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 370 of 442Cairo University
COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020. There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy. Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based on the similarity between the replication mechanisms of the HCV and the coronaviruses. Aim of the study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients who are candidates to receive Hydroxy Chloroquine according to Egyptian MOHP protocol
Atabay Kimya Sanayi Ticaret A.S.
A single dose of Reference product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride and a single dose of Test product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions with Covid-19 Pandemic precautions.
Mansoura University
In this project, we aimed at developing new "Ready-to-Use" inhalable forms of HCQ that can be used directly through nebulization or using dry powder inhalers (DPIs). These inhaled forms would allow a simple and direct delivery of the drug (HCQ) specifically towards the throat and the lung which are the main sites for the COVID-19 viral infection. Hence, the drug can be available at higher concentrations in the throat and lungs as compared with the currently used treatment protocols, while minimizing the drug systemic concentrations and its presence in other body organs, and thus enhancing the drug efficacy with significantly limiting its side effects. Besides, using inhalable forms can be more convenient to patients suffering from gastrointestinal complications from the disease that can limit the absorption of oral forms. Moreover, the proposed inhalable forms are designed in such a way to hide the drug from the immune system (confer stealth characteristics) using FDA-approved excipients to minimize/avoid any immune response towards the drug as was noted towards it in its oral form that's used in the treatment protocol of COVID-19. In addition, the inhaled formulations will be designed to maintain the overall simplicity and scalability of the preparation which is critical during this urgent pandemic situation. The cost of the final formulation is also taken into consideration since the drug is intended for treatment of thousands or probably millions of patients around the world including countries with limited economic capabilities.
Sohaib Ashraf
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Sohaib Ashraf
The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Prof. Dr. Fridoon Jawad Ahmad
This is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
Ministry of Health, Kuwait
Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) . Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.
Alan Bryce
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Ministry of Health, Saudi Arabia
There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. The drugs we are chosen are used as clinical trials for antiviral and there is no proven guide for specificity and effectiveness against the virus so the results are different Now the clinical trials and research authorities are work speedily to target the most proven treatment for the virus so anything is infantile until now. the covid-19 with time be more explained by scientists it is steroid response disease and cause thromosis and cytokine storm , the aim of the study to inhibit viral replication and decrease the severity of the disease as antiviral and anticytokine storm , antithrombosis Zinc is a mineral element needed to regulate adaptive immune cells' functions. Higher level of intracellular zinc showed to increase intracellular pH; which affect on RNA-dependent RNA polymerase and decrease replication mechanism of RNA viruses. Therefore, drugs that described as zinc ionophores could be used with zinc supplement to act as antiviral against many RNA viruses including SARS-CoV-2 Quercetin is natural compound act as zinc ionophore to cause zinc influx intracellular. Quercetin is a safe natural anti-oxidant and anti-inflammatory polyphenolic compound that found in various natural sources include onion, red grapes, honey and citrus fruits. It was shown that quercetin has the ability to chelate zinc ions and act as zinc ionophore. Therefore, quercetin could have antiviral activity against many RNA viruses . Quercetin, a flavonoid found in fruits and vegetables, has unique biological properties that may improve mental/physical performance and reduce infection risk ; These properties form the basis for potential benefits to overall health and disease resistance, including anti-carcinogenic, anti-inflammatory, antiviral, antioxidant, and psychostimulant activities, as well as the ability to inhibit lipid peroxidation, platelet aggregation and capillary permeability, and to stimulate mitochondrial biogenesis .There are various studies that report the immunomodulatory effect of bromelain . Bromelain activates natural killer cells and augments the production of granulocyte-macrophage-colony stimulating factor, IL-2, IL-6 and decreases the activation of Thelper cells. Thus, bromelain decreases the majority of inflammatory mediators and has demonstrated a significant role as an anti-inflammatory agent in various conditions Vitamin C is known as an essential anti-oxidant.,and enzymatic co-factor for physiological reactions such as hormone production, collagen synthesis and immune potentiation . Naturally, an insufficiency of vitamin C leads to severe injuries to multiple organs, especially to the heart and brain, since they are both highly aerobic organs that produce more oxygen radicals. In fact, studies of in vivo effect on vitamin C are difficult since most animals, except human and some primate, are capable of synthesizing vitamin C endogenously
Ministry of Health, Turkey
This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.