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 80 of 87Sultan Qaboos University
Objective: To determine whether NIV delivered through helmet interface reduces intubation rate among patients with COVID-19 ARDS compared to face-mask NIV and HFNC. Design, setting & participants: Two-center randomized clinical trial of 360 patients with mild to moderate ARDS and confirmed COVID-19 requiring non-invasive ventilation between August 2020 to January 2021. The patients with respiratory rate (RR) more than 30/min or oxygen saturation (SpO2) less than 90% or PaO2/FiO2 ratio less than 300 despite standard oxygen therapy by face mask (
Biomedical Advanced Research and Development Authority
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.
The Cleveland Clinic
This study evaluates operative and non-operative management of acute appendicitis (infection or inflammation of the appendix) and acute cholecystitis (inflammation/infection of the gallbladder) in patients with active mild to moderate COVID-19 infection. The hypothesis is that COVID+ patients with uncomplicated acute appendicitis or acute cholecystitis amendable to a laparoscopic procedure can have safe operative outcomes compared to those managed non-operatively.
Meyer Children's Hospital IRCCS
The new coronavirus (SARS-CoV-2) causing COVID-19 is an RNA virus coated with a capsid and a peri-capsid crossed by glycoprotein structures. The external proteic structure, which attacks human cells, is a potential target to therapeutic interventions against virus replication in airways. Since high temperature can cause irreversible denaturation of proteins and loss of SARS CoV and SARS CoV-2 infectivity was obtained after heating at 56 ◦C for 15 and 30 min in liquid environments respectively, we designed a protocol aimed at damaging SARS-CoV-2 capsid through steam inhalation cycles. Although the ominous consequences of COVID 19 infections has directed medical attention toward solidly established medical approaches, the European Pharmacopoeia VI edition also quotes steam inhalations as a procedure to treat of respiratory diseases. Based on these suggestions we established a quasi-randomized clinical trial enrolling 200 asymptomatic or paucisymptomatic patients in whom rhino-pharyngeal-swab revealed a SARS-CoV-2 infection. The study protocol consisted of exposure of airway mucosae to humidified steam (pH 8 per NaHCO3 and hypertonic 15 g/L NaCl) through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days. The objective of the study is to reduce the viral shedding using steam inhalations.
Aethlon Medical Inc.
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
Erasmus Medical Center
An effective, widely available, and safe treatment that can decrease the duration, severity and fatality of COVID-19 is urgently needed. Also, in the most affected regions the pressure on health care systems including ventilator support capacity can be a limiting factor for survival. Initial studies including from our group indicate that administering convalescent plasma containing high titers of neutralizing antibodies to COVID-19 patients who are already relatively late during the disease course after hospital admission is not effective, which can be explained by high titers of autologous antibodies present in patients. Thus, the antiviral capacity of convalescent plasma is hypothesized to be best positioned early in the disease course and in patients at increased risk for a severe disease course. If effective, any treatment that decreases the need for hospital admission is very valuable but so far, no COVID-19 treatment has been shown to prevent clinical deterioration when given before patients are admitted to the hospital. Primary objective: To evaluate the efficacy, feasibility and safety following the administration of convalescent plasma (ConvP) as a therapy for outpatients diagnosed with COVID-19 at increased risk for an unfavourable clinical outcome and within 7 days after symptom onset. Study design: This trial is a nationwide multicenter, double blind, randomized controlled trial in the Netherlands. Patients will be randomized between the transfusion of 300mL of convP versus regular fresh frozen plasma (FFP). Patient population: Patients with polymerase chain reaction (PCR) confirmed COVID disease with less than 8 days of symptoms, age 70 or older or 50-69 years with at least 1 additional risk factor for severe COVID-19 are eligible. Intervention: 300mL of convP with a minimum level of neutralizing antibodies. A total of 690 patients will be included. Expected duration of accrual: 18-24 months Duration of follow up :Day 28 for the primary endpoint
Assistance Publique - Hôpitaux de Paris
The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.
NGM Biopharmaceuticals, Inc
This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).
Arcturus Therapeutics, Inc.
This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.
University Hospital, Strasbourg, France
Diabetes is a major factor of morbi-mortality in Covid-19 infection. Currently, steroid therapy is required in patients under oxygen therapy. This treatment is associated with hyper glycaemia in patients with diabetes. Recommendations for the management of diabetes during Covid-19 infection is to use insulin treatment. The majority of units involves in the management of patient with Covid19 infection are not the experience in managing intensive insulin therapy and the time to ensure this follow-up. All the data in the literature are in favor of a positive impact of telemedicine on the metabolic control of diabetic patients. However, the routine use of telemedicine and more particularly tele-expertise within hospital units is very underdeveloped in France. The epidemic of Covid-19 represents a unique situation where the health authorities recommend to physicians to use telemedicine to ensure the follow-up and optimal management of patients. The aim of this study was to compare the metabolic control of diabetic patients infected with Covid-19 followed in tele-expertise to a group of diabetic patients infected with Covid-19 managed in standard conditions.