- 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 130 of 254University of Sao Paulo
Conditions: COVID19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
The physical inactivity promoted by the patient's hospitalization, including thoseinfected with the coronavirus, can lead to an important health impairment, includingatrophy and loss of muscle function. Thus, a prospective study will be conducted toassess the effect of a home-based exercise training program on health outcomes andquality of life in COVID-19 survivors.
University Hospital of Ferrara
Conditions: Covid19_rehabilitation
COVID19 patients survivors, after discharge from hospital show reduced lung function andreduced ability to exercise. Furthermore, mental health problems including stress,anxiety and depression and a low quality of life were observed. The prospectiveobservational study involves COVID19 patients who have needed rehabilitation at theUniversity Hospital of Ferrara. Patients receive comprehensive rehabilitation based ontheir specific needs in both acute and subacute rehabilitation. At the end of hospitalrehabilitation, patients are offered a program to be carried out at home for bothphysical and psychological problems. A range of demographic and clinical data will becollected. Patients will also undergo a battery of functional, cognitive andpsychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specificassessement (both clinical and instrumental) on the pain symptom experienced, wherepresent, will be done.
Cristina Avendaño Solá
Conditions: Acute Respiratory Distress Syndrome, COVID-19 Pneumonia
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy andsafety of MSC (mesenchymal stromal cells) intravenous administration in patients withCOVID-induced ARDS compared to a control arm.
Vladimír Džavík
Conditions: COVID19, Myocardial Injury
With the results of this study the investigators aim to identify an effective treatmentthat will reduce morbidity and mortality of patients with symptomatic COVID-19 infection,which would in turn reduce the burden on the healthcare system by decreasing the need forintensive care.Objectives: The main objective of this research is to determine if once weekly treatmentwith the GLP-1 agonist semaglutide for 4 doses will reduce cardiac as well as non-cardiaccomplications of COVID-19 infection.Study Plan: The study design is prospective randomized open-label blinded-evaluation(PROBE). Eligible patients with symptomatic COVID-19 infection and an enhanced riskprofile as described above, who have been admitted to hospital due to symptoms ofCOVID-19 infection but do not as yet require critical care will be approached toparticipate in this study. Provided there are no exclusion criteria and the participantsagree by means of documented written informed consent, The participants the participantswill be randomized to receive s.c. semaglutide 0.25 mg s.c. or control immediately afterrandomization and then 0.5 mg s.c. at Day 7, Day 14 and Day 21. Blood will be drawn atDay 7±2 and Day 14±2 for the cardiac troponin biomarker and safety parameters. ECG willbe obtained at Day 7±2 and Day 14±2. Primary outcome will be assessed on Day 28.Primary outcome measure: A composite of (1) death from any cause or (2) mechanicalventilation (invasive or non-invasive) at 28 days.Major secondary outcome measure:(1) an elevation to >99th percentile URL upper reference limit (URL) in those with abaseline cardiac troponin level ≤99th percentile URL; or 3x elevation from baseline inthose with a baseline cardiac troponin >99th percentile URL; measured at 1 week (7-days)post randomization.Other major secondary outcome measure:A composite of 1. Death from any cause, mechanical ventilation or vasopressor or ECLS support at 28 days 2. an elevation to >99th percentile URL in those with a normal baseline troponin level; or 3x elevation from baseline in those with a baseline troponin; measured at 1 and 2 weeks (7±2 and 14±2 days) post randomization.
Hillel Yaffe Medical Center
Conditions: Delivery; Trauma, COVID19
The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economicand mental-health challenges, especially for vulnerable populations such as pregnant andpost-partum females. In this study, we aimed to evaluate the relations between the fearof COVID-19 and postnatal depression symptoms.
Institut d'Investigació Biomèdica de Bellvitge
Conditions: Fibrotic Pulmonary Sequelae Post-COVID19 Infection
Study population: Patients with fibrotic lung sequelae after recovery from acute phase ofsevere COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administeredfor 24 weeks in patients who have pulmonary fibrotic changes after suffering severeCOVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung
Constant Therapeutics LLC
Conditions: COVID-19
Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinicalsymptoms including dyspnea, cough and fever, hospitalized in the KETER department inseveral hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml-control arm .Treatment duration: 14 days or until clinical improvement that enables discharge fromhospital.(the shortest time will be the limiting factor in treatment duration). Follow-up-30 days.14-30 days after discharge from hospital: we will contact the patient via phone to askquestions related to any possible adverse reaction to the drug and general health.
Uniformed Services University of the Health Sciences
Conditions: COVID19
This is a multi-center, observational study that will enroll 1) patients with severeCOVID-19 who have agreed to undergo therapy with Seraph® 100 under the existing EUA; 2)patients (medical record data) that have been previously treated with the Seraph® 100after the date of the EUA approval (17 April 2020), but before the date that the study isapproved at the study site, and 3) a convenience sample of patients (medical record data)in a historical control group who were admitted to the ICU at participating sites withsevere COVID-19 infection, meeting the EUA treatment criteria, but not treated withSeraph® 100 up to the time the PURIFY-OBS protocol is approved at the site
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions: Cytokine Storm, COVID-19
COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic byspreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-likeillness with expected recovery. According to World Health Organization, the overallglobal case fatality rate is currently estimated to be 2.9%. However, patients havingsevere or critical illness presenting with severe respiratory distress, ARDS or shocksuffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild orsevere cytokine storms in severe patients, which is an important cause of death. Anexaggerated and uncontrolled release of pro-inflammatory mediators by an overly activatedimmune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) whichhas an important role in the hemodynamic insults seen in very ill COVID-19 patients. Thisaberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acutekidney injury, etc. In this study, the investigators aim to estimate the burden ofcytokines and their correlation with the magnitude of the severity of COVID-19 illness inBangladeshi adults.
Francis Crick Institute
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