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 170 of 265Hôpital Européen Marseille
The purpose of the study is to Assess of Long-term impact post COVID for patients andhealth care professionals.The patients and medical staff will be followed for 2 years inorder to provide clinical and paraclinical data not yet published in the literature.
The Hospital for Sick Children
Convalescent Plasma for COVID-19 Research (CONCOR-Donor) study, is a national, naturalhistory study of plasma donors recovered from COVID-19. CONCOR-Donor study will addressimmune response, duration of protective immunity, and clinical factors and host geneticscontributing to the variability of immune response. We will also study long-term outcomesfrom COVID-19 infection. Results from the study will help define therapeutic strategiesfor COVID-19.
Public Health Foundation of India
A global study for a better understanding of the cardiovascular conditions that increasethe risk of developing severe COVID-19, and a better characterization of cardiovascularcomplications in hospitalized patients with COVID-19.
University of California, Los Angeles
This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
Poudre Valley Health System
A pilot study to investigate the effects of the prone positioning (PP) on hospitalpatients diagnosed with COVID-19 pneumonia.Investigators that early self-proning may prevent intubation and improve mortality inpatients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2).Up to 100 participants with a primary diagnosis of confirmed COVID-19 pneumonia will beenrolled to the study.All participants will be screened and those that meet inclusion and exclusion criteriawill be enrolled to one of two groups: one with prone positioning (on the belly) and theother with standard supine positioning (on the back). The patient and nursing staff willmonitor times spent in various positions.Outcome measures include incidence of intubation, max oxygen requirements, length ofhospital stay, ventilator-free days, worsening of oxygenation saturation, and mortality.
Karolinska Institutet
In this study we cross-reference several nationwide high-quality Swedish registers inorder to study risk factors for severe Covid-19 outcomes.
William B. Ershler, MD
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN®injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by thethymus gland. Ta1 is a biological response modifier which activates various cells of theimmune system, and is therefore expected to have clinical benefits in disorders whereimmune responses are impaired or ineffective, including acute and chronic viral andbacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stagerenal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease andfrequent burden of comorbidities, also have increased risk of exposure to communicablediseases as they are treated several times each week at hemodialysis centers with severalother patients and clinic staff in attendance. The majority of patients are over 60 yearsof age and many are receiving immunosuppressive medications. Accordingly, ESRD patientsare particularly susceptible to COVID-19 infection. Ta1 has been shown to be safelyadministered to hemodialysis patients. It is our hypothesis that a course of Ta1administered to individuals with ESRD will reduce the rate and severity of infection withCOVID-19.
Celltex Therapeutics Corporation
This is a phase 2 multi-center, double-blind, randomized, placebo-control clinical trialwith 200 subjects who have never been infected by COVID-19 (SARS-Cov-2 virus screen testnegative, no blood SARS-Cov-2 IgM and IgG antibodies detected during enrollment) followedby a pilot study of 5 subjects to demonstrate the safety of proposed three-dose regimenof autologous AdMSCs infusions. The 100 study subjects who have previously banked theirAdMSCs with Celltex, will receive three doses of autologous AdMSCs (approximately 200million cells) intravenous infusion every three days. The 100 subjects in the controlgroup who have previously banked their AdMSCs with Celltex will not receive any Celltex'sAdMSC therapy but placebo treatments. All subjects are monitored for safety (adverseevents/severe adverse events), COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα)tests and disease severity evaluation for 6 months after the last dose of AdMSC infusionfor the study group and 6 months after the enrollment for the control group.
University of Milano Bicocca
This is an observational study. The aim is to describe the natural history and clinicalevolution over time of hospitalized patients affected by Severe Acute RespiratorySyndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of thedisease and improve therapeutic procedures.
Sheba Medical Center
The aim of this preliminary study is to describe the potential decline in forcedexpiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by homespirometry in high-risk subjects infected with COVID-19. We hypothesize that themagnitude of such a decline in FEV1 and/or FVC may be associated with clinicaldeterioration and hospitalization. The study will ultimately inform a larger subsequentRCT that will evaluate the efficacy of home spirometry in the early detection (prerespiratory symptoms) of respiratory complications and therefore prompt early medicalattention which is a key for improving outcome.