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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Displaying 700 of 841Siberian State Medical University
Preliminary data support the effect of Nitric Oxide (NO) on improving the oxygenation in mechanically ventilated patients and spontaneously breathing patients with COVID-19. In vitro studies showed an antiviral effect of NO against SARS-coronavirus. The optimal therapeutic regimen of NO gas in spontaneously breathing hypoxemic patients with COVID-19 is not known. We hypothesize that high concentration inhaled NO with an adjunct of continuous low dose administration between the high concentration treatments can be safely administered in hypoxemic COVID-19 patients compared to the high dose treatment alone. Prolonged administration of NO gas may benefit the patients in terms of the severity of the clinical course and time to recovery. Together with a clinical effect on ventilation-perfusion matching, a prolonged regimen would allow also an increase in antiviral activity (dose and time-dependent).
Aga Khan University
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred initially in December 2019 in the city of Wuhan, Hubei province, China. Patients mainly presented with respiratory symptoms and this novel pathogen was identified.At present, the core management of COVID-19 includes infection prevention, case detection, monitoring, and supportive care. While specific new drugs and vaccines are being researched, certain drugs that are already present in medical arsenal are under trial too. One investigational treatment being explored for COVID-19 is the use of convalescent plasma (CP) collected from recovered COVID-19 patients. Convalescent Plasma is a source of passive immune therapy- the administration of specific antibodies against a given agent for preventing or treating an infectious disease due to that agent. The main anticipated mechanism of action of Convalescent Plasma therapy in COVID19 is viral neutralization. Other possible mechanisms include antibody-dependent cellular cytotoxicity and phagocytosis. There are numerous examples in which convalescent plasma (CP) has been used successfully as post exposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses e.g. SARS-1, MERS-CoV and very recently in 2014, the Ebola virus outbreak. In SARS-CoV-2, Shen et al published a case series of 5 critically ill patients with COVID-19 and acute respiratory distress syndrome showing improvement in clinical status after transfusion of CP. Therefore, the objective of this study is to determine the safety and efficacy of transfusing convalescent plasma in patients admitted with COVID-19 at Aga Khan University Karachi, Pakistan. The investigators hypothesize that CP will decrease the length of hospital stay and overall mortality in patients with COVID-19. In this study, convalescent plasma will be collected from the donors who have been recovered from SARS-CoV-2 infection and transfused it to the patients admitted with active severe /critical COVID-19 at the Aga Khan University Hospital Karachi. STUDY DESIGN: Non-randomized open Label trial INCLUSION CRITERIA IN TREATMENT ARM: i. Inpatients at AKU with positive SARS-CoV-2 infection by rRT-PCR and who have provided written informed consent for inclusion in the trial; ii. Age ≥ 18 years; iii. Severe or immediately life-threatening COVID-19 defined by any of: - Respiratory rate ≥ 30/min; - Blood oxygen saturation ≤ 93% at room air; - Partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio < 300; - Lung infiltrates > 50% within 24 to 48 hours on radiology ( X-ray or CT scan); - Need for mechanical ventilation. - respiratory failure - septic shock - multiple organ dysfunction or failure EXCLUSION CRITERIA: i. Negative rRT-PCR from respiratory secretions or blood within 48 h prior to assessment of eligibility. ii. History of allergic reaction to blood or plasma products (as judged by the investigator). iii. Medical conditions in which receipt of 500 mL intravascular volume may be detrimental to the patient (e.g., actively decompensated congestive heart failure). iv. Enrolment in any other clinical trial for an investigational therapy. CONTROL GROUP: COVID-19 patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given Standard of Care and will be followed for study outcomes. Data from these SC patients will be used as comparator in the analysis of the study.
Shin Poong Pharmaceutical Co. Ltd.
This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ clinical trial to evaluate efficacy and safety of Pyramax in mild to moderate COVID-19 patients.
Sanofi
Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with severe coronavirus disease 2019 (COVID-19) Secondary Objectives: - To evaluate the time to onset of effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by CRP levels - To evaluate the time to onset of effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on oxygenation status - To evaluate the effect of SAR443122 relative to the control arm on total duration of supplemental oxygen requirement - To evaluate the effect of SAR443122 relative to the control arm on length of ventilator support needed - To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of severe COVID-19 - To evaluate the effect of SAR443122 relative to the control arm on mortality - To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic therapy - To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor treatment - To evaluate the safety of SAR443122 as compared to the control arm up to End of Study - To evaluate the effect of SAR443122 relative to the control arm on total duration without high flow supplemental oxygen requirements
Hospital de Infecciosas Francisco Javier Muniz
This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
Indian Council of Medical Research
Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three investigational vaccine groups and one placebo group in healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively. A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo.
ModernaTX, Inc.
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
Samaritan Health Services
Pioglitazone is an approved anti-hyperglycemic medication and is thought to have anti-inflammatory properties. This study seeks to gather safety and tolerability data related to pioglitazone when given to patients who require hospital admission for confirmed positive COVID-19 infections with elevated blood sugar levels as compared to patients who did not receive pioglitazone during their hospitalization for COVID-19.
Yale University
This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized patients with SARS-CoV-2
Hackensack Meridian Health
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.