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 390 of 1186Rambam Health Care Campus
Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression. Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients. Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure. Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure. Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases. Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.
Johns Hopkins University
Stem cell therapy has emerged as a revolutionary treatment for diseases that were considered untreatable only a few years ago. Umbilical cord-derived mesenchymal stem cells (UCMSCs) have been shown to repair damaged liver, kidney, heart, pancreas, skin, cartilage, and cornea in animal models and several human trials. In addition to cellular replacement through regeneration, UCMSCs mediate through paracrine signaling pathways resulting in immune modulation. Clinical manifestations of coronavirus disease 2019 (COVID-19), are believed to arise from septic shock and cytokine storm that cause acute respiratory dysfunction and acute cardiac injury. There is presently no cure for the COVID-19 viral disease; however, multi-treatment strategies are being examined. During the past two months, four reports were published that suggest, mesenchymal stem cells (MSCs), owing to their powerful immunomodulatory ability, may prevent the cytokine storm and thus reduce the COVID-19 related morbidity. All studies reported that COVID-19 patients responded favorably to MSCs therapy. These reports, taken together with the previous successes of stem cell therapy in animal models, the investigators, a seven-institution consortium, propose to explore the efficacy of UCMSC treatment in COVID-19 patients at Jinnah hospital, Lahore. The investigators propose to administer UCMSCs in patients with acute pulmonary inflammation due to COVID-19 infection with moderate to severe symptoms. In the first cohort of 15 patients, UCMSCs will be administered with three intravenous infusions of 500,000 UCMSCs per Kg body weight each on days 1, 3, and 5. The second group of five patients serving as control will only receive standard treatment. During the 30-day post-infusion period, a battery of tests will be performed to evaluate the safety and efficacy of the UCMSCs treatment. In parallel, the investigators propose a comparative study to determine COVID-19 viral count by quantitative real-time PCR and through viral coat protein ELISA, developed in the investigator advisor lab (Dr. Tauseef Butt, Progenra Inc. Philadelphia, USA) with the ultimate objective to locally developing a rapid diagnostic assay.
Shanghai Junshi Bioscience Co., Ltd.
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)
Mahidol University
This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.
Chemical Diversity Research Institute
An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
The Scientific and Technological Research Council of Turkey
In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.
University Hospital, Caen
Since the description of the first cases of infection in December 2019 in the Hubei province in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged and caused a pandemic. This new virus is responsible for an infectious disease with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The first data concerned essentially the adult population and gave a clinical description of the disease. However, data is missing in the pediatric population. The first published studies indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the case of a child with leukemia recently described with the diagnosis of COVID-19, there is currently no data about pediatric patients with an oncology history or under chemotherapeutic drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a year in France. Malignant tumor or its treatment can affect self-immunity, which could favor SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to collect data about French children with a cancer and diagnosed with COVID-19.The analysis of the collected data will refine clinical characteristics of SARS-CoV-2 infection in this population. It will be critical for elaborating recommendations for the management of COVID-19 in children with cancer.
Sentien Biotechnologies, Inc.
The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with an infectious etiology of Acute Kidney Injury (AKI). SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. SBI-101 will be integrated into the renal replacement circuit and patients will be treated for up to 24 hours.
Bandim Health Project
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
Yale University
In times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery. The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.