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.
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 70 of 530Medical University of Graz
Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in theworld, especially in terms of health system capacity and economic burden. People fromsub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus(HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIVinfection and anti-retroviral treatment (ART) in altered cardiovascular risk isquestionable and there is still need to further carry out research in this field.However, thus far it is unclear, what impact the COVID-19 co-infection in people livingwith HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims toinvestigate whether and how HIV-infection in COVID-19 patients modulates the time courseof the disease, alters cardiovascular risk, and changes vascular endothelial function andcoagulation parameters/ thrombosis risk.Methods: In this long-term study, cardiovascular research on PLHIV with or without ARTwith COVID-19 and HIV-negative with COVID-19 will be carried out via clinical andbiochemical measurements for cardiovascular risk factors and biomarkers of cardiovasculardisease (CVD). Vascular and endothelial function will be measured by brachial arteryflow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, andretinal blood vessel analyses, along with vascular endothelial biomarkers andcoagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with orwithout ART and its role in enhancement of cardiovascular risk and endothelialdysfunction will be assessed. Potential changes in these endpoints by COVID-19 will befollowed for 4 weeks across the three groups (PLHIVwith or without ART and HIVnegatives).Impact of project: The ENDOCOVID project aims to evaluate in the long-term thecardiovascular risk and vascular endothelial function in PLHIV thus revealing animportant transitional cardiovascular phenotype in COVID-19.
Reven Pharmaceuticals, Inc.
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebocontrolled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacyof RJX in patients with COVID-19.
University Hospital, Rouen
At present, the offer of tests for the serological diagnosis of CoVID-19 (detection ofIgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of avery large number of rapid diagnostic unit tests, a few dedicated high throughputautomated systems or reagents on existing open systems. The offer will continue to expandin the coming months.In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HASreport of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific councilconcerning the potential use of these serological tests at the end of the COVID-19epidemic, the Virology laboratory wishes to validate the sensitivity and specificity ofthe tests it intends to use.
Genova Inc.
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalizedmoderate COVID-19 patients
Cytocom, Inc.
This is a randomized, single blind, study. Males and females meeting inclusion criteriawho have symptoms of mild COVID-19 and in whom a positive PCR result for SARS-CoV-2 isobtained may be enrolled to the study treatment within 72 hours of the positive PCRresult. Eligible patients are those considered to be at high risk for COVID-19 diseaseprogression. This includes patients ≥ 65 years of age or with any one or more of certainmedical conditions including: cancer, COPD, cardiovascular disease, immunocompromisedstate resulting from solid organ transplant, obesity, sickle cell disease, history ofsmoking, and diabetes.
University of British Columbia
Coronavirus Disease 2019 (COVID -19) is the largest public health crisis in over acentury. There is an urgent need for high-quality population-level data to understandmodifiable risks for disease severity, transmissibility, and to develop evidence-basedprevention (i.e. vaccination), treatment and resource allocation strategies.The Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) created apopulation-based registry of suspected and confirmed consecutive cases of COVID-19. Thepurpose of this registry is to derive and validate clinical decision rules, evaluatediagnostic tests and vaccine effectiveness, and complete cohort, case-control andobservational studies to inform the pandemic response.
Kitasato University
Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when thesymptom and clinical findings exacerbate to a moderate level, patients are admitted.There is no standard treatment for mild cases. This study will investigate whetherivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderateCOVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlledtrial. Subjects are assigned to two groups, the placebo group, and the ivermectin group.The target number of each treatment arm is 120, a total of 240 cases. A single oraladministration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will beadministered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primaryendpoint with additional efficacy and safety of the process will be investigated.
Regeneron Pharmaceuticals
Primary Objective:Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acutemoderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Shin Poong Pharmaceutical Co. Ltd.
This is a multi-center, randomized, Phase 2/3 study to evaluate the safety and efficacyof pyronaridine-artesunate in participants with corona virus disease 2019 (COVID-19).Pyronaridine-artesunate has been approved in Europe, Asia and Africa under brand name ofPyramax® or Artecom® as a treatment for malaria. The study will be conducted in twostages: open-label (Stage 1) and double-blind (Stage 2).Up to approximately 402 participants (20 participants in Stage 1 and 382 participants inStage 2) are planned to be enrolled in the study and will be randomized to receive eitherArtecom® or matching placebo at a ratio of 1:1 in Stage 2. The dose of Artecom® will bedetermined by the participant's body weight, according to previously establishedguidelines.An independent Drug Safety Monitoring Board (DSMB) will be established to review thesafety at regular intervals during the conduct of the trial. The DSMB will be subject toa Charter and will review after 20 participants have been recruited, and thereafter when191 participants have been recruited.Ad-hoc DSMB meetings may be held at any time during the study if there are any majorsafety concerns. A final DSMB will be conducted when all participants have been recruitedin the trial.
Assiut University
To register pathological events occurring to all acute coronary syndrome patients comingto Assiut university heart hospital through one year during COVID- 19 pandemic