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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.

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.

Displaying 110 of 129

Columbia University

Mother-infant Bonding During COVID-19

Conditions: Child Development, Mother-Infant Interaction, Relation, Parent-Child

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

ClinAmygate

Anosmia and / or Ageusia and Early Corticosteroid Use

Conditions: COVID19, Anosmia

Time to recover of Anosmia and / or ageusia and early corticosteroid use

NYU Langone Health

COVID-19 Survivorship Registry

Conditions: COVID19

COVID-19 is associated with acute pulmonary and cardiac injury. To better understand thedegree and severity of cardiopulmonary injury as well as short and long-term sequelae ofCOVID-19 infection, this study will perform longitudinal study in patients who had recentknown diagnosis of COVID-19.

Karolinska Institutet

The Effect of the Covid-19 Pandemic Among Operated Patients

Conditions: COVID19, Surgery

This project covers several research aims. In a cohort study, the investigators aim tocompare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgicaltreatment and study factors associated with good or bad outcomes.

ClinAmygate

The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice

Conditions: COVID19

The study explore the relationship between COVID-19 and the induction of autoimmunediseases.

Assistance Publique - Hôpitaux de Paris

Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN)

Conditions: COVID19, Arterial Stiffness, Endothelial Dysfunction, Diastolic Dysfunction

The purpose of the study is to evaluate the presence of early vascular aging 6 months and12 months after COVID-19 infection.

Karolinska Institutet

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Conditions: Multiple Myeloma

Prospective, single center, randomized, open label, parallel group, 2-arm study assessingthe clinical benefit in term of enhancement of overall response rate of Isatuximab incombination with CellProtect as compared to Isatuximab for the treatment of patients withnewly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) asmaintenance after SCT.

National Cancer Institute (NCI)

The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors

Conditions: Covid-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

The study investigates how the COVID-19 pandemic has impacted the psychological,financial, physical, and social well-being of adolescent and young adult (AYA) cancerpatients and survivors. AYA cancer survivors have inferior long-term survival compared tothe general population, and the negative impact of the global COVID-19 pandemic may beeven higher in this vulnerable group. The information gained from this study may providean opportunity to determine the self-reported COVID-19 specific psychological distress inAYA cancer survivors, and may lead to the development of a targeted intervention toimprove physical and psychosocial health for AYA cancer patients and survivors.

University of Siena

Genetic Bases of COVID-19 Clinical Variability

Conditions: COVID-19

GEN-COVID multicenter study aims to identify the genetic variants of the host genomeresponsible for the clinical variability of patients with COVID-19. This variability todate is only partially related to the age and comorbidities of patients. The primaryobjective of the study is therefore to identify genetic variants associated with theseverity of the disease, while the secondary objective consists in the identification ofvariants associated with longitudinal disease trajectories.This is a laboratory study that involves the conduct of genetic investigations, includingwhole exome sequencing and genome wide association studies, on human biological materialfrom patients affected by COVID-19.Clinical information useful to describe the level of disease severity will be alsocollected for each enrolled patient.A total of at least 2,000 COVID-19 patients is expected to be included.

Dr. Negrin University Hospital

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Conditions: Acute Hypoxemic Respiratory Failure

Background: There are no proven therapies specific for pulmonary dysfunction in patientswith acute hypoxemic respiratory failure (AHRF) caused by infections (includingCovid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severepneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. Theefficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.Methods: This is a multicenter, randomized, controlled, open-label clinical trial testingdexamethasone in mechanically ventilated adult patients with established AHRF (includingARDS) caused by confirmed pulmonary or systemic infections, admitted in a network ofSpanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone:either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primaryoutcome is 60-day mortality. The secondary outcome is the number of ventilator-free daysat 28 days. All analyses will be done according to the intention-to-treat principle.

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Status

  • (-) Recruiting (129)

Intervention Type

  • Other (48)
  • Drug (19)
  • Biological (14)
  • Behavioral (8)
  • Diagnostic Test (8)
  • Device (4)
  • Dietary Supplement (2)
  • Radiation (2)
  • Genetic (1)

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© Reagan-Udall Foundation for the FDA