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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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 70 of 134Soroka University Medical Center
A randomized, open-label, 2 arm, pilot trial of Lambda 180 mcg administeredsubcutaneously once weekly, for up to two weeks (2 injections at most), in addition tostandard supportive care, compared to standard supportive care alone, in a population ofCOVID-19 infected patients.patients will be randomized according to 1:1 ratio to one of the 2 trial arms: Lambda 180mcg S.C + standard care (intervention arm) or standard care only (control arm).
CMN "20 de Noviembre"
The primary objective of this study is to evaluate the effect of additional estradiolestrogen therapy on clinical response and mortality in non-severe COVID-19 patients
Boehringer Ingelheim
Currently, there is no approved treatment for COVID-19 in France, either for the acutephase, nor for the late chronic phase. the investigator suggest that nintedanib has thepotential to block the development of lung fibrosis when initiated early enough toinhibit the activation of mesenchymal cells and the progression of virus-inducedpulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrousstripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrousstripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye etal observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data arestill lacking in patients with COVID-19 and the investigators do not know how manypatients will have fibrotic sequelae from the acute illness.
Australian National University
The Can nebulised HepArin Reduce morTality and time to Extubation in Patients withCOVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospectivecollaborative individual patient data analysis of randomised controlled trials and earlyphase studies. Individual studies are being conducted in multiple countries, includingAustralia, Ireland, the USA, and the UK.Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant onchest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours orstandard care (open label studies) or placebo (blinded placebo controlled studies) for upto 10 days while mechanically ventilated. All trials will collect a minimum core dataset.The primary outcome for the meta-trial is ventilator-free days during the first 28 days,defined as being alive and free from mechanical ventilation. Individual studies may haveadditional outcomes.
University of Chicago
Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.
QuantumLeap Healthcare Collaborative
The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Johns Hopkins University
This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.
University of Melbourne
An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).
Sound Pharmaceuticals, Incorporated
The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.