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.

Search Tips

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.

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Sound Pharmaceuticals, Incorporated

SPI-1005 Treatment in Severe COVID-19 Patients

Conditions: COVID19, Coronavirus, Coronavirus Infection, Corona Virus Infection

The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.

Sound Pharmaceuticals, Incorporated

SPI-1005 Treatment in Moderate COVID-19 Patients

Conditions: COVID19, Corona Virus Infection, Coronavirus, Coronavirus Infection

The study is a randomized, double-blind, placebo-controlled, dose escalation,multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR testfor novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.

Johns Hopkins University

Decitabine for Coronavirus (COVID-19) Pneumonia- Acute Respiratory Distress Syndrome (ARDS) Treatment: DART Trial

Conditions: COVID-19

This is a a randomized double blind placebo controlled Phase 2 trial with a 12 patientlead-in to evaluate safety, prior to full enrollment to an additional 28 patients (for atotal of 40 patients) to assess efficacy of decitabine in the treatment of critically illpatients with COVID-ARDS. The patients will be randomized in a 1:1 ratio to receivestandard of care plus Decitabine or standard of care plus saline based placebo. Theprimary objective is to determine safety and efficacy of decitabine for COVID-19 ARDSbased on clinical improvement on a 6-point clinical scale.

QuantumLeap Healthcare Collaborative

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Conditions: COVID-19

The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.

University of Chicago

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Conditions: COVID-19

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19)pneumonia and related inflammation. Given limited global supplies, clarification of theoptimal tocilizumab dose is critical. We conducted an open-label, randomized, controlledtrial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg).Randomization was stratified on remdesivir and corticosteroid at enrollment. The primaryoutcome was the time to recovery. The key secondary outcome was 28-day mortality.

Sanofi

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Conditions: Primary Progressive Multiple Sclerosis

Primary Objective:To determine the efficacy of SAR442168 compared to placebo in delaying disabilityprogression in primary progressive multiple sclerosis (PPMS)Secondary Objectives:To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magneticresonance imaging (MRI) lesions, cognitive performance, physical function, and quality oflife To evaluate safety and tolerability of SAR442168 To evaluate populationpharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety Toevaluate pharmacodynamics of SAR442168

Pfizer

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Conditions: Neoplasm Metastasis

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 asMonotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

Mesoblast International Sàrl

Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Conditions: Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

The objectives of this intermediate-size expanded access protocol are to assess thesafety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

Biomed Industries, Inc.

NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection

Conditions: Coronavirus Infection, Severe Acute Respiratory Infection, Severe Acute Respiratory Syndrome Coronavirus 2

This Phase 2/3 trial evaluates four treatment strategies for non-critically illhospitalized participants (not requiring ICU admission and/or mechanical ventilation)with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir withor without Dexamethasone.

Uppsala University Hospital

Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome

Conditions: ARDS, Human, COVID

This is an open label, dose escalating safety study of the advanced therapyinvestigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed withSARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to theBerlin Definition, and who are on respirator/ventilator (used synonymously in thisprotocol) support due to respiratory insufficiency with or without concomitantcirculatory problems, will be included and treated with a single dose of KI-MSC-PL-205.