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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Displaying 70 of 276Rutgers, The State University of New Jersey
Our long-term goal is to protect the health care workforce (HCW) caring for SARS-CoV-2-infected patients, their families, communities, and the general population. Our specific objective is to rapidly establish a prospective cohort to characterize the factors related to viral transmission and disease severity in a large healthcare system. We addressed this hypothesis by recruiting and longitudinally following 546 HCW and a comparison group of 283 non-HCW within a large academic health system, Rutgers Biomedical and Health Sciences (RBHS). By intensively following participants over a several year period (2020-2024) and collecting serial biospecimens (nasopharyngeal/throat swabs, blood, and saliva) and questionnaire data at multiple time points, we will uniquely characterize SARS-CoV-2 transmission and risk factors for COVID-19 among HCW and our larger academic community.
Gangnam Severance Hospital
There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2. - Primary end point: comparison the rate of COVID-19 between PEP with HCQ and control group. - Secondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment). - Safety comparison: Safety verification by identifying major side effects in the HCQ group."
Egyptian Military Medical Services
The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
Pfizer
The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization. Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1. Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate. Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET/ED/EOT visit, and on Day 60. An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.
ElectroCore INC
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.
Biontech SE
This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.
Stanford University
The purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.
University of Pennsylvania
The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.
Medical University of Graz
We hypothesize that the intake of Omni-Biotic® 10 AAD can reduce intestinal inflammation and improves dysbiosis in Covid-19 disease. We further hypothesize that Omni-Biotic® 10 AAD can reduce the duration of diarrhea, stool frequency, improve stool consistency, improve other gastrointestinal symptoms of Covid-19, reduce disease duration and severity. The investigators aim to perform a randomized, double blind, placebo-controlled study using telemedicine in patients with Covid-19 disease.
Brigham and Women's Hospital
This will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age >18 years old) with functioning renal transplants admitted to hospital with confirmed COVID-19 disease.