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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.

Displaying 10 of 128

Washington University School of Medicine

A Pilot Study Evaluating the Effect of NT-I7, a Long Acting Interleukin-7, to Enhance Immune Clearance of SARS-CoV-2 (COVID-19)

Conditions: COVID-19, SARS-CoV-2

In this study, patients who have tested positive for SARS-CoV-2 by PCR testing without severe disease will be randomized on a 2:1 basis to receive a single injection of NT-I7 or placebo. All participants will receive best supportive care in addition to study treatment. The investigators hypothesize that NT-I7 can increase absolute lymphocyte count (ALC), thus potentially improve immune response to enhance viral clearance, thereby reducing duration of symptoms, minimizing contagiousness and preventing progression of severity.

Fondation Ophtalmologique Adolphe de Rothschild

Impact of Auricular Vagus Nerve Neuromodulation on COVID-19 Positive Inpatients Outcome

Conditions: COVID19, SARS-CoV Infection

The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

Columbia University

Acquiring Convalescent Specimens for COVID-19 Antibodies

Conditions: COVID-19, Coronavirus Infection, Corona Virus Infection

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

University Hospital Tuebingen

Early Versus Late ECMO Therapy in COVID-19 Induced ARDS (ECMO-VID)

Conditions: ARDS, Human, COVID-19

Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers

Tongji Hospital

Tocilizumab vs CRRT in Management of Cytokine Release Syndrome (CRS) in COVID-19

Conditions: COVID-19, SARS, Cytokine Storm, Cytokine Release Syndrome, Tocilizumab

Some patients infected with the COVID-19 can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. Tocilizumab was first approved by the U.S. FDA in 2010 for rheumatoid arthritis and might now be used to treat serious COVID-19 patients with lung damage, according to China's National Health Commission updated its treatment guidelines in 7th version.Continuous Renal Replacement Therapy (CRRT) was recommended by China's National Health Commission treatment guidelines in 1st-7th version to control sever COVID-19 patients.

Assistance Publique - Hôpitaux de Paris

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia

Conditions: Acute Hypoxemic Respiratory Failure, COVID-19

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

ELHARRAR Xavier

Prone Positioning in Spontaneously Breathing Nonintubated Covid-19 Patient: a Pilot Study

Conditions: Coronavirus Infection, Oxygen Deficiency

The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.

Burnasyan Federal Medical Biophysical Center

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19

Conditions: Acute Respiratory Tract Infection, Acute Respiratory Insufficiency, Pneumonia, Septic Shock, Hypoxemia

The purpose of the study is to evaluate an effectiveness of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drugs that will be administered to patients are: - Leitragin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

University College Hospital Galway

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Conditions: ARDS, Human, Mechanical Ventilation Complication, COVID19

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

St. Joseph's Healthcare Hamilton

Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

Conditions: Corona Virus Infection, COVID19, COVID-19

The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

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Status

  • Completed (54)
  • Unknown status (35)
  • Active, not recruiting (10)
  • Terminated (10)
  • Recruiting (8)
  • Withdrawn (6)
  • Enrolling by invitation (2)
  • Not yet recruiting (2)
  • Suspended (1)

Intervention Type

  • Drug (1460)
  • Other (1239)
  • Biological (545)
  • Diagnostic Test (415)
  • Behavioral (261)
  • Device (242)
  • Dietary Supplement (104)
  • (-) Procedure (104)
  • Combination Product (43)
  • (-) Radiation (24)
  • Genetic (13)

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© Reagan-Udall Foundation for the FDA