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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 83

Kanuni Sultan Suleyman Training and Research Hospital

Evaluation of the Effects of Ozone Therapy on Covid 19 Positive Patients

Conditions: COVID19, Ozene

Evaluation of the effects of ozone therapy given in addition to the treatment they received in covid 19 positive patients (hydroxychloroquine + azithromycin)

Population Health Research Institute

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial

Conditions: Surgery, Perioperative Complication, COVID

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on days alive at home during the 30-day follow-up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts

Duke University

Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

Conditions: COVID-19, Cancer

The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.

Vanderbilt-Ingram Cancer Center

COVID-19 and Cancer Consortium Registry

Conditions: COVID-19, Invasive Malignancy (Any Type)

In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.

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 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

Memorial Sloan Kettering Cancer Center

A Study of N-acetylcysteine in Patients With COVID-19 Infection

Conditions: COVID-19

The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator. The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.

ElectroCore INC

Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

Conditions: COVID, Corona Virus Infection, Respiratory Failure, Respiratory Distress Syndrome, Adult, ARDS, Human, SARS (Severe Acute Respiratory Syndrome)

The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.

ImmunityBio, Inc.

Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19

Conditions: COVID-19

This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.

Canadian Cancer Trials Group

Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

Conditions: Cancer, COVID-19

The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.

Janssen Scientific Affairs, LLC

Ibrutinib for the Treatment of COVID-19 in Patients Requiring Hospitalization

Conditions: Aplastic Anemia, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Monoclonal B-Cell Lymphocytosis, Monoclonal Gammopathy of Undetermined Significance, Myelodysplastic Syndrome, Symptomatic COVID-19 Infection Laboratory-Confirmed

This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.

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Status

  • Completed (607)
  • Unknown status (351)
  • Recruiting (138)
  • (-) Active, not recruiting (78)
  • Terminated (76)
  • Withdrawn (51)
  • Not yet recruiting (19)
  • Suspended (10)
  • (-) Enrolling by invitation (4)
  • (-) No longer available (1)

Intervention Type

  • Drug (94)
  • (-) Other (76)
  • Biological (75)
  • Diagnostic Test (30)
  • Behavioral (15)
  • Device (15)
  • Procedure (10)
  • (-) Dietary Supplement (8)
  • Radiation (2)

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© Reagan-Udall Foundation for the FDA