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COVID-19 Clinical Trials and Expanded Access

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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.

Search Tips

To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.

Displaying 180 of 254

Corporacion Parc Tauli

Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

Conditions: COVID-19, Endothelial Function

The purpose of this study is to characterize microvascular reactivity on the forearmmuscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients,and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.

McGill University Health Centre/Research Institute of the McGill University Health Centre

COVID-19 Immunologic Antiviral Therapy With Omalizumab

Conditions: COVID19

To evaluate if omalizumab is effective in decreasing mortality in severe hospitalizedCOVID-19 cases.

Finnish Red Cross Blood Service

Convalescent Plasma in the Treatment of Covid-19

Conditions: COVID19

This study investigates the possible adverse effects and effectiveness of convalescentplasma for patients infected with SARS-CoV-2. Following provision of informed consent,patients will be randomized into three groups: High-titre convalescent plasma, low-titreconvalescent plasma or placebo. Primary outcomes of the study will cover safety andeither intubation or initiation of systemic corticosteroids. Safety information collectedwill include serious adverse events judged to be related to administration ofconvalescent plasma. Microbiological and other laboratory parameters will be followed up.

University of Malaga

Digital Physiotherapy Practice in Long Covid-19 Patients

Conditions: Long COVID-19 Syndrome

The COVID-19 can cause important sequels in the respiratory system by bilateral pneumoniaand frequently presents loss of strength, dyspnea, polyneuropathies and multi-organicaffectation. Long COVID-19 has been defined as the condition occurring in individualswith a history of probable or confirmed SARS-CoV-2 infection, with related symptomslasting at least 2 months and not explainable by an alternative diagnosis. The practiceof digital physiotherapy presents itself as a promising complementary treatment method tostandard physiotherapy, playing a key role in the recovery of function in subjects whohave passed the disease and who maintain some symptomatology over time. The aims of thisresearch are to explore the effect of a digital physiotherapy intervention on functionalrecovery in patients diagnosed with Long COVID-19 and to identify the level of adherenceto the treatment carried out. Physiotherapy interventions acquires a fundamental role inthe recovery of the functions and the quality of life. As secondary objectives, the aimis to identify the satisfaction and perception of patients with the intervention and thepresence of barriers to its implementation (throught a qualitative research), as well asto evaluate the cost-effectiveness from the perspective of the health system. Aquasi-experimental pre-post study assessed initially and at the end of the 4-weekintervention the functional capacity (1-min STS and SPPB) and the adherence (software).The hypothesis of this research is that the implementation of a TR program presentspositive results. If hypothesis is confirmed, that would be an opportunity to define newpolicies and interventions to address this disease and its consequences.

Francis Crick Institute

SARS-CoV-2 (COVID-19) Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)

Conditions: SARS-CoV Infection

The study aims to investigate SARS-CoV-2 susceptibility, transmission and diseaseseverity in healthcare workers and patients.Residual specimens from an existing collection of samples in viral inactivating bufferand derivatives and serum from the Crick COVID-19 Consortium Testing centre (Cohort A1)and additional biological material collected prospectively (Cohorts A2 and B) will beused for research into SARS-CoV-2 transmission, evolution and immune control. Thistesting centre is a partnership between UCLH and The Francis Crick Institute to provideCOVID 19 RT PCR testing for healthcare workers (HCWs) and patients in London Hospitalsand care homes. A third group (Cohort C) of the study will allow for collaborative workwith other REC approved research studies that have used the Crick COVID-19 ConsortiumTesting centre and will involve the use of study samples already collected from eachstudy to be analysed under the SARS-CoV-2 Longitudinal Study end points

Assistance Publique - Hôpitaux de Paris

French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

Conditions: COVID19

The purpose of this study is to describe post-intensive care syndrome (PICS) of patientssurviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recoveryprocess from hospital to home return

Charite University, Berlin, Germany

Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19

Conditions: COVID-19 Pneumonia

The aim of the joint project PROVID is to contribute to better outcome prediction forCOVID-19 patients, to better clinical management, and to the development of newtherapies. To this end, the investigators will collect detailed data on the course ofCOVID-19 patients and deeply characterize them at the molecular level. The investigatorsalso aim to identify compounds with the potential to improve outcome.The PROVID-PROGRESS study is being carried out as a prospective, longitudinal,multicenter observational study (case cohort study) with material asservation forgenomic, transcriptomic and proteomic analyzes on adult patients with COVID-19.

International Vaccine Institute

Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.

Conditions: COVID-19 Disease

To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), theinvestigators will conduct a phase 3, individually randomized, observer-blind, controlled(influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccineagainst any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell)manufactured by the Beijing Institute of Biological Products (BIBP), China NationalBiotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and receivedemergency use authorization (EUA) from World Health Organization (WHO).

Hemex Health

Gazelle COVID-19 Test Clinical Accuracy Protocol

Conditions: COVID19

Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Readerintended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasalswab specimens from individuals who are suspected of COVID-19 by their healthcareprovider within 5 days of symptom onset. The study will be conducted To obtain data tomeasure the positive percent agreement and negative percent agreement of the GazelleCOVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).Thestudy will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swabsamples. This study will primarily assess Gazelle COVID-19 Test performance onsymptomatic subjects (within five days of onset of symptoms) at point of care (POC). Asubset of asymptomatic subjects will be enrolled after the symptomatic subject enrollmentis complete.

Centre Hospitalier Universitaire de Nīmes

CT Biomarkers Identification by Artificial Intelligence for COVID-19 Prognosis

Conditions: COVID-19

The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificialintelligence by deep learning would generate imaging biomarkers linked to the patient'sshort- and medium-term prognosis.The purpose of this study is to rapidly make available an early decision-making tool(from the first hospital consultation of the patient with symptoms related to SARS-CoV-2)based on the integration of several biomarkers (clinical, biological, imaging by thoracicscanner) allowing both personalized medicine and better anticipation of the patient'sevolution in terms of care organization.

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Status

  • (-) Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (76)
  • Drug (64)
  • Biological (35)
  • Diagnostic Test (29)
  • Behavioral (10)
  • Device (8)
  • Procedure (6)
  • Combination Product (5)
  • Dietary Supplement (4)
  • Radiation (3)

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© Reagan-Udall Foundation for the FDA