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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Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19. Subjects take a 20-milligram (mg) tab of famotidine or matching placebo twice a day, increase to 1 tablet every 8 hours if not better the 2nd day, and continue same for 30 days. Vital signs, symptoms, compliance etc are rechecked daily for the 30 days and once again 60 days after starting study drug. Consent, baseline, and follow-up are handled via internet plus calls/texts/virtual visits from study nurse or doctor as needed for clarifications and compliance.
National Cancer Institute (NCI)
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
Universidad Politecnica de Madrid
Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women. Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period. Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists. The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants. In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active. This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy. It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women. In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.
Lahore General Hospital
Remdesivir is a monophosphoramidate prodrug of an adenosine analogue and it has a broad-spectrum antiviral activity against paramyxoviruses, falviviruses and coronaviruses. It showed in vitro activity on human airway epithelial cells against SARS-CoV-2. It is an investigational drug and granted an Emergency Use Authorization by Food and Drug Administration FDA, so it is under clinical trial. The potent mechanism of action of this drug is still unclear but it effects through several processes. It can interfere with nsp12 polymerase even when exoribonuclease proofreading is intact. It can also produce nucleoside triphosphate NTP that acts pharmacologically active alternate substrate of RNA-chain terminator, as a result NTP can constrain active triphosphates into viral RNA of coronaviruses. There is evidence of high genetic barrier to develop resistance against Remdesivir in coronavirus as a result of which is maintains its effectiveness in antiviral therapies against these viruses. Effectiveness of Remdesivir has been reported against different groups of coronaviruses including Alphacoronavirus NL63 and several SARS/MERS-CoV coronaviruses.
Lahore General Hospital
The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
Evergreen Therapeutics, Inc.
To study signals of efficacy and safety of a currently available dosage form (IM) of EG-009A in reducing the severity of respiratory disease in patients hospitalized with SARS-CoV-2 virus.
Hengenix Biotech Inc
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
Lahore General Hospital
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS. Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
Imuneks Farma ilac San. Tic. A.S.
This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients. The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo. The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.
Indonesia University
This study aims to analyze the effectiveness and safety of Avigan® (favipiravir) compared to Oseltamivir as an adjuvant therapy among adult COVID-19 patients. This study will be conducted in a hospital setting, recruiting adult COVID-19 patients with mild, moderate, and severe symptoms. Subjects will be randomly given Favipiravir or Oseltamivir as an adjuvant therapy to standard COVID-19 treatment. Patients will be followed up for 21 days after the first dose of intervention given. The primary outcomes of this study are the improvement of radiology results and RT PCR negative conversion during follow up. The secondary outcomes are adverse events, hospital length of stay (LOS), and Case fatality rate (CFR)