Therapeutic clinical trial

The Passive Immunity Trial of Our Nation PassItOn is evaluating a single dose of convalescent plasma in adults with acute respiratory infection symptoms and laboratory-confirmed SARS-CoV-2 infection who are hospitalized or in an emergency department and likely to be admitted. The trial will assess clinical improvement at 15 days and use of ventilation, supplemental oxygen, and acute kidney injury and cardiovascular events.

Site Menu Home. Search Health Topics. Search the NIH Guide. ACTT-1 evaluated remdesivir alone against placebo. Back to Top. A monoclonal antibody donated by Janssen Biotech, Inc. Remicade received FDA approval in to treat several chronic auto-immune inflammatory diseases.

Clinical Trial Record News Release. The Data and Safety Monitoring Board recommended that the sub-study be discontinued, due to futility. Combination monoclonal antibody treatment administered by subcutaneous injection, developed by The Rockefeller University and licensed to Bristol Myers Squibb. Clinical Trial Record. The Data and Safety Monitoring Board recommended that recruitment in the sub-study should cease, due to futility.

Two monoclonal antibodies developed by Brii Biosciences. The Data and Safety Monitoring Board determined that the therapeutics did not meet the inclusion for criteria for further enrollment in the trial, due to futility. A small-molecule therapeutic designed by Molecular Partners in partnership with Novartis. It consists of a single kind of small molecule, from a novel class of antimicrobials known as DARPins designed ankyrin repeat proteins.

This may prevent the virus from infecting human cells. Clinical Trial Record News release on trial launch Statement on pausing enrollment of critically ill patients Statement on stopping enrollment of moderately ill patients due to efficacy News release on trial results.

Clinical Trial Record Statement on trial enrollment. A tyrosine kinase inhibitor medication for the treatment of chronic immune thrombocytopenia ITP administered orally that blocks the activity of the enzyme spleen tyrosine kinase SYK , an enzyme involved in stimulating parts of the immune system. An investigational monoclonal antibody developed by Humanigen. A small molecule inhibitor of factor D alternate complement pathway , initially developed by Alexion to treat symptoms of paroxysmal nocturnal hemoglobinuria.

The therapeutic will be given in oral form, in conjunction with the antiviral drug remdesivir. This combination will be compared with placebo and remdesivir. ACTT-4 evaluated one arm of remdesivir and dexamethasone, a corticosteroid, or placebo against a second arm of remdesivir and baricitinib or placebo.

This study closed because the Data Safety Monitoring Board determined that neither treatment regimen was significantly better than the other. Non-therapeutic studies often lead to therapeutic ones.

Within therapeutic trials, there are three different phases used to evaluate new treatments. Each phase has a different goal.

Phase I studies are the most basic of clinical trials. Here, drugs are tested to evaluate the dosages of the treatment, and how often the treatment can be administered maximum tolerated dosages, MTD.

As it is unknown whether the treatment will be effective against a particular disease, people with a variety of diseases are enrolled. Drugs are given at gradually increasing dosages until there are unacceptable side effects dose-limited toxicities, DLT. The treatment is targeted at the population of patients which responded most favorably in Phase I trials, because it is believed to hold promise for that particular group of patients.

Phase III studies are those that most children will receive when newly diagnosed. These studies will test the standard treatment current best against promising alternatives that may increase cure rates or decrease side effects or late effects of treatment.

Each treatment has been shown to be effective in other studies but not yet compared to each other or the current best treatment. Usually, one treatment arm is the "standard" or the best proven current treatment.

The other new treatment has some changes or additions to determine if they cure the disease in more children, control disease longer, cause fewer or less serious side effects, or change the number of days spent in the hospital. If a clinical trial is not currently available at the time your child is diagnosed, your child will receive the best standard treatment. To learn if one treatment in a Phase III clinical trial is better, each child is assigned randomly to one of the treatments.

In most studies, we do not know which treatment is better until all the children taking part in the clinical trial have completed treatment and have been observed for several years. However, if one of the treatments is already found to be better than the others while the trial is still going on, the trial is stopped, and all children are given the better treatment. If for any reason the treatment plan is found to be not the best for your child, the plan will be changed. Individual Drug Studies Individual drug studies can be conducted at a large or small number of hospitals, depending on the purpose of the trial.

In individual drug studies, a drug manufacturer closely monitors lab tests and results from the use of the drug, and releases only a small amount of the drug during the period of the study.

These studies are usually performed at centers that are well equipped to gather the needed data and to provide a quick transfer of lab specimens. Supportive Care Studies Supportive care studies evaluate ways of helping with the side effects of treatments. These can also be performed at a few medical centers at a time or at many hospitals at once.

Target or Clear. Therefore, they are expected to substantially reduce side effects, relative to previous [therapeutic] platforms.

This allows for both penetration of solid tumors and clearance through the kidneys. Penetration of the solid tumor means quicker destruction of tumor cells, Wiesner says. But if you can diffuse through the entire tumor tissue, you can basically begin disintegrating the whole tumor from day one. After injection and circulation in the bloodstream, the CDCs find the tumor, which by nature has a porous surrounding vasculature due to rapid growth, a hallmark of cancerous tissue.

CDCs then diffuse through the tumor microenvironment in order to specifically target tumor cells. This is key: The better CDCs diffuse through the entirety of the tumor, the better they can target cells throughout the tumor, and not just those on the surface layer.

In comparison, typical ADCs only carry four drug molecules. The reason for the superior drug capacity? There are no trees to hide in between, leading to a lower drug loading capacity.