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 240 of 755Region Skane
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
Natureceuticals Sdn Bhd
A two arm open label multi-centered randomized interventional trial is proposed to assess aspects of safety and efficacy of Nuvastatic™ (Serial No: C5OSEW5050ESA) . Two parallel groups of (1:1) ratio comparing Nuvastatic™ versus standard care will be conducted on patients on oxygen saturation (SaO2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (PaO2:FiO2) at or below 300 mg Hg. Primary Outcome Measures: time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first. Secondary Outcome Measures: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14, mortality at day 28. 1. The duration of mechanical ventilation. 2. The duration of hospitalization in survivors. 3. The time (in days) from treatment initiation to death. 4. Virologic measures included the proportions with viral RNA detection over time and viral RNA titer area under-curve (auc) measurements.
Assistance Publique - Hôpitaux de Paris
Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity, specificity, predictive values)
Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)
A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in addition to currently recommended control measures.
Centre Hôpital Universitaire Farhat Hached
This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or hydroxychloroquine and azithromycin of patients with COVID-19 infection. The investigators will undertake a randomized, double-blind, controlled Trial in the region of Sousse Tunisia
Weill Medical College of Cornell University
The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.
Versailles Hospital
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older. In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity. Apart from an increase in oxygen therapy, no specific treatment is currently proposed. The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution. Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients. This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.
Bangladesh Medical Research Council (BMRC)
The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010 deaths and a crude case fatality ratio (CFR) of 6.4%. In Bangladesh, the situation is also grave. As of May 14, 2020, there were 18,863 cases and 283 deaths. In order to suppress COVID-19 transmission, it is important to diagnose COVID-19 patients, which would help in the process of quarantine and isolation of the patients and also in contact tracing. COVID-19 testing can identify the SARS-CoV-2 virus and includes methods that detect the presence of virus itself such as real time reverse-transcription-polymerase chain reaction (RT-PCR), isothermal nucleic acid amplification, antigen) and those that detect antibodies produced in response to infection. Until now, RT-PCR has been known as the best approach for - detection. It would be very useful if Bangladesh had its own locally produced RT-PCR kits, provided that the kits are no less in quality than imported kits in terms of sensitivity, specificity, price etc. The present study aims to carry out the performance evaluation of RealDetect RT-PCR Kit for COVID-19 detection. The RealDetect™ COVID-19 RT-PCR diagnostic panel is a locally produced real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals who meet SARS-CoV-2 clinical criteria. The approach is based on the RT-PCR method which uses two (Nucleocapsid 1, Nucleocapsid 2) sets of gene-specific primers and corresponding fluorescent probes to detect two specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein Nucleocapsid gene. This RT-PCR panel detects SARS-CoV-2 Ribonucleic acid (RNA) specifically. The approach does not generate any false positives to other coronaviruses or human microflora. The kit also contains a primer-probe set which detects human housekeeping gene, ribonuclease Protein (RNase P). That is, the Ribonuclease Protein (RNase P) serves as an internal reference control to monitor sample collection, ribonucleic acid (RNA) extraction, and amplification. This is a case control study. The study will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). These specimens will be blinded before handing over to Institute for Developing Science & Health Initiatives (ideSHi) for RealDetect Kit. All samples will be analyzed by Real Time PCR System. Necessary validation will also be carried out at the COVID-19 laboratory of the Dhaka Medical College Hospital and an external validation expert will be involved. The Principal Investigator (PI) will also receive the sample information regarding positive/negative status from Institute for Epidemiology, Disease Control and Research (IEDCR) and compare ideSHi and IEDCR data. Unpaired t-test, Wilcox's test, Rank test, Compare test, Mean test, Sensitivity/Specificity test, Regression analysis and Geometric mean with 95% Confidence Interval (CI) will be used to analyze the data. It needs to conduct a univariate analysis.
Boston Children's Hospital
This is a randomized double-blind placebo-controlled Phase II trial of recombinant human deoxyribonuclease I (rhDNase I) - Pulmozyme - in mechanically ventilated patients with COVID-19 pneumonia. Patients admitted to the ICU with severe COVID-19 pneumonia who require mechanical ventilation will be invited to participate in this study. Potential subjects will be identified from medical record review or from direct contact with physicians. Investigators will check medical history and confirm eligibility. Informed consent will be obtained from either the patient or designated healthcare proxy. 60 subjects will be enrolled. After obtaining informed consent, patients will be randomized 2:1 to Pulmozyme 2.5 mg BID for up to 28 days or until they are no longer receiving mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline 2.5 ml plus standard of care.
Cardresearch
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.