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 840 of 923University Hospital, Ghent
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies. Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use. After the completion of the study, the samples will be stored for 30 years with consent of the participants.
National Institute of Allergy and Infectious Diseases (NIAID)
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)
Assiut University
To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease
Drug Science, UK
This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.
Asociacion Instituto Biodonostia
EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups: - Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19. - Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.
Universidad del Desarrollo
Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.
Principia Biopharma, a Sanofi Company
This is a Ph2a study that consists of a double-blind, intra-patient placebo-controlled treatment period and an open-label uncontrolled treatment period with objective to evaluate the safety, tolerability, PK and preliminary efficacy of PRN473 in up to 40 patients with mild to moderate AD. On Day 1 (Baseline) of the Blinded Period, 2 target lesions with a difference no greater than 1 point in Total Sign Score (TSS) will be randomly assigned to treatment in an intra-patient 1:1 manner, one lesion to PRN473 and the other to matching placebo. Participation will take approximately 13 weeks, including up to a 5-week screening period, a 6-week treatment period, end of study assessments 1 day after last dose, and a safety follow-up phone call 2 weeks after last dose.
Centre Hospitalier Princesse Grace
Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement
Hôpital Universitaire Sahloul
This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
Altum Pharmaceuticals INC
The IN2COVID Study is a 2-staged phase I/II double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of AP-003 (Interferon α2b) when administered via inhalation twice daily for 10 days. Participants will have a final visit at Day 11. A lead-in phase 1 substudy will be performed with at least 18 healthy adult male subjects to assess safety and tolerability of inhaled AP-003 compared to placebo for 10 days. Two cohorts of 9 subjects will be randomly assigned to receive two doses of inhaled AP-003 or placebo with an allocation ratio of 2:1. The first cohort will assess a dose of 2.5 MIU of inhaled AP-003. If no adverse events are observed, the second cohort will be conducted using a dose of 5 MIU of inhaled AP-003. Maximum tolerated dose will be determined in this phase 1 substudy. After the completion of phase 1, the study will continue with a phase 2 treatment RCT in patients with COVID-19. In this phase, 150 adults with mild or moderate COVID-19 demonstrated by SARS-CoV-2 positive polymerase chain reaction (PCR) ≤ 5 days at enrollment will be randomized 1:1 (75 in each arm) to receive nebulized AP-003 or identical placebo twice daily during 10 days.