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 530 of 597Galera Therapeutics, Inc.
A Trial of GC4419 in Patients with Critical Illness due to COVID-19
Mansoura University
Since ARDS is a major complication of COVID - 19 with subsequent formation of non-cardiogenic pulmonary edema , worsening the oxygenation of the patients and foamy and even bloody sputum formation, so the idea is to use alcohol inhalation as it reduce surface tension on the alveoli and markedly decrease sputum formation with improvement on oxygenation beside its cytolethal effect on virus lipid bilayer. A lot of researches and publications proved the role of alcohol inhalation in treatment of pulmonary edema. Alcohol inhalation may has inflammatory effect and dangerous effect on patients but this can be controlled by the actual concentration used and the way we use it according to general condition of the patient and with the help of anti - inflammatory action of Asprin .
Fundación para la Investigación Biosanitaria del Principado de Asturias
Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19). Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.
Bangladesh Medical Research Council (BMRC)
A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group. Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo. Follow up will be done every day in both group with all the parameters as stated above and will be documented. On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day. Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline
Grifols Therapeutics LLC
The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.
Clemson University
The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.
Swedish Medical Center
Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting
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.
Daewoong Pharmaceutical Co. LTD.
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
Boehringer Ingelheim
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.