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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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 130 of 370SK Bioscience Co., Ltd.
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded,age-escalating study to assess the safety, reactogenicity and immunogenicity of a SKSARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or withoutAS03 in healthy younger and older adults.
University of Campania Luigi Vanvitelli
In order to prevent reinfection, it is needed to detect the cellular-mediated immuneresponse to the Sars-CoV-2 infection. The first goal of this study will be to detect thecellular-mediated immune response in patients affected by COVID-19 (with or withoutvaccination) and healthy subjects who undergone vaccination program. The second goal ofthis study will be to identify the genetic and epigenetic biomarkers that influenceindividual immunological response and clinical evolution to the severe manifestations ofthe COVID-19.
National and Kapodistrian University of Athens
Determination of both the degree and duration of the immunity provided after receivingthe BNT162b2 vaccine against SARS-Cov-2.
Sanofi
Strengthening outpatient low respiratory tract infection surveillance to document theburden of Respiratory Syncytial Virus (RSV)
Palas GmbH
The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe AcuteRespiratory Syndrome Corona Virus 2) positive and negative children and adults with theResp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratoryaerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established.Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive andnegative participants (children and adults) will be conducted. In addition to themeasurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratoryinflammatory markers will be analyzed.
Gruppo Italiano Malattie EMatologiche dell'Adulto
Multicenter retrospective and prospective observational study based on the collection ofsequential anonymized data from principal Italian ITP centers, to describe the clinicalcourse of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patientsdeveloping de novo ITP.
Radboud University Medical Center
SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists,physical therapists, occupational therapists and speech and language therapists) mightplay an important role in the recovery of patients with COVID-19 who experiencelimitations in daily physical functioning and participation. However, the evidence basefor allied healthcare in patients with COVID-19 has yet to be established. To facilitatecare for people recovering from COVID-19 and to establish this evidence base, the Dutchministry has created a temporary regulation for primary care allied healthcarespecifically for patients with COVID-19.Objective: This study is setup alongside the temporary regulation and aims to evaluatethe longitudinal recovery trajectories and related costs of patients who visited aprimary care allied healthcare professional for the management of severe symptoms andactivity limitations and/or participation restrictions related to COVID-19.Study design: Prospective cohort study. Study population: 1,315 adult patients recoveringfrom COVID-19 with severe symptoms and activity limitations and/or participationrestrictions, and who are referred to a primary care allied health professional by ageneral practitioner or medical specialist within four months of the start of the diseasewill be eligible for this study.Intervention (if applicable): Although the nature of this study is non-experimental, theallied healthcare intervention can be considered experimental due to the novelty of thedisease.Main study parameters/endpoints: The primary outcome domain of this study isparticipation measured with the Utrechtse Schaal voor Revalidatie - Participatie(USER-P). The primary endpoint is set at 6 months. A 5 point difference will beconsidered clinically relevant for patients with COVID-19.Nature and extent of the burden and risks associated with participation, benefit andgroup relatedness: There are no specific risks involved with participation in this study,as it entails the completion of questionnaires over the timeframe of one year (at thestart of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74survey items. Input from patient representatives suggested that this number of items wasfeasible, especially because participants are allowed to complete the survey over anumber of days. Finally, none of the items in the survey are considered emotionallydistressing. The prescribed interventions are conform the recommendations of the bestavailable evidence and are in line with usual allied healthcare interventions. Therefore,risks are likely to be negligible conform usual allied healthcare.
Kafrelsheikh University
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 andenhancement of Its spike protein based vaccine efficacy and safety.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The coronavirus disease 2019 (COVID-19) caused by the infection of severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 millionconfirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoingpandemic still poses unprecedented global threat to public health system worldwide. OnDecember 31, 2020, the joint prevention and control agency of China Council announcedthat Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by NationalMedical Products Administration, and the protection rate was 79.34%. So far, more than198 vaccines were currently in preclinical or clinical development. The investigatorsaimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2vaccine Induced adaptive immune responses.
Tampere University Hospital
A Study of the relation of COVID-19 infection and its severity to upper and lower airwaynitric oxide, upper airway viral load and lung function.