- About
-
Projects
-
Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
-
Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
-
Column 1
- News and Events
- Expanded Access eRequest
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.
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 320 of 530Finnish Red Cross Blood Service
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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions: SARS-CoV-2, Vaccine, COVID-19
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
Conditions: COVID-19, SARS-CoV-2 Infection
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.
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Conditions: Myocardial Infarction, Heart Diseases
Myocardial infarction (MI), as one of the many complications of COVID-19, is one of thecontributing patients of patients' death. This study attempts on developing anintervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygenin cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patchdeveloped from amnion bilayer seeded with amnion epithelial stem cells and patient'sautologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG)surgery are given heart patch, and then patients condition are observed by ECG, Echo,blood test, and radiology (technetium-99m)
Cardresearch
Conditions: COVID19, SARS-Associated Coronavirus
The COVID-19 pandemic has been characterized by high morbidity and mortality, especiallyin certain subgroups of patients. To date, no treatment has been shown to be effective inpatients with early-onset disease and mild symptoms. Experimental studies havedemonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonideand Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggesteda reduced complications in patients with COVID-19 disease.
GlaxoSmithKline
Conditions: Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Coronavirus
The purpose of this study is to examine how patients with multiple myeloma (MM) have beenimpacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.The study will use a questionnaire to further understand how patients are being affectedand gather information in order to track the long-term effects of the coronavirus.The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes inmyeloma treatment and care, clinical trial familiarity, health and fitness, and qualityof life.This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.
Department of Health and Human Services
Conditions: SARS-CoV-2 Positive Patients
This is a prospective single-center study for the follow-up of SARS-CoV-2 positivepatients in the district of Konstanz (LKN). As part of the coronavirus pandemic, patientswith SARS-CoV-2 infection are currently being treated in the clinics of the LKN's healthnetwork at the Singen (Hegau-Bodensee Clinic) and Konstanz (Konstanz Clinic) locations.So far, there is little data on the long-term effects of SARS-CoV-2 infection. As part ofthis study, the disease progression of these patients will be monitored. Study objective:Prospective, controlled follow-up observation of SARS-CoV-2 positive patients regardingtheir secondary diseases and quality of life.
Assistance Publique - Hôpitaux de Paris
Conditions: COVID-19
The purpose of the study is to describe disability following hospitalization in people ofworking-age surviving COVID-19.
University of Minnesota
Conditions: COVID19, SARS-CoV Infection, ARDS, ARDS, Human
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patientson mechanical ventilation.
Cold Spring Harbor Laboratory
Conditions: COVID-19
The overall objective of this study is to evaluate the clinical efficacy of oralfamotidine in symptomatic non-hospitalized patients with confirmed COVID-19. This studyis expected to enroll up to 84 patients with mild to moderate symptoms divided into eachof the two study arms. Clinical outcomes of the two treatment arms will be compared. Thisstudy will be conducted virtually/remotely.