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COVID-19 Clinical Trials and Expanded Access

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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.

Search Tips

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.

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Roche Pharma AG

Tocilizumab Treatment in Patients With COVID-19

Conditions: SARS-COV2

A phase II clinical trial will be carried out with the objective of studying the impactof the administration of Tocilizumab on the evolution of the acute respiratory distresssyndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the highmortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will notbe included. Patients will be recruited by signing an informed consent and the baselinevariables of interest will be recorded. Tocilizumab will be administered in one or twodoses, depending on the case, and will be followed up for 30 days. The response totreatment, survival and evolution will be studied. Factors associated with improvement ofARDS and survival will be identified through multivariate analyzes. The results will becompared with those reported internationally.

University of British Columbia

Investigating the Role of Biomarkers in Predicting Outcome for COVID 19

Conditions: COVID 19

Emergent experimental and anecdotal evidence has indicated that critically ill COVID-19patients demonstrate two patient sub-types (called phenotypes). In one group the diseaseprogresses slowly and patients have a low potential of developing mild respiratoryfailure, but in the other group, an exaggerated immune response(hyper-inflammation/cytokine storm) may be linked to the onset of precipitous respiratoryfailure, termed acute respiratory distress syndrome. This syndrome is responsible for alarge portion of COVID-19 associated mortality. Thus, determining links betweenhyper-inflammation and acute respiratory distress syndrome in COVID-19 patients is ofimmediate importance. Blood samples will undergo a number of analyses to help us tounderstand as much as possible about COVID-19. We will also study any differences inphysiologic and cytokine levels before and after patients are treated withimmunomodulatory therapies as part of clinical care in COVID-19 patients.

University of California, Los Angeles

COVID-19 Recovered Volunteer Research Participant Pool Registry

Conditions: Recovered From COVID-19

This is a prospective observational registry of COVID-19 recovered patients who are nolonger symptomatic. This Registry is intended to serve as a pool of individuals that canparticipate in studies associated with serological testing, characterization of immunityand immune response, vaccine development, and convalescent plasma donors.

ProgenaBiome

A Study to Explore the Role of Gut Flora in COVID-19 Infection

Conditions: Gut Microbiome, Gastrointestinal Microbiome, COVID, COVID-19, Corona Virus Infection, Coronavirus, Coronaviridae Infections, Coronavirus 19, Coronavirus-19, COVID 19

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, isshed in the stools of patients who are infected.

University of Chicago

Long Term Outcomes of Patients With COVID-19

Conditions: Critical Illness, Corona Virus Infection, Respiratory Failure, COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 willhave different burdens of mental and physical disability than those with respiratoryfailure who do not have COVID-19. Detecting these potential differences will lay animportant foundation for treating long term sequelae of respiratory failure in these twocohorts.

Medical University of Graz

COVID-19 and the Developement of Phobic Fears of Disease

Conditions: COVID19

A lot of people suffer from phobias. Phobias concerning certain diseases are not rare.This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able torise phobias in people and if those with preexisting phobias or fears were more likely todevelop a phobia concerning COVID. It will look at different subtypes - physicians,medical staff, general public (not medically affiliated) and patients with psychiatricdisorders.

Hospital Clinic of Barcelona

Long-term Effects of Coronavirus Disease 2019 on the Cardiovascular System: CV COVID-19 Registry

Conditions: SARS-COV2, COVID19, Cardiovascular Diseases, Cardiovascular Risk Factor

Patients presenting with the coronavirus-2019 disease (COVID-19) have a very high risk ofcardiovascular adverse events, including death from cardiovascular causes. Unfortunately,there are no reliable statistics on the frequency and severity of these complicationsduring the index hospitalization. Moreover, the long-term cardiovascular outcomes ofthese patients are entirely unknown. The investigators aim to perform a registry ofpatients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and determinetheir long-term cardiovascular outcomes.

University of California, San Francisco

Long-term Impact of Infection With Novel Coronavirus (COVID-19)

Conditions: COVID

LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also knownas novel coronavirus or COVID-19) who have recovered from acute infection. The study isdesigned to provide a specimen bank of samples with carefully characterized clinicaldata. LIINC specimens will be used to examine multiple questions involving the virologic,immunologic, and host factors involved in COVID-19, with a focus on understandingvariability in the long-term immune response between individuals.

Kafrelsheikh University

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized)

Conditions: COVID19

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatmentof COVID-19Mahmoud ELkazzaz(1),Tamer Haydara(2), Mohamed Abdelaal(3), Abedelaziz Elsayed(4) ,YousryAbo-amer(5), Hesham Attia(6), Quan Liu(7)' Tim Duong(8) and Heba Sahyon(9) 1. Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt. 2. Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt 3. Department of Cardiothoracic Surgery, Faculty of Medicine, Kafrelsheikh University, Egypt 4. Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Tanta University, Egypt. 5. Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt 6. Department of Immunology and Parasitology, Faculty of Science, Cairo University, Egypt. 7. School of Life Sciences and Engineering, Foshan University, Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China. 8. Montefiore Health System and Albert Einstein College of Medicine, New York, United States of America. 9. Chemistry Department, Faculty of Science, Kafrelsheikh University, Egypt. - This clinical study is the first clinical study in literature (submitted on 20 April, 2020) which demonstrated that Isotretinoin will provide complete protection against COVID-19AbstractThe COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) has infected over 100 million people causing over 2.4 million deaths overthe world, and it is still expanding. There is an urgent need for targeted and effectiveCOVID-19 treatments which has put great pressure on researchers across the world fordeveloping effective drugs. In this clinical study we attempt to demonstrate Isotretinoincould be an effective and promising treatment for SARS-CoV-2 based on the intracellularmechanism of SARS-CoV-2 transmission and consequences caused. Isotretinoin could stronglyinhibit both inflammation and viral entry in severe acute respiratory syndromecoronavirus 2 infection via decreasing the overproduction of early responseproinflammatory cytokines (interleukin-6 ) which are over expressed in COVID-19 andcontributed to disease progression, poor outcomes, vascular hyper permeability andmultiorgan failure in patients infected with COVID-19. It could also block the entry ofCOVID-19 by inhibiting androgenic factors that induce serine 2 transmembrane protease(TMPRSS2) expressions.. In addition to inhibiting of Angiotensin-converting enzyme-2(ACE2), Angiotensin T1 protein and Angiotensin II-mediated intracellular calcium releasepathway which is responsible for COVID-19 cell fusion and entry, ACE2-expressing cellsare prone to SARS-CoV-2 infection as ACE2 receptor facilitates cellular viral entry andinvasion. Moreover, isotretinoin is a potential repressor and inhibitor of papain-likeprotease (PLpro), which is a lethal protein expressed by COVID-19 genes and is an enzymeof dubiquitination which facilitates virus replication in patients with COVID-19.Thegenome of Middle East Respiratory Syndrome Coronavirus is recognized by melanomadifferentiation-associated protein-5 (MDA5), retinoic acid inducible gene-1 (RIG-1) andendosomal toll-like receptor 3 (TLR3) as pathogen-associated molecular patterns. Thisrecognition resulted in the formation of type-1 interferon (IFN1). As an evasionmechanism, virus synthesize proteins that hinder the production IFN1 in the pathway.13-cis retinoic acid induced significant upregulation of toll-like receptor 3 (TLR3),mitochondrial antiviral-signaling protein (MAVS) and IFN regulatory factor 1 expressionin a time-dependent. Furthermore, 13 cis Retinoic Acid (13 cis RA) could be an effectiveand promising treatment for SARS-CoV-2 owing to its ability to increase CD4 cells andinduce mucosal IgA antibodies that are less prone to Antibody Dependent Enhancementprocess (ADE) and responsible for passive mucosal immunity in the respiratory tract. ADEis a phenomenon in which antiviral antibodies facilitate viral infection of target immunecells and, in some cases, make a second infection worse, such as dengue fever (denguevirus), By inducing IgA antibodies, 13 cis retinoic acid enhances mucosal immunity and isknown to be a potent IgA isotype.13 Cis retinoic acid induced significant upregulation oftoll-like receptor 3 an immune boosting action that may result in an immune response todsRNA intermediate leading to the production of type I IFNs which is important to enhancethe release of antiviral proteins for the protection of uninfected cells. Isotretinointherapy has furthermore proven anti-platelet and fibrinolytic activities which mayprotect patients infected with covid-19 from widespread blood clots. From this point, wesuggest that isotretinon will be the Immunity passport" in the context of COVID-19

Regeneris Medical

Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease

Conditions: COVID-19 Pneumonia, Cyotokine Storm

The aim of this study is to evaluate the safety and efficacy of autologousadipose-derived mesenchymal cells for treating confirmed or suspected patients withSARS-CoV-2 and compromised respiratory function requiring hospitalization.The hypothesis of the Study is autologous adipose-derived mesenchymal cells given IV toeligible patients will improve clinical outcomes of COVID 19 positive patients withsevere pneumonia or ARDS by reducing or avoiding cytokine storm.

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Status

  • Unknown status (254)
  • Recruiting (129)
  • Active, not recruiting (116)
  • Enrolling by invitation (14)
  • Not yet recruiting (11)
  • Approved for marketing (3)
  • Available (3)

Intervention Type

  • Other (159)
  • Drug (134)
  • Biological (75)
  • Diagnostic Test (51)
  • Behavioral (24)
  • Device (16)
  • Procedure (11)
  • Dietary Supplement (8)
  • Radiation (7)
  • Combination Product (5)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA