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 90 of 131National Cancer Institute (NCI)
This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.
Azienda Sanitaria-Universitaria Integrata di Udine
Aim. The emerging outbreak of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread worldwide. Beside the prescription of some promising drugs as chloroquine, azithromycin, antivirals (lopinavir/ritonavir, darunavir/cobicistat) and immunomodulating agents (steroids, tocilizumab), in our patients with mild to moderate pneumonia due to SARS-CoV-2 we planned a randomize study to evaluate, respect the best available therapy (BAT), the use of autohemotherapy treatement with an oxygen/ozone (O3) gaseous mixture as adjuvant therapy. Design. Multicentric, randomized study. Participants. Clinical presentations are based upon clinical phenotypes identified by the Italian Society of Emergency and Urgency Medicine (SIMEU - Società Italiana di Medicina di Emergenza-Urgenza) and patients that meet criteria of phenotypes 2 to 4 were treat with best available therapy (BAT), and randomized to receive or not O3-autohemotherapy. Main outcome measures. The end-point were the time of respiratory improvement and earlier weaning from oxygen support: these parameters were included in the SIMEU clinical phenotypes classification.
Epicentre
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
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.
University of Campania "Luigi Vanvitelli"
Single-center study with a parallel group scheme, double-blind, randomized, placebo-controlled, to evaluate whether the addition to the investigator's hospital standard therapy of two vials of Bioarginina® per day in subjects with SARS-CoV-2 is useful for treatment of this pathology.
University Hospital Bispebjerg and Frederiksberg
The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (SPG block) on persistent headache following acute COVID-19 infection.
Wladimir Szpirt
This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
Universitas Padjadjaran
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Rhea Health Tone® as add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any change would be accompanied by updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory (inflammatory biomarkers (IL-6, hs-CRP, IFNγ), SGOT, SGPT and Creatinine, conversion rate by PCR, QTc prolongation by ECG, chest X-ray), clinical (clinical assessment, vital sign, concomitant medication, other medical conditions) and safety assessment (serious adverse event). Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Rhea Health Tone®.
Mabwell (Shanghai) Bioscience Co., Ltd.
This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the clinical efficacy and safety of MW33 injection in patients with mild or moderate COVID-19, and to evaluate its pharmacokinetic profile and immunogenicity.
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Different studies showed that acetyl L-Carnitine (LC) positively affects the development and maturation of T lymphocytes, involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of the systemic inflammatory syndrome. Given the potential protective effects of LC, it is suggested as a supportive and therapeutic option in patients with coronavirus infection. Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 2 gr of LC orally in addition to the standard of care therapy (SOC). The investigators hypothesize that the use of LC will be associated with an earlier improvement of clinical and biohumoral parameters after 14 days of LC treatment when compared to the group of patients provided with standard care.