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 560 of 612National Institute of Allergy and Infectious Diseases (NIAID)
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.
Harvard School of Public Health (HSPH)
Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India
The purpose of this study is to assess the effect of vitamin D and/or zinc supplementation on improving COVID-19 treatment outcomes. The effects of vitamin D, zinc, and both vitamin D and zinc together will be investigated among COVID-19 patients in India.
Hospices Civils de Lyon
There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode. Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.
Istituto Clinico Humanitas
Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers. In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide. Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis.
Laboratoires SMB S.A.
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Adaptive Phage Therapeutics, Inc.
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Some patients with COVID-19 have sequelae after the acute phase of infection. These sequelae can be physical (dyspnea, exercise intolerance, abnormal fatigue) but also psychic (anxiety, depression). Systemic sequelae have also been observed in pulmonary, cardiac, hepatic, renal, nervous or immune systems. Respiratory rehabilitation (RR) is indicated in these patients to help their complete recovery without sequelae. These patients' arrival and sanitary constraints imposed by COVID-19 changed the organization of Health Care Centers (HCC). Risk of contagiousness after the acute phase of infection still exists. Consequently, patients must respect a quarantine time on their arrival in HCC and then have no contact with other HCC patients to respect the barrier rules and social distancing measures. HCC accommodation capacities are reduced and this is to the detriment of patients with chronic diseases for whom RR is essential. Certain HCCs saturation can also be responsible for a non-proposal of RR in the care pathway of patients after COVID-19. To cope with the new constraints imposed by Covid-19 pandemic, telemedicine is being developed in the affected industrial countries. Some SRH physicians are starting to offer post-COVID-19 patients the possibility of carrying out a tele-rehabilitation program (TRR). Such a telemedicine program has been validated for people with respiratory failure. It allows the patient to follow his care program without leaving his home and it does not require the visit from a health professional. In addition to reducing the inflow of post COVID-19 patients in HCC, it allows fragile patients to respect social distancing. It could also contain virus spread virus on the territory by reducing patient movements. When choosing between RR and TRR, the clinician must ask himself two questions. Is TRR as efficient as RR for post-COVID-19 patients? Is there a profile of patients for whom either method gives better results? This study proposes to evaluate both methods: a 4-week TRR program vs a conventional RR program in post COVID-19 patients with sequelae. If the hypothesis that both methods have similar effects is verified, this would allow the generalization of the prescription of TRR. The benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients. There will also be collective public health benefits by maintaining sufficient access to HCC for patients with chronic diseases.
University of Cologne
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
Hospital do Coracao
PATIENTS WHO ARE ADMITTED TO HOSPITALIZATION IN HCOR AND WHO HAVE THE CONFIRMED DIAGNOSIS OF CORONA VIRUS, WILL BE ASKED TO CONSENT TO PARTICIPATE IN THIS STUDY THAT INTENDS TO STUDY THE EFFECTIVENESS OF THE REMOTE INTERCESSION PRAYER IN COMBATING THIS DISEASE.
Assistance Publique Hopitaux De Marseille
Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.