background: Traditionally, medical students learn surgical skills through the observation of a resident or a surgeon performing the technique. Due to inconsistent practice opportunities in the clinical setting, a disparity of skill levels among students has been observed. In addition, the poor availability of faculty professors is a limiting factor in teaching and adequately preparing medical students for clerkship years. With the ongoing COVID-19 pandemic, medical students do not have access to traditional suturing learning opportunities. Didactic courses are available on videoconferencing platforms, but they do not include technical training. Objective: Our overarching goal is to evaluate the efficacy of web-based peer-learning for advanced suturing techniques (i.e., running subcuticular sutures). The investigators will use GEN (Gamified Educational Network), a newly developed online learning tool. The investigators will assess students' ability to identify and to perform the right technique. The investigators will also assess students' satisfaction with regards to GEN. Methods: The investigators will conduct a prospective randomized controlled trial with blinding of expert examiners. First-year medical students in the Faculty of Medicine of Université de Montréal will be randomized to four groups: 1) control group, 2) self-learning, 3) peer-learning, and 4) peer-learning with expert feedback. Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. For our primary outcome, students' ability to identify the right technique will be evaluated before and after the intervention on GEN. They will view eight videos and rate the surgical technique using the OSATS (Objective Structured Assessment of Technical Skills) Global Rating Scale (GRS) and the Subcuticular Suture Checklist as evaluation criteria. For our secondary outcomes, students will anonymously record themselves performing a running subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent to analyze the overall performance of the platform. Results: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by our institutional review board (CERSES 20-068-D). No participants have been recruited yet. Conclusions: Peer-learning through GEN has the potential to overcome significant limitations related to the pandemic and the lack of availability of faculty professors. Further, a decrease of the anxiety related to traditional suturing classes can be expected. The investigators aim to create an innovative and sustainable method of teaching surgical skills to improve the efficiency and the quality of surgical training in medical faculties. With the current world events of COVID-19, the necessity for such tools are imperative.
Institut Bergonié
The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.
Fundación Santa Fe de Bogota
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.
Opera CRO, a TIGERMED Group Company
This is a multi-center, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy of Favipiravir combined with supportive care for adult patients with COVID-19-Moderate type.
Poudre Valley Health System
A pilot study to investigate the effects of the prone positioning (PP) on hospital patients diagnosed with COVID-19 pneumonia. Investigators that early self-proning may prevent intubation and improve mortality in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2). Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will be enrolled to the study. All participants will be screened and those that meet inclusion and exclusion criteria will be enrolled to one of two groups: one with prone positioning (on the belly) and the other with standard supine positioning (on the back). The patient and nursing staff will monitor times spent in various positions. Outcome measures include incidence of intubation, max oxygen requirements, length of hospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.
University Hospital Southampton NHS Foundation Trust
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial. Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation) Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30. Secondary Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L). Exploratory Objective: Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
King Faisal Specialist Hospital & Research Center
Rationale: Coronavirus disease 2019 (COVID-19) is spreading rapidly in the world with no proven effective therapy to date. Some patients with COVID-19 develop sever respiratory disease requiring ICU care. There is in vitro evidence that hypertonic saline (HTS) may be beneficial in reducing the inflammatory component in similar viral illnesses. Objective: To assess whether wearing a face mask sprayed with HTS (in addition to other COVID-19 treatments) leads to decreasing the severity of the respiratory symptoms resulting from COVID-19. Study design: Multi-centre trial Study population: Any patient older than 18 years of age with confirmed COVID-19 diagnosis who has any of the following respiratory symptoms or signs: - cough, - shortness of breath, - tachypnea (respiratory rate of 20 breaths / minute or more), - hypoxemia (O2 saturation 90% or less on room air) Intervention: Participants will be asked to wear a face mask for 20-30 minutes every 6 hours for the duration of their respiratory symptoms and/or signs. This inside surface of the face mask will be sprayed with 10-15 ml of HTS and allowed to air dry before the participant is permitted to wear it. A new face mask will be given to the patient every 24 hours. All participants will continue to receive their other COVID-19 treatments as per local hospital guidelines. Main study parameter: Improvement of the respiratory symptoms and signs on repeated measurement. Nature and extent of the burden and risks associated with participation, benefit: The burden of COVID-19 is very severe world wide. The trial duration is 3 months, with potential extension if deemed needed by interim analysis at the end of 3 months. There are no additional risks for participation in this study as only face masks will be used with no additional medications being given to the participants. In the future, the results of this study could lead to improved care for COVID-19 patients.
Assiut University
COVID19 is n outbreak with unpredictable outcome