Remdesivir effective in U.S. NIH trial for advanced COVID-19

Remdesivir, an investigational nucleotide analog with broad-spectrum antiviral activity developed by the Californian biopharmaceutical company Gilead Sciences, has shown promising results for the treatment of advanced COVID-19.

Preliminary results from a clinical trial conducted by the United States National Institutes of Health show that patients who received remdesivir had a 31% faster time to recovery than those who received placebo.

Remdesivir’s trial involved 1063 hospitalised patients

The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, announced that based on a preliminary data analysis of a randomized controlled trial involving 1063 patients which started on February 21, hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered quicker than comparable patients who received placebo.

The Adaptive COVID-19 Treatment Trial (ACTT)

Known as the Adaptive COVID-19 Treatment Trial (ACTT) and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is the very first clinical trial conducted in the U.S to test an experimental COVID-19 therapy.

An impartial Data and Safety Monitoring Board (DSMB) coordinating the trial met on April 27 to review data and communicated their interim findings with the study team. Based on their analysis of the data, they observed that from the primary outcome viewpoint, time to recovery, a parameter commonly used in influenza studies, remdesivir was superior to the placebo. Recovery was defined in this study as being discharged from the hospital or returning to a normal level of activity.

Remdesivir accelerates recovery time by 31 percent

The preliminary trial results indicate that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo (p<0.001). The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received a placebo. The results also indicated a survival advantage, with a mortality rate of 8.0 percent for the remdesivir group compared to 11.6 percent for the placebo group (p=0.059).

A part of the U.S. FDA commitment to speed up the development and production of potential COVID-19 therapies, the Agency has entered into continuous talks with Gilead Sciences on making remdesivir available to patients as soon as possible.

The trial closed on 19 April for new enrollments. NIAID will soon have an update on the preparations to move forward with the ACTT study. This trial was designed as an adaptive trial aiming to integrate additional experimental treatments.

The first participant in the ACTT trial was an American repatriated after being quarantined on the Diamond Princess cruise ship docked in Yokohama, Japan. In February, he volunteered to participate in the trial at the first study site, the University of Nebraska Medical Center / Nebraska Medicine. A total of 68 sites eventually joined the study—47 in the United States and 21 in Europe and Asia.

To date, remdesivir has shown positive results in animal models for treating SARS-CoV-2 (the COVID-19 disease-causing virus) infection and has been examined in various clinical trials.

Gilead’s Phase 3 trial for 5-day and 10-day dosing duration

Gilead’s remdesivir has been administered via daily infusion for 10 days in this trial. But on the 29th of April, Gilead Sciences announced topline results from another open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease.

The clinical trial demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases at Stanford University School of Medicine, who is one of the lead investigators of the Phase 3 SIMPLE trial said:

“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course. While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”

More about the U.S. National Institutes of Health

The National Institutes of Health (NIH) is the primary United States medical research agency. NIH includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the main federal institution conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

NIAID carries out and supports research at NIH, throughout the U.S and globally, to study the causes of infectious and immune-mediated diseases, and to develop advancements for preventing, diagnosing and treating these illnesses.

More about Gilead Sciences, Inc.

Gilead Sciences, Inc. is an American research-based biopharmaceutical company discovering, developing and commercialising novel medicines in areas of unmet medical need. With operations in more than 35 countries, Gilead strives to revamp and simplify care for people with life-threatening illnesses around the world.

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