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 50 of 268University Hospital, Rouen
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection ofIgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of avery large number of rapid diagnostic unit tests, a few dedicated high throughputautomated systems or reagents on existing open systems. The offer will continue to expandin the coming months.In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HASreport of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific councilconcerning the potential use of these serological tests at the end of the COVID-19epidemic, the Virology laboratory wishes to validate the sensitivity and specificity ofthe tests it intends to use.
Genova Inc.
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalizedmoderate COVID-19 patients
Cytocom, Inc.
This is a randomized, single blind, study. Males and females meeting inclusion criteriawho have symptoms of mild COVID-19 and in whom a positive PCR result for SARS-CoV-2 isobtained may be enrolled to the study treatment within 72 hours of the positive PCRresult. Eligible patients are those considered to be at high risk for COVID-19 diseaseprogression. This includes patients ≥ 65 years of age or with any one or more of certainmedical conditions including: cancer, COPD, cardiovascular disease, immunocompromisedstate resulting from solid organ transplant, obesity, sickle cell disease, history ofsmoking, and diabetes.
University of British Columbia
Coronavirus Disease 2019 (COVID -19) is the largest public health crisis in over acentury. There is an urgent need for high-quality population-level data to understandmodifiable risks for disease severity, transmissibility, and to develop evidence-basedprevention (i.e. vaccination), treatment and resource allocation strategies.The Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) created apopulation-based registry of suspected and confirmed consecutive cases of COVID-19. Thepurpose of this registry is to derive and validate clinical decision rules, evaluatediagnostic tests and vaccine effectiveness, and complete cohort, case-control andobservational studies to inform the pandemic response.
Kitasato University
Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when thesymptom and clinical findings exacerbate to a moderate level, patients are admitted.There is no standard treatment for mild cases. This study will investigate whetherivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderateCOVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlledtrial. 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 oraladministration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will beadministered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primaryendpoint with additional efficacy and safety of the process will be investigated.
Shin Poong Pharmaceutical Co. Ltd.
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacyof pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19).Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name ofPyramax® or Artecom® as a treatment for malaria. The study will be conducted in twostages: open-label (Stage 1) and double-blind (Stage 2).Up to approximately 402 participants (20 participants in Stage 1 and 382 participants inStage 2) are planned to be enrolled in the study and will be randomized to receive eitherArtecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will bedetermined by the participant's body weight, according to previously establishedguidelines.An independent Drug Safety Monitoring Board (DSMB) will be established to review thesafety at regular intervals during the conduct of the trial. The DSMB will be subject toa Charter and will review after 20 participants have been recruited, and thereafter when191 participants have been recruited.Ad-hoc DSMB meetings may be held at any time during the study if there are any majorsafety concerns. A final DSMB will be conducted when all participants have been recruitedin the trial.
Assiut University
To register pathological events occurring to all acute coronary syndrome patients comingto Assiut university heart hospital through one year during COVID- 19 pandemic
Corporacion Parc Tauli
The purpose of this study is to monitor short-term changes in tissue oxygen saturationand local blood flow as results of changing from supine to prone position in ARDSCOVID-19 patients
Sheba Medical Center
The study aim to test proof of concept of CBD treatment for efficacy and safety inpatients suffering with mild COVID-19 infection. The CBD will be delivered via oildroplets not containing THC, compared to placebo.
National Institute of Mental Health (NIMH)
People have had to make a lot of changes to their lives due to the COVID-19 healthcrisis. Most experts agree that social distancing and other safety measures have taken atoll on people s mental health. Amish and Mennonite communities often have largefamilies. They may have limited access to health care. Their lifestyle is based oninteraction and group events rather than technology. So people in Amish and Mennonitecommunities may experience the pandemic in their own special ways.Objective:To describe the relationship between stress related to the pandemic and self-ratedmeasures of mental health symptoms and distress among Amish and Mennonite people withbipolar disorder and related conditions, and their family members.Eligibility:Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083).Design:Participants will be mailed 4 surveys. One survey will ask about depression symptoms. Onesurvey will ask about mania symptoms. One survey will assess a broad range ofpsychological problems. One survey will assess the impact of COVID-19 on their mentalhealth. They will fill out the surveys 4 times over 24 months.The surveys will not include participants names, just codes. This will help protectprivacy.Data collected in 80-M-0083 will be used. This includes data about participants genes,medical conditions, and assessments.Participants will get an 800 number they can call to speak to the research team. They canalso write to the team if they prefer. Participants who wish will get referrals formental health services. Participation will last up to 24 months. There will be an optionfor recontact in the future.