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COVID-19 Clinical Trials and Expanded Access

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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.

Displaying 30 of 134

Shin Poong Pharmaceutical Co. Ltd.

The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients

Conditions: COVID19

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.

Sheba Medical Center

Synthetic CBD as a Therapy for COVID-19

Conditions: COVID19, CBD

The study aim to test proof of concept of CBD treatment for efficacy and safety inpatients suffering with mild COVID-19 infection. The CBD will be delivered via oildroplets not containing THC, compared to placebo.

Corat Therapeutics Gmbh

Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Conditions: COVID19

Primary objectives Part 1: - To evaluate the safety and tolerability of COR-101 compared to placeboSecondary objectives Part 1: - To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 - To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

Qurient Co., Ltd.

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor

Conditions: Solid Tumor, Advanced Cancer, Metastatic Cancer

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability,pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluatesafety and anti- tumor activity of Q702 administered orally.

MedRegen LLC

MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients

Conditions: COVID-19, ARDS, Human, Stem Cells, Regeneration

This study consists of two parts.Part A (Phase I):A Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects to Assessthe Safety, Pharmacokinetics, Pharmacodynamics of MRG-001Part B (Phase 2):A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-controlled, Multi-center Studyin Hospitalized Patients Infected with Severe and Critical SARS-CoV-2 to Assess theSafety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

Sanofi

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Conditions: Plasma Cell Myeloma Refractory

The purpose of this umbrella study is to evaluate isatuximab when combined with novelagents with or without dexamethasone in participants with relapsed or refractory myeloma.Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlledexperimental substudies. Substudies 04 and 05 are independent experimental substudies.

Op-T LLC

1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide.

Conditions: Healthy

This is a first-in-human study, Phase 1, randomized, placebo-controlled, double blindedstudy that will be conducted in 2 parts.

Beijing 302 Hospital

A Trial of Novaferon in Asymptomatic or Mild COVID-19 Patients

Conditions: SARS-CoV2 Infection

This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.

Ministry of Health, Thailand

Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19

Conditions: COVID19

The purpose of this study is to examine the effect of Andrographis Extract, BoesenbergiaExtract compared to standard treatment in asymptomatic COVID patients.

TCU and UNTHSC School of Medicine

Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

Conditions: SARS-CoV-2 Acute Respiratory Disease, SARS-CoV2 Infection, Cytokine Storm

To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of carevs current standard of care with the primary efficacy endpoint being the proportion ofsubjects alive and free of ventilator support, defined as intubation and requiringmechanical ventilation, at Day 28 from time of randomization.

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Status

  • Unknown status (64)
  • Active, not recruiting (37)
  • Recruiting (19)
  • Enrolling by invitation (5)
  • Not yet recruiting (4)
  • Available (3)
  • Approved for marketing (2)

Intervention Type

  • (-) Drug (134)
  • Other (17)
  • Biological (11)
  • Dietary Supplement (4)
  • Combination Product (3)
  • Device (1)
  • Procedure (1)
  • Radiation (1)

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA