Clinical Trial To Test Immune Modulation for Hospitalized Covid-19 Patients
NIH launched a clinical trial to test whether early intensive immune modulation for hospitalized Covid-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 volunteers at research sites around the world. The trial is supported by NIAID in partnership with NCATS.
Symptoms from an unregulated immune response to Covid-19 can include severe respiratory distress, which can be fatal. Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized Covid-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.
“Patients with milder cases of Covid-19 are often administered one immune modulator and a second treatment is added only if the patient becomes severely ill,” said NIAID Acting Director Dr. Hugh Auchincloss. “It is possible that adding a second therapeutic earlier in the patient’s treatment could prevent progression to severe illness and improve recovery. This clinical study aims to answer that question.”
The drug—abatacept (or Orencia)—used to test the strategy of early intensification of immune modulation is manufactured by Bristol Myers Squibb. It was first approved by the FDA as a treatment for arthritis. Researchers think it may also be useful as an immune modulator for Covid-19 by tamping down overactive immune responses.
Participants may enroll in the current trial if they are receiving supplemental low-flow oxygen upon being hospitalized for Covid-19 infection at one of the participating study sites. In addition to receiving the local standard of care, participants will be randomized to immediately receive either a single intravenous infusion of abatacept with dosage dependent on the patient’s weight, or a placebo infusion. Study investigators will closely track participants’ progress over the course of 60 days.
More than 270 international sites plan to participate in this program, which has continuous enrollment as Covid-19 surges in different parts of the world.