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 380 of 897Massachusetts General Hospital
The primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from COVID-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. We aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.
University Hospital, Geneva
The Swiss population underwent a period of confinement related to the COVID-19 pandemic (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss population, certain groups were identified as vulnerable subjects by the Federal Office of Public Health. This study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.
Online PsychoTherapy Clinic
The recent COVID-19 pandemic has affected many aspects of individuals social life and its negative consequences on Canadian public health go far beyond the direct overload of the hospital care system. Self-isolation and financial uncertainty can significantly deteriorate individuals' mental health, which is only going to aggravate with prolonged physical distancing strategies. Adding to this is the personal and public trauma of lost lives and soon there will be an unprecedented epidemic of mental health problems with crushing effects on the public health sector and economy. To meet this huge new demand for an already strained health system, there is a need for innovative new approaches that significantly expand the capacity of care delivery. While it may not be possible in the short term to increase the number of mental healthcare providers or the number of hours they work, improving their time spent efficiently might be the solution. Virtual care and online delivery of psychotherapy, shown to be clinically effective, efficient and cost-effective, might be the perfect solution to address the high demand faced now. The investigators aim to establish the first academic online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care delivery could increase care capacity by four-folds. The findings from this project have the potential to influence clinical practice and policy and increase accessibility to care during COVID-19 pandemic, without sacrificing the quality of care.
Altura
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.
Aga Khan University
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred initially in December 2019 in the city of Wuhan, Hubei province, China. Patients mainly presented with respiratory symptoms and this novel pathogen was identified.At present, the core management of COVID-19 includes infection prevention, case detection, monitoring, and supportive care. While specific new drugs and vaccines are being researched, certain drugs that are already present in medical arsenal are under trial too. One investigational treatment being explored for COVID-19 is the use of convalescent plasma (CP) collected from recovered COVID-19 patients. Convalescent Plasma is a source of passive immune therapy- the administration of specific antibodies against a given agent for preventing or treating an infectious disease due to that agent. The main anticipated mechanism of action of Convalescent Plasma therapy in COVID19 is viral neutralization. Other possible mechanisms include antibody-dependent cellular cytotoxicity and phagocytosis. There are numerous examples in which convalescent plasma (CP) has been used successfully as post exposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses e.g. SARS-1, MERS-CoV and very recently in 2014, the Ebola virus outbreak. In SARS-CoV-2, Shen et al published a case series of 5 critically ill patients with COVID-19 and acute respiratory distress syndrome showing improvement in clinical status after transfusion of CP. Therefore, the objective of this study is to determine the safety and efficacy of transfusing convalescent plasma in patients admitted with COVID-19 at Aga Khan University Karachi, Pakistan. The investigators hypothesize that CP will decrease the length of hospital stay and overall mortality in patients with COVID-19. In this study, convalescent plasma will be collected from the donors who have been recovered from SARS-CoV-2 infection and transfused it to the patients admitted with active severe /critical COVID-19 at the Aga Khan University Hospital Karachi. STUDY DESIGN: Non-randomized open Label trial INCLUSION CRITERIA IN TREATMENT ARM: i. Inpatients at AKU with positive SARS-CoV-2 infection by rRT-PCR and who have provided written informed consent for inclusion in the trial; ii. Age ≥ 18 years; iii. Severe or immediately life-threatening COVID-19 defined by any of: - Respiratory rate ≥ 30/min; - Blood oxygen saturation ≤ 93% at room air; - Partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio < 300; - Lung infiltrates > 50% within 24 to 48 hours on radiology ( X-ray or CT scan); - Need for mechanical ventilation. - respiratory failure - septic shock - multiple organ dysfunction or failure EXCLUSION CRITERIA: i. Negative rRT-PCR from respiratory secretions or blood within 48 h prior to assessment of eligibility. ii. History of allergic reaction to blood or plasma products (as judged by the investigator). iii. Medical conditions in which receipt of 500 mL intravascular volume may be detrimental to the patient (e.g., actively decompensated congestive heart failure). iv. Enrolment in any other clinical trial for an investigational therapy. CONTROL GROUP: COVID-19 patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given Standard of Care and will be followed for study outcomes. Data from these SC patients will be used as comparator in the analysis of the study.
Universidad Internacional de Valencia
This study evaluates the effectiveness of a Positive Psychology intervention, that is focused on increasing the positive emotions and strengths of human beings. It is compared to the effectiveness of an online treatment with the change of the same participants before and after receiving the treatment accompanied by a chat support service vs. the treatment solely. The changes are being assessed through worldwide validated measures such as psychometrics.
University of California, Berkeley
The investigators have developed supportive text-messages in English and Spanish to help people cope with the stress and anxiety of COVID-19 social distancing. The purpose of this study is to examine if automated text-messages will improve depression and anxiety symptoms and enhance positive mood. Additionally, the investigators will compare the effectiveness of sending messages on a random schedule (using a micro-randomized trial design) or sent by a reinforcement learning policy on overall change in depression and anxiety symptoms and daily mood during the 8-week study.
Hospital Italiano de Buenos Aires
Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported. Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test
Mekelle University
The investigators will evaluate the profile of the immune response of Ethiopian population and examine its relationship with the noted low CD4+ T-cell count and underlying immune activation status among participants with COVID-19 and will compare results with those residing in Europe. In addition, this project will evaluate the performance of various rapid diagnostic tests (RDTs) for SARS-CoV-2, taking into account the above-determined immune system characteristics. We will also evaluate the effect of co-infection with parasites on COVID-19 severity
Institute of Tropical Medicine, Belgium
The objectives of this study are (1) to determine the ex vivo neutralizing capacity and the longevity of SARS-CoV-2-specific Ab responses and (2) to measure the memory B-cell responses in a cohort of health care workers (HCW) recovering from severe, mild or asymptomatic infection. By focusing on HCW, a population that is at risk for re-infection during a second epidemic wave, the correlation between nAb levels and protection is investigated.