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U.S. steps up clinical trials for COVID

来源:澳门美高梅作者:澳门美高梅日期:2020-08-08阅读

The U.S. National Institutes of Health (NIH) announced on Thursday the start of a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in COVID-19 patients.

The study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad, according to a release of the NIH.

It is the second clinical trial announced by the NIH this week in an effort to step up treatment for COVID-19.

Participants must have laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. People with confirmed infection who have mild symptoms or no apparent symptoms will not be included in the study, said the NIH.

They are being randomly assigned in a 1-to-1 ratio to receive either subcutaneous interferon beta-1a plus remdesivir (combination therapy) or remdesivir alone. Neither the participants nor the study team will know who is receiving which treatment regimen.

All participants will receive standard doses of remdesivir and either interferon beta-1a or a placebo. Those in the combination therapy group will receive interferon beta-1a as a 44-microgram subcutaneous injection every other day for a total of four doses during hospitalization.

Those in the remdesivir-only group will receive a matching placebo subcutaneous injection every other day for a total of four doses during hospitalization.

Investigators will evaluate whether time to recovery is shorter in the combination therapy group relative to the remdesivir-only group, said the NIH.

Earlier this week, the NIH announced a phase 2 clinical trial which will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including an investigational therapeutic based on synthetic monoclonal antibodies (mAbs) to treat the disease.

Researchers sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, are working with clinical sites to identify potential patient volunteers currently infected with SARS-CoV-2, who have mild to moderate disease not requiring hospitalization.

They will be invited to take an experimental therapy or a placebo as part of a rigorously designed randomized clinical trial. The trial, which is known as ACTIV-2, also may investigate other experimental therapeutics later under the same trial protocol.

The United States have been stepping up research on vaccines, drugs and therapies for COVID-19 as confirmed cases hit over 4,870,000 and fatalities surpassed 159,800 as of Thursday evening, according to a tally by Johns Hopkins University.

An experimental COVID-19 vaccine being developed by the NIAID and American biotechnology company Moderna, known as mRNA-1273, started phase 3 clinical trial last week to evaluate if it can prevent COVID-19 in adults.

The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.

"Investigating a variety of different therapeutics, including monoclonal antibodies, will help ensure that we advance towards an effective treatment for people suffering from COVID-19 disease as quickly as possible," said NIAID Director Anthony Fauci.