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 820 of 1095Atea Pharmaceuticals, Inc.
This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.
Reven Pharmaceuticals, Inc.
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.
United States Department of Defense
The purpose of this research is to understand if the study drug, also called sargramostim or Leukine®, can help prevent the worsening of COVID-19 when the study drug is inhaled. This study will also help researchers understand if inhaled sargramostim can help prevent visits to the emergency room or hospitalization, or death.
Oryn Therapeutics, LLC
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
University of Oklahoma
This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.
Ology Bioservices
Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19
Kitasato University
Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. This study will investigate whether ivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderate COVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlled trial. Subjects are assigned to two groups, the placebo group, and the ivermectin group. The target number of each treatment arm is 120, a total of 240 cases. A single oral administration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will be administered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primary endpoint with additional efficacy and safety of the process will be investigated.
University of Saskatchewan
VIDO has developed a vaccine called COVAC-2. The study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-2 contains a SWE adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The SWE adjuvant belongs to a family of oil-based adjuvants that have been given to millions of people around the world as part of influenza vaccines. The COVAC-2 vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent or reduce the severity of COVID-19 illness. In animal studies, the immune response generated by the COVAC-2 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. Phase 1 is a multi-centred trial of the COVAC-2 vaccine to be completed in Canada. It will be a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of three dosing levels (25, 50, and 100 µg protein) administered twice (4 weeks apart) in healthy adults 18 through 54 years of age (Phase 1a) and 55 years of age and older (Phase 1b). Enrolment and vaccination of participants will be staggered over time based on participant age and vaccine dose. Approval will be sought from the Data Safety Monitoring Board (DSMB) to proceed with the second dose in each group, to enroll at each dose level, and to enroll in the older age group for each dose level. Within the same age group, the 8 participants receiving the lowest dose are randomized with 4 participants receiving placebo; the 8 participants receiving the medium dose are randomized with 4 participants receiving placebo; and the 8 participants receiving the highest dose are randomized with 4 participants receiving placebo. Within each dose level of 12 participants, it is proposed to immunize a first cohort of 3 participants (including at least 2 active vaccine participants) and pending no holding rule is met after 48 hours, to immunize the remaining 9 participants within that dose level.
AbCellera Biologics Inc.
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
Institute of Tropical Medicine, Belgium
A fixed cohort of adults in rural Kimpese will be followed up every two months since they are assumed to be at above average risk of contracting COVID-19. Every two months these individuals will be interviewed with a focus on COVID-19 related symptoms and possible exposure to the disease and have their temperature recorded. A social mixing survey will also be carried out to assess human contact behaviour. The data generated will help inform mathematical modelling that can predict which proportion of the population per age group is likely to get infected once COVID-19 is introduced in this rural population, and the epidemic size if no intervention, as well as when targeted interventions are introduced. During the outbreak, physical distancing measures could be implemented. The monitoring of social contacts, again using a social-mixing survey, will contribute to the understanding of the impact of such measures in a rural context on transmission of SARS-CoV-2. The results from the seroprevalence over time, will be used to refine and validate the predictions from the modelling results, (re)calibrate the model where needed, and test hypotheses on transmission-dynamics of COVID-19. In case of an established epidemic of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the Health Zone of Kimpese, the sero-surveillance will be extended from an assumed high risk cohort to a representative sample of the overall population. Moreover, support to the COVID-19 control measures will be provided by the study team. The national guidelines recommend household transmission investigation for the first 100 confirmed laboratory cases. During the household visit, information on symptoms and one serum sample will be requested of all household members of the index case. If household members are present with symptoms and fever, the COVID-19 outbreak team of Kimpese will provide diagnostic testing and medical care.