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 690 of 757University of Sao Paulo
This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.
Hospital de Clinicas de Porto Alegre
A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
VA Office of Research and Development
This is study is comprised of three approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, post-discharge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
Oslo University Hospital
Neurologic, neuropsychological and neuropsychiatric symptoms, signs and diagnoses are increasingly being reported in COVID-19 patients. However, the extent and implications of such "NeuroCOVID" involvement, as well as blood and MRI biomarkers for neurological and psychiatric COVID-19-affection and treatments, warrants further studies. The investigator will perform a national study with clinical and biomarker assessments of NeuroCOVID in approximately 150 Norwegian patients, recruited from ongoing COVID-studies in Norway as well as from neurological departments in Norway. The investigator will define the burden of neurological, psychological and psychiatric complications of COVID-19 disease and identify clinical characteristics and biomarkers for both short- and long-term neurological treatment and rehabilitation. Blood samples for biomarker analyses, brain MRI, clinical neurological, neurophysiological and neuropsychological assessments will be performed at 6 and 12 moths after acute disease,
Kafrelsheikh University
Combination of Chemopreventive agents (All- Trans Retinoic Acid and Tamoxifen) as potential treatment for the Lung Complication of COVID-19 Abstract Angiotensin-converting enzyme (ACE2) protein found on the cell membranes is the target of SARS-CoV-2 for entering into the host cells. Viral spike protein-binding with ACE2 down-regulates it. As ACE2 is known to protect the lung from injuries, SARS-CoV-2-induced ACE2 deficiency may expose patients to lung damage. In this Review, we use established and emerging evidence based on the findings of previous studies and researches to propose a testable hypothesis that Combination of chemopreventive agents (All Trans Retinoic acid and Tamoxifen) can be tested to prevent inflammatory complication in severe acute respiratory syndrome coronavirus 2 infection via two mechanisms by inhibiting bradykinin B1,B2 receptors expression and upregulating the depleted ACE2 in COVID-19 . Bradykinin B1 receptors are not expressed under physiological conditions but are induced under inflammatory conditions. Here we hypothesize that permanent attack and invasion of COVID-19 to lung epithelial cells via binding to ACE2 leads to tissue injury and inflammation and that increases BK levels and BK-B2-receptor (B2R) stimulation A study reported that tissue injury and inflammation increases BK levels and BK-B2-receptor (B2R) stimulation. We suggest that Bradykinin mediates and induces lung injury, proinflammatory cytokines and inflammation likely precipitates life threatening respiratory complications in COVID-19. Further experiments showed that BK treatment stimulated IL-6 production On the other hand a study reported that cells treated with Retinoic acid and Tamoxifen for 48 h significantly decreased the BK-B2 receptor protein levels (70.3 ± 0.6% vs. 100% of control, P < 0.05). Retinoids inhibit bradykinin B1 receptor-sensitized responses and this action could participate in their anti-inflammatory and immunomodulatory effects. In addition retinoic acid, is known to possess in vivo anti-inflammatory, anti-platelet and fibrinolytic activities. A study investigated the in vitro thrombin and platelet aggregation inhibitory activities of retinoic acid and retinaldehyde.Retinoic acid, retinaldehyde and retinol exhibited potent inhibition of thrombin, with IC50 values of 67μg/ml, 74μg/ml and 152μg/ml, respectively for the inhibition of thrombin (Sigma); and 49μg/ml, 74μg/ml and 178μg/ml, respectively for the inhibition of thrombin (plasma). Amongst vitamin A and its derivatives, retinoic acid showed the highest inhibition of both the forms of thrombin. Beside the effectiveness of TAM on cancer cells, it also has other effects on numerous microbes including parasite, fungi, bacteria, and some viruses such as Ebola virus and human immunodeficiency virus (HIV).Furthermore Tamoxifen can block the action of interleukin 6 and inhibit neutrophils. A study demonstrated that tamoxifen has side effects associated with neutropenia. Since tamoxifen can cause neutropenia and subsequently influence the neutrophil-to-lymphocyte ratio (NLR) value In addition it has anti malarial effect similar to chloroquine In conclusion Keywords: COVID 2019 , Retinoic acid, Endosomal toll-like receptor 3,T Cells, IFN type1, AT1, ACE2,TMPRSS2
Beijing Minhai Biotechnology Co., Ltd
This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
Butantan Institute
This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months.
Ankara University
COVID-19 (Coronavirus disease 2019) is a new infectious disease caused by a virus named as SARS-CoV2 (Severe Acute Respiratory Syndrome Coronavirus-2). Although it can have a devastating effect on many organs, the respiratory tract is particularly affected. In the course of the disease, a wide clinical spectrum is observed, from flu-like illness to lung failure. Some of the patients who survived the disease continue to have problems such as shortness of breath, fatigue, decrease in walking distance, decrease in participation in daily life activities. These problems suggest that the effects on respiratory and cardiac functions continue even after the disease ends. This study was designed to demonstrate the effects and extent of COVID-19 on cardiopulmonary capacity.
Provincial Government of Central Java, Indonesia
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.
BRAC University
In line with BRAC's overall goals to limit the COVID19 transmission, BRAC has constructed 1,000 handwashing stations coupled with other supports i.e. in-person demonstration, hygiene meetings, and soap distribution in Bangladesh. The purpose of this study is to assess the impact of public handwashing stations (HWSs) on people's hygiene behavior and health outcomes in response to the COVID-19 situation. For this, at the household level, we will collect information on self-reported handwashing practices, income, health status, and HWSs along with other relevant socio-demographic variables in detail. In addition, we will observe people's mobility, mask usage at public places, and the HWSs usage; and will associate the observed HWSs usage with their self-reported health outcomes. This study will conduct surveys on households (7,760) and public (5,820) in 20 sub-districts of Mymensingh, Khulna, and Dhaka divisions. Overall, this study is expected to directly benefit study participants and their communities by unveiling new evidence to inform BRAC's existing hygiene behavioral change programming in these communities. In addition, this information will yield future societal benefits by generating evidence on how to effectively implement and disseminate infrastructure and information that people can trust, believe, and use to form healthy hygiene habits.